Effects of ultrasound-guided serratus plane block combined with general anesthesia on postoperative early quality of recovery and analgesia in patients undergoing transapical transcatheter aortic valve implantation surgery: a randomized controlled trial

Effects of ultrasound-guided serratus plane block combined with general anesthesia on postoperative early quality of recovery and analgesia in patients undergoing transapical transcatheter aortic valve implantation surgery: a randomized controlled trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Effects of ultrasound-guided serratus plane block combined with general anesthesia on postoperative early quality of recovery and analgesia in patients undergoing transapical transcatheter aortic valve implantation surgery: a randomized controlled trial cheng xiao, Fang Chen, Lei Cao, Ming Yang, Yuting Tan, Guoyun Lin, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3917241/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 02 Jul, 2024 Read the published version in Trials → Version 1 posted 5 You are reading this latest preprint version Abstract Background Compared to traditional thoracotomy, transapical transcatheter aortic valve implantation (TAVI) surgery offers reduced trauma and faster recovery, fostering the adoption of enhanced recovery after surgery (ERAS) protocols in cardiac surgery. Despite these advancements, postoperative pain management has received insufficient attention. The potential effects of multi-mode analgesia, including ultrasound-guided serratus anterior plane block (SAPB), on postoperative pain and early quality of recovery have not been widely studied, lacking comprehensive prospective evidence. Therefore, this study aims to investigate the impact of SAPB combined with general anesthesia on early recovery quality and analgesic efficacy in transapical TAVI patients. Methods This prospective, randomized controlled study will enroll 70 patients undergoing transapical TAVI, randomly allocated to either the SAPB group or the control group. The primary outcome, assessed using quality of recovery-40 (QOR-40) scale, focuses on the quality of recovery at 24 h and 48 h postoperatively. Secondary outcomes include the visual analog scale (VAS) pain scores at rest and during coughing at 6 h, 12 h, 24 h, and 48 h after surgery, frequency of patient-controlled analgesia (PCA) utilization at 24 h and 48 h, opioid consumption at 24 h and 48 h, time and frequency of rescue analgesia and severe pain at 24 h and 48 h, incidence of nausea and vomiting at 48 h after surgery and dosage of antiemetic drugs. Discussion The purpose of our study is to evaluate the effects of ultrasound-guided SAPB combined with general anesthesia on postoperative early quality of recovery and analgesia in transapical TAVI patients. The results obtained may provide valuable insight for the implementation of multi-mode analgesia and enhanced ERAS in this specific patient population. Trial registration China Clinical Trial Register ChiCTR2300068584. Registered on 24 February 2023. Serratus anterior plane block Transcatheter aortic valve implantation Postoperative recovery quality Analgesia Figures Figure 1 Figure 2 Administrative information Title {1} Effects of ultrasound-guided serratus plane block combined with general anesthesia on postoperative early quality of recovery and analgesia in patients undergoing transapical transcatheter aortic valve implantation surgery: a randomized controlled trial Trial registration{2a，2b} China Clinical Trial Register ChiCTR2300068584. Registered on 24 February 2023 Protocol version {3} Version 1.0 of 24 February 2023 Funding {4} The study was funded by the National Nature Science Foundation of China（Project No.82171265） Author details {5a} Department of Anesthesiology, Xinqiao Hospital of Chongqing, Second Affiliated Hospital of Army Medical University, PLA, Chongqing 400037, China Name and contact information for the trial sponsor {5b} Name：Guiying Yang Address: Department of Anesthesiology, Xinqiao Hospital of Chongqing, Second Affiliated Hospital of Army Medical University, PLA, Chongqing 400037, China. Email: [email protected] Role of sponsor {5c} The sponsor neither participates in the trial process nor in the decision to submit the results. Background and rationale {6a} Aortic valve disease is a prevalent valvular disorder encountered in clinical settings. Traditionally, the mainstay treatment for improving patient outcomes has been open-heart aortic valve replacement surgery, a procedure characterized by its highly invasiveness, requiring cardiopulmonary bypass and cardiac arrest. This approach, particularly challenging for elderly patients or those with multiple comorbidities, was associated with considerable early postoperative mortality rates. The breakthrough came with the first TAVI procedure in France in 2002, revolutionizing heart valve replacement through an interventional approach[ 1 ]. In recent years, TAVI has gained popularity, particularly suitable for high-risk patients[ 2 ]. Transapical TAVI presents several advantages, including operating in the direction of blood flow, shorter procedural distances, fewer intracardiac manipulations, reduced valve displacement risks and the ability to overcome poor peripheral vascular conditions. Additionally, it significantly decreases contrast agent usage and exhibits lower incidences of stroke and organ embolisms[ 3 ]. Despite its advantages, including minimal incision and fast recovery compared to traditional surgery, postoperative pain remains a significant challenge. Ultrasound-guided regional block, crucial components of multimodal analgesia, are widely utilized in routine clinical practice. SAPB is a chest wall nerve blockade technique[ 4 ], wherein local anesthetics (LAs) are diffused into the plane of serratus anterior muscle under ultrasound guidance. This effectively blocks the lateral cutaneous branches of intercostal nerves[ 5 ], infiltrating the long thoracic and thoracodorsal nerves, providing analgesia to the anterolateral chest wall. SAPB also assists in reducing the secretion of postoperative pain mediator, suppressing inflammatory responses, and decreasing inflammatory cytokine release. Additionally, it can reduce opioid consumption and its associated adverse effects, which is particularly relevant for elderly patients, especially those with severe systemic complications, thus contributing to the quality of postoperative recovery. Its application spans breast surgeries, thoracic surgeries, and rib fracture surgeries[ 6 , 7 ]. However, the literature on the application of ultrasound-guided SAPB in minimally invasive cardiac surgeries, especially transapical TAVI, remains limited. Berthoud[ 8 ] and Ling Peng[ 9 ] reported patients successfully completed apical TAVI surgery under SAPB due to serious complications. Furthermore, Berthoud compared the therapeutic effects of SAPB and local incision infiltration for postoperative pain management in minimally invasive cardiac surgery. The results showed that SAPB can effectively alleviate postoperative pain in patients undergoing minimally invasive cardiac surgery and positively impact patient prognosis[ 10 ]. Furthermore, the integration of multimodal analgesia with regional block technique can improve analgesic efficacy while mitigating the adverse effects associated with opioid analgesics. However, achieving meaningful clinical outcomes require optimal postoperative recovery. Anesthesia and postoperative recovery constitute a multidimensional and intricate process. The QOR-40 scale is widely utilized in clinical settings to evaluate early postoperative recovery quality following anesthesia and surgery. Recognized for its suitability, feasibility, effectiveness, reliability, and precision the QOR-40 scale is considered a optimal standard for assessing postoperative recovery[ 11 ]. Additionally, researchers have identified that preoperative low QoR-40 scores can predict poor postoperative recovery, and early effective interventions can enhance postoperative recovery quality, thus improving patient quality of life[ 12 ]. Therefore, establishing a direct correlation between ultrasound-guided SAPB and post-transapical TAVI surgery recovery quality necessitates further prospective data. Our study seeks to examine the impact of ultrasound-guided SAPB on early postoperative recovery quality and analgesic efficacy in patients undergoing transapical TAVI procedures. By refining further multi-mode analgesia and ERAS protocols of this surgery, we aim to improve the postoperative rehabilitation quality and optimize the utilization of medical resources. Objectives {7} The aim of this study is to investigate the influence of SAPB combined with general anesthesia on early recovery quality and analgesic efficacy in patients undergoing transapical TAVI. Trial design {8} This is single-center, double-blind, randomized controlled trial aimed at investigating the impact of ultrasound-guided SAPB on early postoperative recovery quality and analgesic effectiveness in patients undergoing transapical TAVI. The study flow chart is depicted in Fig. 1. Our research received funding support from the National Natural Science Foundation of China (Project No.82171265). Methods: Participants, interventions and outcomes Study setting {9} The study will be conducted at the Second Affiliated Hospital of Army Medical University, PLA. Participant enrollment began in February 2023. The protocol adheres to the principles outlined in the Declaration of Helsinki and follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT). Eligibility criteria {10} Inclusion criteria Patients will undergo a face-to-face screening 1 day prior to surgery based on the following eligibility criteria: (1) Adult patients aged40–70 years (2) ASA II ~ IV classification (3) Patients planning to undergo transapical TAVI under general anesthesia (4) Patients expressing willingness to participate in this study and signed informed consent. Exclusion criteria Patients meeting any of the following criteria will be excluded from the study: (1) Allergy to Las (2) History of mental illness or taking psychotropic drugs (3) Severe abnormalities in coagulation function (4) Long-term use of analgesics or sedatives (5) History of drug abuse, alcohol, or opioid abuse (6) Recent acute pain or chronic pain (7) Postoperative mechanical ventilation ≥ 24 hours (8) Decline to participate in the study (9) Participants retain the right to withdraw from the study at their discretion for any reason or if researchers determine their inclusion is inappropriate. Who will take informed consent? {26a} Enrollment