A Randomized Controlled Trial Comparing the Efficacy of Bupivacaine Injection in Vaginal Vault and Paracervical Region Versus Vaginal Vault Infiltration with Bupivacaine After Total Laparoscopic Hysterectomy.

Background Demand for laparoscopic surgeries have been on the rise in all surgical departments in the past few decades. Hysterectomy, one of the most common gynaecological procedures is preferred laparoscopically these days owing to their multiple benefits. Aim To compare the efficacy and safety of Bupivacaine injection in Vault versus Paracervical Block and Vault Infiltration with Bupivacaine after Total Laparoscopic Hysterectomy.

Thirty women undergoing total laparoscopic hysterectomy for benign gynaecology conditions were recruited and randomised into two comparable groups. Group I had 15 patients who received vaginal vault infiltration with 10 ml of 0.5% Bupivacaine. Group II had 15 patients who received paracervical block before surgery and vaginal vault infiltration after vault closure with 10 ml of 0.5% Bupivacaine. All patients were treated with injection paracetamol and NSAIDS. VAS score and need for additional analgesia were recorded at 1 h, 2 h and 6 h post-surgery. Any patient who reported a VAS score of more than 4 were given injection tramadol as rescue analgesia and recorded.

All the baseline characteristics were comparable except dysmenorrhoea (P = 0.017) and BMI (0.034) which showed statistically significant difference between the two groups. The VAS scores were significantly lower in combined group (Group I) when compared with vault infiltration group (Group II) across all time points (P− < 0.001). The need for rescue analgesia at 1-h post-surgery was lower in both the groups and comparable among the two groups (P = 0.483). The need for rescue analgesia at 2 h {P− < 0.001} and 6 h post-surgery {P− < 0.001} were significantly lesser in Group II (combined group). No patients required additional analgesia in group II.

Two novel methods of administering local anaesthetic to alleviate post TLH pain when used in conjunction can significantly reduce pain and analgesia requirements making shorter hospital stay and early return to daily activities possible hence reducing cost per procedure.

Hysterectomy, Paracervical block, Bupivacaine, Additional analgesia

Hysterectomy is one of the most commonly performed gynaecological surgeries. The use of minimally invasive surgical techniques has been on the rise owing to its added benefits such as lesser blood loss, lesser postoperative pain, cosmesis and early resumption to daily activities [1]. Vaginal hysterectomy and laparoscopic hysterectomy are included as minimally invasive methods of hysterectomy. Laparoscopic hysterectomy is the most preferred method of hysterectomy when vaginal hysterectomy is not indicated or suitable [2]. Systematic review of many studies comparing total laparoscopic hysterectomy (TLH) and Abdominal hysterectomy shows that, patients undergoing laparoscopic hysterectomy returned to their daily activities much earlier than patients undergoing total abdominal hysterectomy [3]. Various analgesic interventions in use after Total Laparoscopic Hysterectomy (TLH) are Non-steroidal Anti-Inflammatory Drugs (NSAIDS), steroids, gabapentinoids, opioids, epidural analgesia, Transverse Abdominis plane (TAP) block, intraperitoneal local anaesthetics, port site infiltration, etc. The usage of local anaesthetics has been of clinical interest in recent times due to its lower systemic side effects, feasibility and ease of administration. Local anaesthetic agents have been administered as port site infiltration, intra peritoneal instillation, paracervical block, TAP block and vaginal vault infiltration. After extensive review of literature on the role of Bupivacaine as postoperative Analgesia after TLH, there is enough evidence to prove both paracervical block and vault infiltration have significant efficacy in reducing post TLH pain [4]. In this study, our aim is to compare additional benefit of paracervical block in addition to vaginal vault infiltration with bupivacaine after total laparoscopic hysterectomy.

Study Design: Prospective two-armed double blinded Randomized Comparative Trial. Total number of patients recruited were thirty. Patients were randomly allocated in two groups. Group I: Fifteen in number, received vault infiltration with Bupivacaine after TLH. Group II: Fifteen in number, received Bupivacaine paracervical block before TLH and infiltration to vaginal vault after TLH. Inclusion criteria: Women aged 25–65 years, undergoing total laparoscopic hysterectomy for benign conditions, acceptable concomitant procedures like salpingectomy or salpingo oophorectomy. Exclusion criteria: Procedures like—pelvic lymph node dissection, Sacro colpopexy, anterior / posterior colporrhaphy, sling surgeries, deep infiltrating endometrioses and undue prolonged surgeries, Women undergoing hysterectomy for gynaecological malignancies, Conversion to laparotomy, Difficulty in administering paracervical block due to anatomic abnormalities, history of chronic pelvic inflammatory diseases, previous multiple abdominal or pelvic surgeries, known allergy to amide anaesthetics, injury to gastrointestinal or urinary tract intraoperatively. Patients were placed in the lithotomy position for the standardized laparoscopic procedure after administration of general anaesthesia. Paracervical injection with 10 ml of 0.5% Bupivacaine administered into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm before fixation of uterine manipulator onto the cervix to group II individuals. Care was taken to prevent inadvertent injection into blood vessels by aspirating before injection of the anaesthetic