of eligible participants will be supervised by a designated member of the research team. Following a comprehensive oral explanation of the study, including its potential benefits and risks, patients or their legally authorized representative will be asked to sign the informed consent form approved by the institutional review committee. Participants and their legal authorized representatives will be informed that participation is entirely voluntary, and they have the right to withdraw from the trial at any time. Additional consent provisions for collection and use of participant data and biological specimens {26b} Not applicable. We will not utilize the date and biological specimens of participants for ancillary studies. Interventions Explanation for the choice of comparators {6b} Currently, there is limited research on the analgesic effectiveness of SAPB in transapical TAVI. Establishing a direct correlation between SAPB and the quality of recovery following transapical TAVI surgery requires more prospective data for validation. This study aims to investigate the impact of SAPB on the postoperative early recovery quality and analgesic efficacy in patients undergoing transapical TAVI surgery, and to solve the contradiction between the patients who can't tolerate large doses of opioids and the huge hemodynamic changes due to pain and subsequently affecting postoperative recovery quality. The study seeks to optimize the multi-mode analgesia and ERAS for this operation, with the goal of enhancing the postoperative recovery quality and optimizing the medical resources utilization. Currently, other studies on regional block have used 0.9% saline as control, making it ethically feasible to have a blank control group in this study. Intervention description {11a} Ultrasound-guided SAPB will be conducted after induction of general anesthesia. Patient will be positioned supine with the upper limb abducted, and the ultrasonic probe will be located in the 5th intercostal space along the left axillary line. The probe’s direction will be adjusted to identify the tissue structures such as latissimus dorsi, pectoralis major, pectoralis minor and serratus anterior. Using an in-plane technique, a 22-G nerve block needle will be advanced to the surface of the serratus anterior muscle and aspirated to ensure no blood and gas. Subsequently, 2 ml of local anesthetic mixture (0.4% ropivacaine + 10 mg dexamethasone) will be slowly injected. The injection will be performed while observing the spread of the anesthetic between the fascia layers, as indicated by a hypoechoic area on ultrasound and additional mixture will be slowly injected. The control group will be given 40ml normal saline. Criteria for discontinuing or modifying allocated interventions {11b} Withdrawal criteria are as the follows: (1) Patient or legal representative requests to withdraw from the study (2) Changes in the surgical procedure may occur during surgery (3) The investigator may decide to terminate the trial due to other unforeseen reasons. Strategies to improve adherence to interventions {11c} All SAPB procedures, surgeries, and assessments will be consistently performed by the same anesthesiologist, surgeon, and assessor, respectively. Randomization and monitoring processes will be conducted by independent researchers to ensure fairness and protocol adherence. The principal investigator will be responsible for all aspects of the recruitment process and any amendment to the study. All the experiments will strictly adhere to the research plan, ensuring reliability and effectiveness of our results. Relevant concomitant care permitted or prohibited during the trial {11d} Patients will be prepared in accordance with cardiopulmonary bypass, and standard monitoring will be established, including electrocardiograph (ECG), non-invasive blood pressure (NIBP), pulse oxygen saturation (SpO 2 ), body temperature (T), bispectral index (BIS) and cerebral oxygen, with an external automatic defibrillation patch attached. Radial artery and right internal jugular vein catheterization, under local anesthesia, will facilitate monitoring of invasive arteriovenous pressure. General anesthesia induction will involve midazolam (0.03 ~ 0.08 mg/kg), etomidate (0.2 ~ 0.6 mg/kg), rocuronium (0.6 ~ 0.9 mg/kg), sufentanil (0.3 ~ 0.4 µg/kg). Tracheal tubes will be inserted when the BIS value decreased to 40 ~ 50, initiating mechanical ventilation with a tidal volume of 6 to 8 mL/kg, respiratory rate of 12 to 15/min, and a 1:1 air-oxygen mixture, maintaining ETCO2 between 35 and 45 mmHg. The anesthesia will be maintained with propofol (4 ~ 6 mg/kg/h), remifentanil (0.08 ~ 0.3 ug/kg/min), and sevoflurane (1 ~ 2 vol%). Heart rate and mean arterial pressure will be maintained within ± 20% of baseline, except during rapid ventricular pacing. Blood potassium level will be maintained between 4.5 ~ 5.5 mmol/L and BIS will be kept between 40 ~ 60 throughout operation. Patients will be delivered to cardiac surgery intensive care unit postoperatively for standardized monitoring and management. A postoperative patient-controlled intravenous analgesia (PCIA) regimen will be established as part of a multimodal pain regimen, with sufentanil (2.5 µg/ml, limit dose 200 ug) combined with dexmetomidine (3 ug/ml, limit dose 200 ug) and tropisetron 5 mg. The PCIA pump will be programmed for a 2mL bolus with a lockout interval of 15 min and a basal infusion of 4 mL/h. Rescue analgesia will include paracetamol and tramadol hydrochloride tablets (one tablet, p.o) for VAS > 4 at rest, and 1mg of hydromorphone intravenously for severe pain (VAS > 7). Patients will be educated on PCIA pump usage. Provisions for post-trial care {30} All study participants will receive standard care. We will closely monitor them throughout the postoperative period to promptly identify any potential complications and implement intervention measures as necessary. Outcomes {12} Primary and secondary outcomes The primary outcome will assess the quality of recovery at 24 h and 48 h, measured using the QoR-40 scale. The secondary outcomes include: (1) VAS pain scores: assessment at rest and during coughing at 6 h, 12 h, 24 h, and 48 h post-surgery (2) Frequency of PCA utilization: evaluation at 24 h and 48 h following surgery (3) Opioid consumption: quantification at 24 h and 48 h post-surgery (4) Time and frequency of rescue analgesia and severe pain: analysis at 24 h and 48 h after surgery (5) Incidence of nausea and vomiting: determination at 48 h post-surgery, along with the dosage of antiemetic drugs. Participant timeline {13} The schedule of enrollment, interventions, and assessments is shown in Fig. 2. Enrolment Allocation Post-allocation TIMEPOINT** -1 day Surgery day 6 h after surgery 12 h after surgery 24 h after surgery 48 h after surgery Enrollment Eligibility screen X Informed consent X Allocation X INTERVENTIONS : SAPB group X Control group X ASSESSMENTS : QOR-40 X X X VAS pain scores X X X X Times of PCA X X Opioid consumption X X Rescue analgesia X X Severe pain X Nausea X Vomit X Dosage of antiemetic drugs X Figure 2 Participant timeline. SAPB: Serratus Anterior Plane Block; QOR-40: Quality of Recovery-40 scale; PCA: patient-controlled analgesia Sample size {14} The sample size calculation is based on the primary outcome. According to a prior publication, where mean of group 1 was 167 and the mean of group 2 was 184, with known group standard deviations of 23 [ 13 ], a sample size of 33 for each group (66 in total) will be required to achieve a power of 80% to detect the difference at a two-side α level of 0.05, taking into account a dropout rate of 10%. Ultimately, we plan to include 35 participants in each group. Recruitment {15} Patients will be provided with comprehensive information about the research procedures, including potential risks, the benefits and postoperative follow-up, during pre-anesthesia clinic consultations to ensure thorough understanding and enhance patient compliance. Recruitment will be conducted at the Second Affiliated Hospital of Army Medical University, PLA. Assignment of interventions: allocation Sequence generation {16a} Eligible patients will be randomly allocated to either the ultrasound-guided SAPB group or the control group at a 1:1 allocation ratio after providing written informed consent. The randomization sequence will be generated by an independent researcher using SPSS software version 26.0 (IBM, New York, USA). Concealment mechanism {16b} The randomized results will be securely sealed in opaque envelopes and stored separately until the end of the study. To maintain unbiased assignment and minimize potential confounding factors, the investigators responsible for generating the random sequences will not be involved in recruitment, anesthesia administration, and outcome evaluation. Preoperative interview researchers, unaware of the random allocation number, will screen and recruit participants and completed the QOR-40 scale one day before surgery. Implementation {16c} As soon as the patients enters the operation room, the attending anesthesiologist will open the corresponding numbered envelope, verify the patient’s allocation and proceed to implement the corresponding anesthesia plan accordingly. Assignment of interventions: Blinding Who will be blinded {17a} Due to the nature of the study, blinging of the attending anesthesiologist is not feasible. However, patients, outcome assessors, surgeons and nursing staff will remain blinded until the completion of the study analysis. Procedure for unblinding if needed {17b} While we do not anticipate the need for unblinding, if necessary, such as the occurrence of a research-related serious adverse event, the principal investigator or data manager will have access to the group assignment and will report any unblinding promptly. Data collection and management Plans for assessment and collection of outcomes {18a} Research data for this study will be collected from electronic medical records systems or case report forms (CRFs). Preoperative date, including demographics, medical history, medication history, supplementary examinations, and pre-operative assessment, will be completed by pre-operative visitors. The anesthesiologist will record intraoperative date. The QOR-40 scale one day before surgery and postoperative outcomes assessment will be collected by a dedicated assessor. To ensure scientific rigor of our study, all researchers will be trained on how to collect, record and store date before the trial start. All information will be strictly confidential and used solely for research purpose. After data collection, it will be double-entered into Microsoft Excel system and check by two researchers. The principal investigator will conduct a thorough check for any defects in the raw date again. Participants’ personal information will be kept confidential. Plans to promote participant retention and complete follow-up {18b} During the preoperative visit, researchers will provide detailed explanation of the intraoperative management and postoperative follow-up process. Data management {19} All date will be anonymized, with CRFs abbreviated as initials, and electronic date is coded. Electronic date will be stored on a dedicated computer with double password protection, while paper CRFs will be securely stored in our research center with password-locks. All original documents will be retained for 5 years after the study is completed Confidentiality {27} Patients will continue to be enrolled until the required number is reached. All date will be anonymized, with CRFs abbreviated as initials, and electronic date is coded. All original documents will only be accessible to researchers with the original ID and password. Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33} Not applicable. No samples will be collected for this study. Statistical methods Statistical methods for primary and secondary outcomes {20a} All normally distributed continuous variables will be expressed as mean ± standard deviation and analyzed with Student’s t-test. For non-normal distributed date, the Mann-Whitney U test will be used, and results will be presented as median and interquartile interval. Categorical variables will be described with frequencies (%) and compared using the chi-square test or Fisher’s exact test. A 95% confidence interval (CI) for differences in means (for continuous outcomes) or relative risks (for categorical outcomes) will be calculated. A P-value < 0.05 will be considered statistically significant. Statistical analyses will be performed using SPSS software version 26 (IBM, New York, USA). Interim analyses {21b} No interim analyses will be conducted due to the small number of patients and the expected low incidence of serious adverse events. Methods for additional analyses (e.g. subgroup analyses) {20b} No subgroup analyses are planned. Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c} The likelihood of missing values in our primary outcome is very low. If missing date occur, multiple imputation techniques will be employed to accurately estimate them. Plans to give access to the full protocol, participant level-data and statistical code {31c} Date sets, statistical codes, and complete protocols analyzed by the institute will be available upon reasonable request to the principal investigator. This approach ensures accuracy, repeatability and promotes further study and cooperation. Oversight and monitoring Composition of the coordinating centre and trial steering committee {5d} The steering committee, composed of principal investigator, sub- investigator and two clinicians, will guided and supervise the implementation and progress of the trial. Quarterly meetings will be convened to monitor the latest developments in the trial, ensuring that the research design and interpretation of remain relevant to current clinical practice. The committee has the authority to make decisions regarding trial modifications based on specific circumstances and assumes medical responsibility for the patients involved. Composition of the data monitoring committee, its role and reporting structure {21a} This trial is a single-center RCT with relatively small sample size and low intervention risk, and there is no date monitoring committee established. The principal investigator will review all the summarized date, and an independent auditor with expertise will conduct monthly audit. The steering committee will monitor study development quarterly, while the ethics committee will conduct an annual follow-up review. Adverse event reporting and harms {22} SAPB, integrated into our multi-mode analgesia approach, will be conducted under precise visual ultrasound guidance and standardized skilled operation. Anesthesia safety will be strictly controlled by experienced anesthesiologists within the team. Any adverse effects or unpredictable complications will be diligently documented and promptly reported to the Ethics Committee as part of our annual report. Frequency and plans for auditing trial conduct {23} There is no Data Monitoring Committee (DMC) established for this study. Instead, an independent auditor with expertise will conduct monthly audits. Additionally, the steering committee and auditor will perform repeated audits every three months to ensure the accuracy and validity of the date. Furthermore, the ethics committee will conduct an annual follow-up review. Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25} Any modifications to the research plan (version 1.0) will be promptly communicated to the principal investigator and the research ethics committee of the second affiliated hospital of army military medical university. A revised plan will be issued following thorough examination and approval. Dissemination plans {31a} The study aims to optimize multi-mode analgesia and enhance ERAS for transapical TAVI, aligning with diagnosis related groups (DRG) in medical management. Results will be disseminated at relevant academic conferences and published in peer-reviewed journals. Both positive and negative findings will be reported. Discussion This single-center, randomized controlled trial aims to investigate the effect of ultrasound-guided SAPB on the early recovery quality and analgesic of patients undergoing transapical TAVI surgery. Transapical TAVI, a minimally invasive surgical method for aortic valve lesions, offers a promising alternative for elderly and high-risk patients who may be not suitable candidates for traditional surgery. As evidence-based medicine continues to unfold, the indications for TAVI are expanding globally, leading to increased surgical volume and a gradual extension of indications to younger, lower risk and longer life expectancy groups[ 14 , 15 ]. However, perioperative analgesia and postoperative recovery of this minimally invasive cardiac surgery have not received widespread attention. Despite the small incision on transapical TAVI surgery, injuries to the skin and deep tissue, intercostal nerve damage[ 16 ], postoperative drainage tube stimulation and inflammatory reaction can still lead to severe postoperative pain. The degree of pain is related to postoperative complications and mortality. In addition, many patients undergoing these procedures are frail elderly individuals who are especially susceptible to the hemodynamic fluctuations induced by pain. As evidence-based medicine continues to evolve, optimizing postoperative pain management becomes increasingly crucial. A comprehensive and individualized analgesia and rehabilitation program are vital. Perioperative multimodal analgesia, particularly reginal block-based approaches, plays a pivotal role in promoting rehabilitation. It can reduce postoperative acute pain and potential chronic pain by reducing pain sensitization stemming from surgical injury and opioid use. While regional block like epidural analgesia and paraspinal nerve block have shown effectiveness for transapical TAVI, concerns about heparinization-related risks may limit their clinical benefits. SAPB is a fascial plane block with minimal impact on peripheral blood vessels, presents a safer and more maneuverable alternative without sympathetic block[ 17 ]. To address the gaps in evidence regarding SAPB's effectiveness in acute regional analgesia following minimally invasive cardiac surgery, this trial evaluates the analgesic effect of SAPB in transapical TAVI using measures such as opioid consumption, analgesic pump pressing times, Visual Analog Scale (VAS) pain scores at rest and during coughing, and remedial analgesia time. Dexamethasone, a long-acting synthetic glucocorticoid, is utilized as an adjuvant to LAs to extend their duration[ 18 , 19 ] and mitigate postoperative nausea, vomiting and chills. In our study, we aim to enhance the duration of analgesia and achieve a more pronounced and sustained effect by combining dexamethasone with ropivacaine. Postoperative recovery quality, a complex and dynamic process, is a critical patient-centered outcome, which can be evaluated from the aspects of physiology, psychology and social adaptation. QOR-40 scale is the best tool to evaluate the quality of early postoperative recovery after clinical intervention based on clinical and research verification. It includes five dimensions: physical comfort, pain, emotional state, physical independence, psychological support. With good validity, reliability, responsiveness and clinical acceptability, QOR-40 is widely used in various perioperative environments[ 13 , 20 ]. Through this comprehensive assessment, our study aims to provide valuable prospective evidence on regional analgesia efficacy in this population, facilitating optimization of multimodal analgesia and ERAS protocols while enhancing postoperative rehabilitation and medical resource utilization. In conclusion, the findings from this study aim to enrich the existing knowledge base, shedding light on the efficacy of SAPB in transapical TAVI and potentially guiding improvements in clinical practice to bolster patient outcomes. We acknoledge some limitations in our study. Firstly, our primary outcome is assessed at 24 and 48 hours postoperatively, providing insights into early recovery but lacking long-term follow-up to evaluate sustained intervention impact and potential complications. In addition, while we explore the effectiveness of SAPB, uncertainty persists regarding the optimal concentration and dosage of LAs and adjuvants in the block. Future high-quality research is warranted to explore this aspect further, elucidating the most effective drug combinations and furnishing instructive insights for clinical practice. Trial status At the time of manuscript submission, we are conducting this investigation and expect to complete it by January 2025. This is protocol version 1.0, completed on February 24, 2023. Trial recruitment was initiated on March 1, 2023. Abbreviations TAVI Transcatheter aortic valve implantation ERAS Enhanced recovery after surgery SAPB Serratus Anterior Plane Block QoR-40 Quality of Recovery-40 scale VAS Visual analogue score LAs Local anesthetics PCIA Patient-controlled intravenous analgesia Declarations Acknowledgements Not applicable. Availability of data and materials {29} References Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. 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Russo M, Corcione N, Cammardella AG, Ranocchi F, Lio A, Saitto G, Nicolo F, Pergolini A, Polizzi V, Ferraro P, et al. Transcatheter aortic valve implantation in patients with age =70 years: experience from two leading structural heart disease centers</at. Minerva Cardiol Angiol. 2023;71(3):324–32. Ancona MB, Toscano E, Moroni F, Ferri LA, Russo F, Bellini B, Sorropago A, Mula C, Festorazzi C, Gamardella M, et al. Patients younger than 70 undergoing transcatheter aortic valve implantation: Procedural outcomes and mid-term survival. Int J Cardiol Heart Vasc. 2021;34:100817. Font MC, Navarro-Martinez J, Nadal SB, Munoz CG, Galiana-Ivars M, Montero PC. Continuous Analgesia Using a Multi-Holed Catheter in Serratus Plane for Thoracic Surgery. Pain Physician. 2016;19(4):E684–685. Yu S, Valencia MB, Roques V, Aljure OD. Regional analgesia for minimally invasive cardiac surgery. J Card Surg. 2019;34(11):1289–96. Krom RJ, Welsby IJ, Fuller M, Barbas AS, Gao Q, Anwar IJ, Dunkman WJ. 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Cite Share Download PDF Status: Published Journal Publication published 02 Jul, 2024 Read the published version in Trials → Version 1 posted Reviewers agreed at journal 22 May, 2024 Reviewers invited by journal 22 May, 2024 Editorial decision: Major revision 22 May, 2024 Editor assigned by journal 21 Mar, 2024 First submitted to journal 19 Feb, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3917241","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":305473959,"identity":"bc46be8a-2cd3-4c08-9a0b-a50872e089d1","order_by":0,"name":"cheng xiao","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAxklEQVRIiWNgGAWjYDACZjApx8/A3tj44AMJWowlG3gONxvOIMEuoBaJ9DZpDmLU6razP/7AUGEgYXDzYYM0A4OdnG4DAS1mh3nMJBjOALXcTmwwLmBINjY7QFgLGwNj2586kJbkGQwHErcR1gJ0GOM/kMMONhzmIU4Lg4EEYwNQyw3GxmYitYD8csxAQvJMYjPjDANi/HL+ODDEagwk+I4ff/7jQ4WdHEEtIMD8B0gogFUaEKEcDuQbSFE9CkbBKBgFIwoAACgUQhnSFhT8AAAAAElFTkSuQmCC","orcid":"https://orcid.org/0000-0003-4200-2904","institution":"The Second Affiliated Hospital Of Army Medical University: Xinqiao Hospital","correspondingAuthor":true,"prefix":"","firstName":"cheng","middleName":"","lastName":"xiao","suffix":""},{"id":305473960,"identity":"97fcc0e7-c173-4bce-b279-d21137c539e8","order_by":1,"name":"Fang Chen","email":"","orcid":"","institution":"The Second Affiliated Hospital Of Army Medical University: Xinqiao Hospital","correspondingAuthor":false,"prefix":"","firstName":"Fang","middleName":"","lastName":"Chen","suffix":""},{"id":305473961,"identity":"7cf092ad-0a0e-47af-96f5-7021cb60b03f","order_by":2,"name":"Lei Cao","email":"","orcid":"","institution":"The Second Affiliated Hospital Of Army Medical University: Xinqiao Hospital","correspondingAuthor":false,"prefix":"","firstName":"Lei","middleName":"","lastName":"Cao","suffix":""},{"id":305473962,"identity":"ad87f0ef-93cf-4be1-9f9d-0e117c55b9c3","order_by":3,"name":"Ming Yang","email":"","orcid":"","institution":"The Second Affiliated Hospital Of Army Medical University: Xinqiao Hospital","correspondingAuthor":false,"prefix":"","firstName":"Ming","middleName":"","lastName":"Yang","suffix":""},{"id":305473963,"identity":"4fd630d7-4f84-4260-b780-2bf411319a2c","order_by":4,"name":"Yuting Tan","email":"","orcid":"","institution":"The Second Affiliated Hospital Of Army Medical University: Xinqiao Hospital","correspondingAuthor":false,"prefix":"","firstName":"Yuting","middleName":"","lastName":"Tan","suffix":""},{"id":305473964,"identity":"bcfbafaa-04d8-4c79-8a39-e38fdead6cf8","order_by":5,"name":"Guoyun Lin","email":"","orcid":"","institution":"The Second Affiliated Hospital Of Army Medical University: Xinqiao Hospital","correspondingAuthor":false,"prefix":"","firstName":"Guoyun","middleName":"","lastName":"Lin","suffix":""},{"id":305473965,"identity":"fc7feb74-de5e-4e5c-82d5-9f0481fe5131","order_by":6,"name":"Guiyin Yang","email":"","orcid":"","institution":"The Second Affiliated Hospital Of Army Medical University: Xinqiao Hospital","correspondingAuthor":false,"prefix":"","firstName":"Guiyin","middleName":"","lastName":"Yang","suffix":""},{"id":305473966,"identity":"84ffd704-59dd-496b-b2ed-2bd68fb4d3e6","order_by":7,"name":"Sheng Jing","email":"","orcid":"","institution":"The Second Affiliated Hospital Of Army Medical University: Xinqiao Hospital","correspondingAuthor":false,"prefix":"","firstName":"Sheng","middleName":"","lastName":"Jing","suffix":""},{"id":305473967,"identity":"b9d212e2-7256-4ede-9b22-d70ae94fb982","order_by":8,"name":"Hong Li","email":"","orcid":"","institution":"The Second Affiliated Hospital Of Army Medical University: Xinqiao Hospital","correspondingAuthor":false,"prefix":"","firstName":"Hong","middleName":"","lastName":"Li","suffix":""}],"badges":[],"createdAt":"2024-02-01 11:52:07","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3917241/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3917241/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s13063-024-08252-0","type":"published","date":"2024-07-02T15:55:06+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":58067642,"identity":"4340f00c-2e03-4e06-b669-a2be60e5a257","added_by":"auto","created_at":"2024-06-10 18:01:44","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":456407,"visible":true,"origin":"","legend":"\u003cp\u003eLegend not included with this version\u003c/p\u003e","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-3917241/v1/4ebdad0ac1c2710f9fa7bebf.jpeg"},{"id":58068381,"identity":"54a3a324-6757-40d8-a050-09a2aaa7212f","added_by":"auto","created_at":"2024-06-10 18:09:44","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":45549,"visible":true,"origin":"","legend":"\u003cp\u003eParticipant timeline. SAPB: Serratus Anterior Plane Block; QOR-40: Quality of Recovery-40 scale; PCA: patient-controlled analgesia\u003c/p\u003e","description":"","filename":"F1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-3917241/v1/a89993b3bb4dd9797b28f52c.jpg"},{"id":59509019,"identity":"43c9e982-ed19-4888-90ad-3e59c6578512","added_by":"auto","created_at":"2024-07-02 15:55:11","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1579692,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3917241/v1/00fadab8-eb5d-40d9-a911-be93706fda6e.pdf"}],"financialInterests":"","formattedTitle":"Effects of ultrasound-guided serratus plane block combined with general anesthesia on postoperative early quality of recovery and analgesia in patients undergoing transapical transcatheter aortic valve implantation surgery: a randomized controlled trial","fulltext":[{"header":"Administrative information","content":"\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"574\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"31.18466898954704%\" valign=\"top\"\u003e\n \u003cp\u003eTitle {1}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"68.81533101045297%\" valign=\"top\"\u003e\n \u003cp\u003eEffects of ultrasound-guided serratus plane block combined with general anesthesia on postoperative early quality of recovery and analgesia in patients undergoing transapical transcatheter aortic valve implantation surgery: a randomized controlled trial\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"31.18466898954704%\" valign=\"top\"\u003e\n \u003cp\u003eTrial registration{2a，2b}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"68.81533101045297%\" valign=\"top\"\u003e\n \u003cp\u003eChina Clinical Trial Register ChiCTR2300068584. Registered on 24 February 2023\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"31.18466898954704%\" valign=\"top\"\u003e\n \u003cp\u003eProtocol version {3}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"68.81533101045297%\" valign=\"top\"\u003e\n \u003cp\u003eVersion 1.0 of 24 February 2023\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"31.18466898954704%\" valign=\"top\"\u003e\n \u003cp\u003eFunding {4}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"68.81533101045297%\" valign=\"top\"\u003e\n \u003cp\u003eThe study was funded by the National Nature Science Foundation of China（Project No.82171265）\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"31.18466898954704%\" valign=\"top\"\u003e\n \u003cp\u003eAuthor details {5a}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"68.81533101045297%\" valign=\"top\"\u003e\n \u003cp\u003eDepartment of Anesthesiology, Xinqiao Hospital of Chongqing, Second Affiliated Hospital of Army Medical University, PLA, Chongqing 400037, China\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"31.18466898954704%\" valign=\"top\"\u003e\n \u003cp\u003eName and contact information for the trial sponsor {5b}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"68.81533101045297%\" valign=\"top\"\u003e\n \u003cp\u003eName：Guiying Yang\u003c/p\u003e\n \u003cp\u003eAddress: Department of Anesthesiology, Xinqiao Hospital of Chongqing, Second Affiliated Hospital of Army Medical University, PLA, Chongqing 400037, China.\u003c/p\u003e\n \u003cp\u003eEmail: [email protected]\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"31.18466898954704%\" valign=\"top\"\u003e\n \u003cp\u003eRole of sponsor {5c}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"68.81533101045297%\" valign=\"top\"\u003e\n \u003cp\u003eThe sponsor neither participates in the trial process nor in the decision to submit the results.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"Background and rationale {6a}","content":"\u003cp\u003eAortic valve disease is a prevalent valvular disorder encountered in clinical settings. Traditionally, the mainstay treatment for improving patient outcomes has been open-heart aortic valve replacement surgery, a procedure characterized by its highly invasiveness, requiring cardiopulmonary bypass and cardiac arrest. This approach, particularly challenging for elderly patients or those with multiple comorbidities, was associated with considerable early postoperative mortality rates. The breakthrough came with the first TAVI procedure in France in 2002, revolutionizing heart valve replacement through an interventional approach[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn recent years, TAVI has gained popularity, particularly suitable for high-risk patients[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. Transapical TAVI presents several advantages, including operating in the direction of blood flow, shorter procedural distances, fewer intracardiac manipulations, reduced valve displacement risks and the ability to overcome poor peripheral vascular conditions. Additionally, it significantly decreases contrast agent usage and exhibits lower incidences of stroke and organ embolisms[\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Despite its advantages, including minimal incision and fast recovery compared to traditional surgery, postoperative pain remains a significant challenge.\u003c/p\u003e \u003cp\u003eUltrasound-guided regional block, crucial components of multimodal analgesia, are widely utilized in routine clinical practice. SAPB is a chest wall nerve blockade technique[\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e], wherein local anesthetics (LAs) are diffused into the plane of serratus anterior muscle under ultrasound guidance. This effectively blocks the lateral cutaneous branches of intercostal nerves[\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e], infiltrating the long thoracic and thoracodorsal nerves, providing analgesia to the anterolateral chest wall. SAPB also assists in reducing the secretion of postoperative pain mediator, suppressing inflammatory responses, and decreasing inflammatory cytokine release. Additionally, it can reduce opioid consumption and its associated adverse effects, which is particularly relevant for elderly patients, especially those with severe systemic complications, thus contributing to the quality of postoperative recovery. Its application spans breast surgeries, thoracic surgeries, and rib fracture surgeries[\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. However, the literature on the application of ultrasound-guided SAPB in minimally invasive cardiac surgeries, especially transapical TAVI, remains limited. Berthoud[\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e] and Ling Peng[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e] reported patients successfully completed apical TAVI surgery under SAPB due to serious complications. Furthermore, Berthoud compared the therapeutic effects of SAPB and local incision infiltration for postoperative pain management in minimally invasive cardiac surgery. The results showed that SAPB can effectively alleviate postoperative pain in patients undergoing minimally invasive cardiac surgery and positively impact patient prognosis[\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eFurthermore, the integration of multimodal analgesia with regional block technique can improve analgesic efficacy while mitigating the adverse effects associated with opioid analgesics. However, achieving meaningful clinical outcomes require optimal postoperative recovery. Anesthesia and postoperative recovery constitute a multidimensional and intricate process. The QOR-40 scale is widely utilized in clinical settings to evaluate early postoperative recovery quality following anesthesia and surgery. Recognized for its suitability, feasibility, effectiveness, reliability, and precision the QOR-40 scale is considered a optimal standard for assessing postoperative recovery[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. Additionally, researchers have identified that preoperative low QoR-40 scores can predict poor postoperative recovery, and early effective interventions can enhance postoperative recovery quality, thus improving patient quality of life[\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Therefore, establishing a direct correlation between ultrasound-guided SAPB and post-transapical TAVI surgery recovery quality necessitates further prospective data.\u003c/p\u003e \u003cp\u003eOur study seeks to examine the impact of ultrasound-guided SAPB on early postoperative recovery quality and analgesic efficacy in patients undergoing transapical TAVI procedures. By refining further multi-mode analgesia and ERAS protocols of this surgery, we aim to improve the postoperative rehabilitation quality and optimize the utilization of medical resources.\u003c/p\u003e\n\u003ch3\u003eObjectives {7}\u003c/h3\u003e\n\u003cp\u003eThe aim of this study is to investigate the influence of SAPB combined with general anesthesia on early recovery quality and analgesic efficacy in patients undergoing transapical TAVI.\u003c/p\u003e\n\u003ch3\u003eTrial design {8}\u003c/h3\u003e\n\u003cp\u003eThis is single-center, double-blind, randomized controlled trial aimed at investigating the impact of ultrasound-guided SAPB on early postoperative recovery quality and analgesic effectiveness in patients undergoing transapical TAVI. The study flow chart is depicted in Fig.\u0026nbsp;1. Our research received funding support from the National Natural Science Foundation of China (Project No.82171265).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e"},{"header":"Methods: Participants, interventions and outcomes","content":"\u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eStudy setting {9}\u003c/h2\u003e \u003cp\u003eThe study will be conducted at the Second Affiliated Hospital of Army Medical University, PLA. Participant enrollment began in February 2023. The protocol adheres to the principles outlined in the Declaration of Helsinki and follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eEligibility criteria {10}\u003c/h2\u003e \u003cdiv id=\"Sec7\" class=\"Section3\"\u003e \u003ch2\u003eInclusion criteria\u003c/h2\u003e \u003cp\u003ePatients will undergo a face-to-face screening 1 day prior to surgery based on the following eligibility criteria:\u003c/p\u003e \u003cp\u003e(1) Adult patients aged40\u0026ndash;70 years\u003c/p\u003e \u003cp\u003e(2) ASA II\u0026thinsp;~\u0026thinsp;IV classification\u003c/p\u003e \u003cp\u003e(3) Patients planning to undergo transapical TAVI under general anesthesia\u003c/p\u003e \u003cp\u003e(4) Patients expressing willingness to participate in this study and signed informed consent.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eExclusion criteria\u003c/h2\u003e \u003cp\u003ePatients meeting any of the following criteria will be excluded from the study:\u003c/p\u003e \u003cp\u003e(1) Allergy to Las\u003c/p\u003e \u003cp\u003e(2) History of mental illness or taking psychotropic drugs\u003c/p\u003e \u003cp\u003e(3) Severe abnormalities in coagulation function\u003c/p\u003e \u003cp\u003e(4) Long-term use of analgesics or sedatives\u003c/p\u003e \u003cp\u003e(5) History of drug abuse, alcohol, or opioid abuse\u003c/p\u003e \u003cp\u003e(6) Recent acute pain or chronic pain\u003c/p\u003e \u003cp\u003e(7) Postoperative mechanical ventilation\u0026thinsp;\u0026ge;\u0026thinsp;24 hours\u003c/p\u003e \u003cp\u003e(8) Decline to participate in the study\u003c/p\u003e \u003cp\u003e(9) Participants retain the right to withdraw from the study at their discretion for any reason or if researchers determine their inclusion is inappropriate.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eWho will take informed consent? {26a}\u003c/h2\u003e \u003cp\u003eEnrollment of eligible participants will be supervised by a designated member of the research team. Following a comprehensive oral explanation of the study, including its potential benefits and risks, patients or their legally authorized representative will be asked to sign the informed consent form approved by the institutional review committee. Participants and their legal authorized representatives will be informed that participation is entirely voluntary, and they have the right to withdraw from the trial at any time.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003eAdditional consent provisions for collection and use of participant data and biological specimens {26b}\u003c/h2\u003e \u003cp\u003eNot applicable. We will not utilize the date and biological specimens of participants for ancillary studies.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eInterventions\u003c/h2\u003e \u003cdiv id=\"Sec12\" class=\"Section3\"\u003e \u003ch2\u003eExplanation for the choice of comparators {6b}\u003c/h2\u003e \u003cp\u003eCurrently, there is limited research on the analgesic effectiveness of SAPB in transapical TAVI. Establishing a direct correlation between SAPB and the quality of recovery following transapical TAVI surgery requires more prospective data for validation. This study aims to investigate the impact of SAPB on the postoperative early recovery quality and analgesic efficacy in patients undergoing transapical TAVI surgery, and to solve the contradiction between the patients who can't tolerate large doses of opioids and the huge hemodynamic changes due to pain and subsequently affecting postoperative recovery quality. The study seeks to optimize the multi-mode analgesia and ERAS for this operation, with the goal of enhancing the postoperative recovery quality and optimizing the medical resources utilization.\u003c/p\u003e \u003cp\u003eCurrently, other studies on regional block have used 0.9% saline as control, making it ethically feasible to have a blank control group in this study.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eIntervention description {11a}\u003c/h2\u003e \u003cp\u003eUltrasound-guided SAPB will be conducted after induction of general anesthesia. Patient will be positioned supine with the upper limb abducted, and the ultrasonic probe will be located in the 5th intercostal space along the left axillary line. The probe\u0026rsquo;s direction will be adjusted to identify the tissue structures such as latissimus dorsi, pectoralis major, pectoralis minor and serratus anterior. Using an in-plane technique, a 22-G nerve block needle will be advanced to the surface of the serratus anterior muscle and aspirated to ensure no blood and gas. Subsequently, 2 ml of local anesthetic mixture (0.4% ropivacaine\u0026thinsp;+\u0026thinsp;10 mg dexamethasone) will be slowly injected. The injection will be performed while observing the spread of the anesthetic between the fascia layers, as indicated by a hypoechoic area on ultrasound and additional mixture will be slowly injected. The control group will be given 40ml normal saline.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eCriteria for discontinuing or modifying allocated interventions {11b}\u003c/h2\u003e \u003cp\u003eWithdrawal criteria are as the follows:\u003c/p\u003e \u003cp\u003e(1) Patient or legal representative requests to withdraw from the study\u003c/p\u003e \u003cp\u003e(2) Changes in the surgical procedure may occur during surgery\u003c/p\u003e \u003cp\u003e(3) The investigator may decide to terminate the trial due to other unforeseen reasons.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eStrategies to improve adherence to interventions {11c}\u003c/h2\u003e \u003cp\u003eAll SAPB procedures, surgeries, and assessments will be consistently performed by the same anesthesiologist, surgeon, and assessor, respectively. Randomization and monitoring processes will be conducted by independent researchers to ensure fairness and protocol adherence. The principal investigator will be responsible for all aspects of the recruitment process and any amendment to the study. All the experiments will strictly adhere to the research plan, ensuring reliability and effectiveness of our results.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eRelevant concomitant care permitted or prohibited during the trial {11d}\u003c/h2\u003e \u003cp\u003ePatients will be prepared in accordance with cardiopulmonary bypass, and standard monitoring will be established, including electrocardiograph (ECG), non-invasive blood pressure (NIBP), pulse oxygen saturation (SpO\u003csub\u003e2\u003c/sub\u003e), body temperature (T), bispectral index (BIS) and cerebral oxygen, with an external automatic defibrillation patch attached. Radial artery and right internal jugular vein catheterization, under local anesthesia, will facilitate monitoring of invasive arteriovenous pressure. General anesthesia induction will involve midazolam (0.03\u0026thinsp;~\u0026thinsp;0.08 mg/kg), etomidate (0.2\u0026thinsp;~\u0026thinsp;0.6 mg/kg), rocuronium (0.6\u0026thinsp;~\u0026thinsp;0.9 mg/kg), sufentanil (0.3\u0026thinsp;~\u0026thinsp;0.4 \u0026micro;g/kg). Tracheal tubes will be inserted when the BIS value decreased to 40\u0026thinsp;~\u0026thinsp;50, initiating mechanical ventilation with a tidal volume of 6 to 8 mL/kg, respiratory rate of 12 to 15/min, and a 1:1 air-oxygen mixture, maintaining ETCO2 between 35 and 45 mmHg.\u003c/p\u003e \u003cp\u003eThe anesthesia will be maintained with propofol (4\u0026thinsp;~\u0026thinsp;6 mg/kg/h), remifentanil (0.08\u0026thinsp;~\u0026thinsp;0.3 ug/kg/min), and sevoflurane (1\u0026thinsp;~\u0026thinsp;2 vol%). Heart rate and mean arterial pressure will be maintained within \u0026plusmn;\u0026thinsp;20% of baseline, except during rapid ventricular pacing. Blood potassium level will be maintained between 4.5\u0026thinsp;~\u0026thinsp;5.5 mmol/L and BIS will be kept between 40\u0026thinsp;~\u0026thinsp;60 throughout operation.\u003c/p\u003e \u003cp\u003ePatients will be delivered to cardiac surgery intensive care unit postoperatively for standardized monitoring and management. A postoperative patient-controlled intravenous analgesia (PCIA) regimen will be established as part of a multimodal pain regimen, with sufentanil (2.5 \u0026micro;g/ml, limit dose 200 ug) combined with dexmetomidine (3 ug/ml, limit dose 200 ug) and tropisetron 5 mg. The PCIA pump will be programmed for a 2mL bolus with a lockout interval of 15 min and a basal infusion of 4 mL/h. Rescue analgesia will include paracetamol and tramadol hydrochloride tablets (one tablet, p.o) for VAS\u0026thinsp;\u0026gt;\u0026thinsp;4 at rest, and 1mg of hydromorphone intravenously for severe pain (VAS\u0026thinsp;\u0026gt;\u0026thinsp;7). Patients will be educated on PCIA pump usage.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eProvisions for post-trial care {30}\u003c/h2\u003e \u003cp\u003eAll study participants will receive standard care. We will closely monitor them throughout the postoperative period to promptly identify any potential complications and implement intervention measures as necessary.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003eOutcomes {12}\u003c/h2\u003e \u003cdiv id=\"Sec19\" class=\"Section3\"\u003e \u003ch2\u003ePrimary and secondary outcomes\u003c/h2\u003e \u003cp\u003eThe primary outcome will assess the quality of recovery at 24 h and 48 h, measured using the QoR-40 scale.\u003c/p\u003e \u003cp\u003eThe secondary outcomes include:\u003c/p\u003e \u003cp\u003e(1) VAS pain scores: assessment at rest and during coughing at 6 h, 12 h, 24 h, and 48 h post-surgery\u003c/p\u003e \u003cp\u003e(2) Frequency of PCA utilization: evaluation at 24 h and 48 h following surgery\u003c/p\u003e \u003cp\u003e(3) Opioid consumption: quantification at 24 h and 48 h post-surgery\u003c/p\u003e \u003cp\u003e(4) Time and frequency of rescue analgesia and severe pain: analysis at 24 h and 48 h after surgery\u003c/p\u003e \u003cp\u003e(5) Incidence of nausea and vomiting: determination at 48 h post-surgery, along with the dosage of antiemetic drugs.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec20\" class=\"Section2\"\u003e \u003ch2\u003eParticipant timeline {13}\u003c/h2\u003e \u003cp\u003eThe schedule of enrollment, interventions, and assessments is shown in Fig.\u0026nbsp;2.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"No\" id=\"Tabb\" border=\"1\"\u003e \u003ccolgroup cols=\"7\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eEnrolment\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAllocation\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"4\" nameend=\"c7\" namest=\"c4\"\u003e \u003cp\u003ePost-allocation\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTIMEPOINT**\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-1 day\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eSurgery day\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e6 h after surgery\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e12 h after surgery\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003e24 h after surgery\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003e48 h after surgery\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEnrollment\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eEligibility screen\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eInformed consent\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAllocation\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eINTERVENTIONS\u003c/b\u003e:\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSAPB group\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eControl group\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eASSESSMENTS\u003c/b\u003e:\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eQOR-40\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eVAS pain scores\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eTimes of PCA\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eOpioid consumption\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eRescue analgesia\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSevere pain\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eNausea\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eVomit\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eDosage of antiemetic drugs\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cb\u003eFigure\u0026nbsp;2\u003c/b\u003e Participant timeline. SAPB: Serratus Anterior Plane Block; QOR-40: Quality of Recovery-40 scale; PCA: patient-controlled analgesia\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec21\" class=\"Section2\"\u003e \u003ch2\u003eSample size {14}\u003c/h2\u003e \u003cp\u003eThe sample size calculation is based on the primary outcome. According to a prior publication, where mean of group 1 was 167 and the mean of group 2 was 184, with known group standard deviations of 23 [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e], a sample size of 33 for each group (66 in total) will be required to achieve a power of 80% to detect the difference at a two-side α level of 0.05, taking into account a dropout rate of 10%. Ultimately, we plan to include 35 participants in each group.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec22\" class=\"Section2\"\u003e \u003ch2\u003eRecruitment {15}\u003c/h2\u003e \u003cp\u003ePatients will be provided with comprehensive information about the research procedures, including potential risks, the benefits and postoperative follow-up, during pre-anesthesia clinic consultations to ensure thorough understanding and enhance patient compliance. Recruitment will be conducted at the Second Affiliated Hospital of Army Medical University, PLA.\u003c/p\u003e \u003cdiv id=\"Sec23\" class=\"Section3\"\u003e \u003ch2\u003eAssignment of interventions: allocation\u003c/h2\u003e \u003cdiv id=\"Sec24\" class=\"Section4\"\u003e \u003ch2\u003eSequence generation {16a}\u003c/h2\u003e \u003cp\u003eEligible patients will be randomly allocated to either the ultrasound-guided SAPB group or the control group at a 1:1 allocation ratio after providing\u003c/p\u003e \u003cp\u003ewritten informed consent. The randomization sequence will be generated by an independent researcher using SPSS software version 26.0 (IBM, New York, USA).\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec25\" class=\"Section3\"\u003e \u003ch2\u003eConcealment mechanism {16b}\u003c/h2\u003e \u003cp\u003eThe randomized results will be securely sealed in opaque envelopes and stored separately until the end of the study. To maintain unbiased assignment and minimize potential confounding factors, the investigators responsible for generating the random sequences will not be involved in recruitment, anesthesia administration, and outcome evaluation. Preoperative interview researchers, unaware of the random allocation number, will screen and recruit participants and completed the QOR-40 scale one day before surgery.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec26\" class=\"Section3\"\u003e \u003ch2\u003eImplementation {16c}\u003c/h2\u003e \u003cp\u003eAs soon as the patients enters the operation room, the attending anesthesiologist will open the corresponding numbered envelope, verify the patient\u0026rsquo;s allocation and proceed to implement the corresponding anesthesia plan accordingly.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec27\" class=\"Section3\"\u003e \u003ch2\u003eAssignment of interventions: Blinding\u003c/h2\u003e \u003cdiv id=\"Sec28\" class=\"Section4\"\u003e \u003ch2\u003eWho will be blinded {17a}\u003c/h2\u003e \u003cp\u003eDue to the nature of the study, blinging of the attending anesthesiologist is not feasible. However, patients, outcome assessors, surgeons and nursing staff will remain blinded until the completion of the study analysis.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec29\" class=\"Section2\"\u003e \u003ch2\u003eProcedure for unblinding if needed {17b}\u003c/h2\u003e \u003cp\u003eWhile we do not anticipate the need for unblinding, if necessary, such as the occurrence of a research-related serious adverse event, the principal investigator or data manager will have access to the group assignment and will report any unblinding promptly.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eData collection and management\u003c/h3\u003e\n\u003cdiv id=\"Sec31\" class=\"Section2\"\u003e \u003ch2\u003ePlans for assessment and collection of outcomes {18a}\u003c/h2\u003e \u003cp\u003eResearch data for this study will be collected from electronic medical records systems or case report forms (CRFs). Preoperative date, including demographics, medical history, medication history, supplementary examinations, and pre-operative assessment, will be completed by pre-operative visitors. The anesthesiologist will record intraoperative date. The QOR-40 scale one day before surgery and postoperative outcomes assessment will be collected by a dedicated assessor. To ensure scientific rigor of our study, all researchers will be trained on how to collect, record and store date before the trial start. All information will be strictly confidential and used solely for research purpose. After data collection, it will be double-entered into Microsoft Excel system and check by two researchers. The principal investigator will conduct a thorough check for any defects in the raw date again. Participants\u0026rsquo; personal information will be kept confidential.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec32\" class=\"Section2\"\u003e \u003ch2\u003ePlans to promote participant retention and complete follow-up {18b}\u003c/h2\u003e \u003cp\u003eDuring the preoperative visit, researchers will provide detailed explanation of the intraoperative management and postoperative follow-up process.\u003c/p\u003e \u003cdiv id=\"Sec33\" class=\"Section3\"\u003e \u003ch2\u003eData management {19}\u003c/h2\u003e \u003cp\u003eAll date will be anonymized, with CRFs abbreviated as initials, and electronic date is coded. Electronic date will be stored on a dedicated computer with double password protection, while paper CRFs will be securely stored in our research center with password-locks. All original documents will be retained for 5 years after the study is completed\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec34\" class=\"Section3\"\u003e \u003ch2\u003eConfidentiality {27}\u003c/h2\u003e \u003cp\u003ePatients will continue to be enrolled until the required number is reached. All date will be anonymized, with CRFs abbreviated as initials, and electronic date is coded. All original documents will only be accessible to researchers with the original ID and password.\u003c/p\u003e \u003cp\u003e \u003cb\u003ePlans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}\u003c/b\u003e \u003c/p\u003e \u003cp\u003eNot applicable. No samples will be collected for this study.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e\n\u003ch3\u003eStatistical methods\u003c/h3\u003e\n\u003cdiv id=\"Sec36\" class=\"Section2\"\u003e \u003ch2\u003eStatistical methods for primary and secondary outcomes {20a}\u003c/h2\u003e \u003cp\u003eAll normally distributed continuous variables will be expressed as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation and analyzed with Student\u0026rsquo;s t-test. For non-normal distributed date, the Mann-Whitney U test will be used, and results will be presented as median and interquartile interval. Categorical variables will be described with frequencies (%) and compared using the chi-square test or Fisher\u0026rsquo;s exact test. A 95% confidence interval (CI) for differences in means (for continuous outcomes) or relative risks (for categorical outcomes) will be calculated. A P-value\u0026thinsp;\u0026lt;\u0026thinsp;0.05 will be considered statistically significant. Statistical analyses will be performed using SPSS software version 26 (IBM, New York, USA).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec37\" class=\"Section2\"\u003e \u003ch2\u003eInterim analyses {21b}\u003c/h2\u003e \u003cp\u003eNo interim analyses will be conducted due to the small number of patients and the expected low incidence of serious adverse events.\u003c/p\u003e \u003cdiv id=\"Sec38\" class=\"Section3\"\u003e \u003ch2\u003eMethods for additional analyses (e.g. subgroup analyses) {20b}\u003c/h2\u003e \u003cp\u003eNo subgroup analyses are planned.\u003c/p\u003e \u003cp\u003e \u003cb\u003eMethods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}\u003c/b\u003e \u003c/p\u003e \u003cp\u003eThe likelihood of missing values in our primary outcome is very low. If missing date occur, multiple imputation techniques will be employed to accurately estimate them.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec39\" class=\"Section2\"\u003e \u003ch2\u003ePlans to give access to the full protocol, participant level-data and statistical code {31c}\u003c/h2\u003e \u003cp\u003eDate sets, statistical codes, and complete protocols analyzed by the institute will be available upon reasonable request to the principal investigator. This approach ensures accuracy, repeatability and promotes further study and cooperation.\u003c/p\u003e \u003cdiv id=\"Sec40\" class=\"Section3\"\u003e \u003ch2\u003eOversight and monitoring\u003c/h2\u003e \u003c/div\u003e \u003c/div\u003e\n\u003ch3\u003eComposition of the coordinating centre and trial steering committee {5d}\u003c/h3\u003e\n\u003cp\u003eThe steering committee, composed of principal investigator, sub- investigator and two clinicians, will guided and supervise the implementation and progress of the trial. Quarterly meetings will be convened to monitor the latest developments in the trial, ensuring that the research design and interpretation of remain relevant to current clinical practice. The committee has the authority to make decisions regarding trial modifications based on specific circumstances and assumes medical responsibility for the patients involved.\u003c/p\u003e\n\u003ch3\u003eComposition of the data monitoring committee, its role and reporting structure {21a}\u003c/h3\u003e\n\u003cp\u003eThis trial is a single-center RCT with relatively small sample size and low intervention risk, and there is no date monitoring committee established. The principal investigator will review all the summarized date, and an independent auditor with expertise will conduct monthly audit. The steering committee will monitor study development quarterly, while the ethics committee will conduct an annual follow-up review.\u003c/p\u003e\n\u003ch3\u003eAdverse event reporting and harms {22}\u003c/h3\u003e\n\u003cp\u003eSAPB, integrated into our multi-mode analgesia approach, will be conducted under precise visual ultrasound guidance and standardized skilled operation. Anesthesia safety will be strictly controlled by experienced anesthesiologists within the team. Any adverse effects or unpredictable complications will be diligently documented and promptly reported to the Ethics Committee as part of our annual report.\u003c/p\u003e\n\u003ch3\u003eFrequency and plans for auditing trial conduct {23}\u003c/h3\u003e\n\u003cp\u003eThere is no Data Monitoring Committee (DMC) established for this study. Instead, an independent auditor with expertise will conduct monthly audits. Additionally, the steering committee and auditor will perform repeated audits every three months to ensure the accuracy and validity of the date. Furthermore, the ethics committee will conduct an annual follow-up review.\u003c/p\u003e\n\u003ch3\u003ePlans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}\u003c/h3\u003e\n\u003cp\u003eAny modifications to the research plan (version 1.0) will be promptly communicated to the principal investigator and the research ethics committee of the second affiliated hospital of army military medical university. A revised plan will be issued following thorough examination and approval.\u003c/p\u003e \u003cp\u003e \u003cb\u003eDissemination plans {31a}\u003c/b\u003e \u003c/p\u003e \u003cp\u003eThe study aims to optimize multi-mode analgesia and enhance ERAS for transapical TAVI, aligning with diagnosis related groups (DRG) in medical management. Results will be disseminated at relevant academic conferences and published in peer-reviewed journals. Both positive and negative findings will be reported.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis single-center, randomized controlled trial aims to investigate the effect of ultrasound-guided SAPB on the early recovery quality and analgesic of patients undergoing transapical TAVI surgery.\u003c/p\u003e \u003cp\u003eTransapical TAVI, a minimally invasive surgical method for aortic valve lesions, offers a promising alternative for elderly and high-risk patients who may be not suitable candidates for traditional surgery. As evidence-based medicine continues to unfold, the indications for TAVI are expanding globally, leading to increased surgical volume and a gradual extension of indications to younger, lower risk and longer life expectancy groups[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. However, perioperative analgesia and postoperative recovery of this minimally invasive cardiac surgery have not received widespread attention. Despite the small incision on transapical TAVI surgery, injuries to the skin and deep tissue, intercostal nerve damage[\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e], postoperative drainage tube stimulation and inflammatory reaction can still lead to severe postoperative pain. The degree of pain is related to postoperative complications and mortality. In addition, many patients undergoing these procedures are frail elderly individuals who are especially susceptible to the hemodynamic fluctuations induced by pain.\u003c/p\u003e \u003cp\u003eAs evidence-based medicine continues to evolve, optimizing postoperative pain management becomes increasingly crucial. A comprehensive and individualized analgesia and rehabilitation program are vital. Perioperative multimodal analgesia, particularly reginal block-based approaches, plays a pivotal role in promoting rehabilitation. It can reduce postoperative acute pain and potential chronic pain by reducing pain sensitization stemming from surgical injury and opioid use. While regional block like epidural analgesia and paraspinal nerve block have shown effectiveness for transapical TAVI, concerns about heparinization-related risks may limit their clinical benefits. SAPB is a fascial plane block with minimal impact on peripheral blood vessels, presents a safer and more maneuverable alternative without sympathetic block[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. To address the gaps in evidence regarding SAPB's effectiveness in acute regional analgesia following minimally invasive cardiac surgery, this trial evaluates the analgesic effect of SAPB in transapical TAVI using measures such as opioid consumption, analgesic pump pressing times, Visual Analog Scale (VAS) pain scores at rest and during coughing, and remedial analgesia time.\u003c/p\u003e \u003cp\u003eDexamethasone, a long-acting synthetic glucocorticoid, is utilized as an adjuvant to LAs to extend their duration[\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e] and mitigate postoperative nausea, vomiting and chills. In our study, we aim to enhance the duration of analgesia and achieve a more pronounced and sustained effect by combining dexamethasone with ropivacaine.\u003c/p\u003e \u003cp\u003ePostoperative recovery quality, a complex and dynamic process, is a critical patient-centered outcome, which can be evaluated from the aspects of physiology, psychology and social adaptation. QOR-40 scale is the best tool to evaluate the quality of early postoperative recovery after clinical intervention based on clinical and research verification. It includes five dimensions: physical comfort, pain, emotional state, physical independence, psychological support. With good validity, reliability, responsiveness and clinical acceptability, QOR-40 is widely used in various perioperative environments[\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. Through this comprehensive assessment, our study aims to provide valuable prospective evidence on regional analgesia efficacy in this population, facilitating optimization of multimodal analgesia and ERAS protocols while enhancing postoperative rehabilitation and medical resource utilization. In conclusion, the findings from this study aim to enrich the existing knowledge base, shedding light on the efficacy of SAPB in transapical TAVI and potentially guiding improvements in clinical practice to bolster patient outcomes.\u003c/p\u003e \u003cp\u003eWe acknoledge some limitations in our study. Firstly, our primary outcome is assessed at 24 and 48 hours postoperatively, providing insights into early recovery but lacking long-term follow-up to evaluate sustained intervention impact and potential complications. In addition, while we explore the effectiveness of SAPB, uncertainty persists regarding the optimal concentration and dosage of LAs and adjuvants in the block. Future high-quality research is warranted to explore this aspect further, elucidating the most effective drug combinations and furnishing instructive insights for clinical practice.\u003c/p\u003e \u003cp\u003e \u003cb\u003eTrial status\u003c/b\u003e \u003c/p\u003e \u003cp\u003eAt the time of manuscript submission, we are conducting this investigation and expect to complete it by January 2025. This is protocol version 1.0, completed on February 24, 2023. Trial recruitment was initiated on March 1, 2023.\u003c/p\u003e \u003cp\u003e \u003cb\u003eAbbreviations\u003c/b\u003e \u003c/p\u003e \u003cp\u003eTAVI Transcatheter aortic valve implantation\u003c/p\u003e \u003cp\u003eERAS Enhanced recovery after surgery\u003c/p\u003e \u003cp\u003eSAPB Serratus Anterior Plane Block\u003c/p\u003e \u003cp\u003eQoR-40 Quality of Recovery-40 scale\u003c/p\u003e \u003cp\u003eVAS Visual analogue score\u003c/p\u003e \u003cp\u003eLAs Local anesthetics\u003c/p\u003e \u003cp\u003ePCIA Patient-controlled intravenous analgesia\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch2\u003eAcknowledgements\u003c/h2\u003e \u003cp\u003eNot applicable.\u003c/p\u003e\u003ch2\u003eAvailability of data and materials\u003c/h2\u003e \u003cp\u003e{29}\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eCribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation 2002, 106(24):3006\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVahanian A, Alfieri OR, Al-Attar N, Antunes MJ, Bax J, Cormier B, Cribier A, De Jaegere P, Fournial G, Kappetein AP, et al. Transcatheter valve implantation for patients with aortic stenosis: a position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur J Cardiothorac Surg. 2008;34(1):1\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWalther T, Falk V, Borger MA, Kempfert J, Ender J, Linke A, Schuler G, Mohr FW. Transapical aortic valve implantation in patients requiring redo surgery. Eur J Cardiothorac Surg. 2009;36(2):231\u0026ndash;4. discussion 234\u0026ndash;235.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBlanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013;68(11):1107\u0026ndash;13.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMayes J, Davison E, Panahi P, Patten D, Eljelani F, Womack J, Varma M. An anatomical evaluation of the serratus anterior plane block. Anaesth 2016, 71(9):1064\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePerez Herrero MA, Lopez Alvarez S, Fadrique Fuentes A, Manzano Lorefice F, Bartolome Bartolome C, Gonzalez de Zarate J. Quality of postoperative recovery after breast surgery. General anaesthesia combined with paravertebral versus serratus-intercostal block. Rev Esp Anestesiol Reanim. 2016;63(10):564\u0026ndash;71.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKim DH, Oh YJ, Lee JG, Ha D, Chang YJ, Kwak HJ. Efficacy of Ultrasound-Guided Serratus Plane Block on Postoperative Quality of Recovery and Analgesia After Video-Assisted Thoracic Surgery: A Randomized, Triple-Blind, Placebo-Controlled Study. Anesth Analg. 2018;126(4):1353\u0026ndash;61.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBerthoud V, Ellouze O, Bievre T, Konstantinou M, Jazayeri S, Bouchot O, Girard C, Bouhemad B. Serratus Anterior Plane Block for Apical TAVR in an Awake Patient. J Cardiothorac Vasc Anesth 2018, 32(5):2275\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePeng L, Ding M, Wei W. Ultrasound-guided serratus anterior plane block for transapical transcatheter aortic valve implantation. J Cardiothorac Surg. 2023;18(1):4.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBerthoud V, Ellouze O, Nguyen M, Konstantinou M, Aho S, Malapert G, Girard C, Guinot PG, Bouchot O, Bouhemad B. Serratus anterior plane block for minimal invasive heart surgery. BMC Anesthesiol. 2018;18(1):144.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGornall BF, Myles PS, Smith CL, Burke JA, Leslie K, Pereira MJ, Bost JE, Kluivers KB, Nilsson UG, Tanaka Y, et al. Measurement of quality of recovery using the QoR-40: a quantitative systematic review. Br J Anaesth. 2013;111(2):161\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGuimaraes-Pereira L, Costa M, Sousa G, Abelha F. [Quality of recovery after anaesthesia measured with QoR-40: a prospective observational study]. Rev Bras Anestesiol. 2016;66(4):369\u0026ndash;75.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMyles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000;84(1):11\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRusso M, Corcione N, Cammardella AG, Ranocchi F, Lio A, Saitto G, Nicolo F, Pergolini A, Polizzi V, Ferraro P, et al. Transcatheter aortic valve implantation in patients with age =70 years: experience from two leading structural heart disease centers\u0026lt;/at. Minerva Cardiol Angiol. 2023;71(3):324\u0026ndash;32.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAncona MB, Toscano E, Moroni F, Ferri LA, Russo F, Bellini B, Sorropago A, Mula C, Festorazzi C, Gamardella M, et al. Patients younger than 70 undergoing transcatheter aortic valve implantation: Procedural outcomes and mid-term survival. Int J Cardiol Heart Vasc. 2021;34:100817.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFont MC, Navarro-Martinez J, Nadal SB, Munoz CG, Galiana-Ivars M, Montero PC. Continuous Analgesia Using a Multi-Holed Catheter in Serratus Plane for Thoracic Surgery. Pain Physician. 2016;19(4):E684\u0026ndash;685.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYu S, Valencia MB, Roques V, Aljure OD. Regional analgesia for minimally invasive cardiac surgery. J Card Surg. 2019;34(11):1289\u0026ndash;96.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKrom RJ, Welsby IJ, Fuller M, Barbas AS, Gao Q, Anwar IJ, Dunkman WJ. Incidence of Postreperfusion Hyperfibrinolysis in Liver Transplantation by Donor Type and Observed Treatment Strategies. Anesth Analg. 2023;136(3):518\u0026ndash;23.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWu CL, Cho B, Gabriel R, Hurley R, Liu J, Mariano ER, Mathur V, Memtsoudis SG, Grant MC. Addition of dexamethasone to prolong peripheral nerve blocks: a ChatGPT-created narrative review. Reg Anesth Pain Med; 2023.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGuimaraes-Pereira L, Costa M, Sousa G, Abelha F. Quality of recovery after anaesthesia measured with QoR-40: a prospective observational study. Braz J Anesthesiol. 2016;66(4):369\u0026ndash;75.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Serratus anterior plane block, Transcatheter aortic valve implantation, Postoperative recovery quality, Analgesia","lastPublishedDoi":"10.21203/rs.3.rs-3917241/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3917241/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eCompared to traditional thoracotomy, transapical transcatheter aortic valve implantation (TAVI) surgery offers reduced trauma and faster recovery, fostering the adoption of enhanced recovery after surgery (ERAS) protocols in cardiac surgery. Despite these advancements, postoperative pain management has received insufficient attention. The potential effects of multi-mode analgesia, including ultrasound-guided serratus anterior plane block (SAPB), on postoperative pain and early quality of recovery have not been widely studied, lacking comprehensive prospective evidence. Therefore, this study aims to investigate the impact of SAPB combined with general anesthesia on early recovery quality and analgesic efficacy in transapical TAVI patients.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThis prospective, randomized controlled study will enroll 70 patients undergoing transapical TAVI, randomly allocated to either the SAPB group or the control group. The primary outcome, assessed using quality of recovery-40 (QOR-40) scale, focuses on the quality of recovery at 24 h and 48 h postoperatively. Secondary outcomes include the visual analog scale (VAS) pain scores at rest and during coughing at 6 h, 12 h, 24 h, and 48 h after surgery, frequency of patient-controlled analgesia (PCA) utilization at 24 h and 48 h, opioid consumption at 24 h and 48 h, time and frequency of rescue analgesia and severe pain at 24 h and 48 h, incidence of nausea and vomiting at 48 h after surgery and dosage of antiemetic drugs.\u003c/p\u003e\u003ch2\u003eDiscussion\u003c/h2\u003e \u003cp\u003eThe purpose of our study is to evaluate the effects of ultrasound-guided SAPB combined with general anesthesia on postoperative early quality of recovery and analgesia in transapical TAVI patients. The results obtained may provide valuable insight for the implementation of multi-mode analgesia and enhanced ERAS in this specific patient population.\u003c/p\u003e\u003ch2\u003eTrial registration\u003c/h2\u003e \u003cp\u003eChina Clinical Trial Register ChiCTR2300068584. 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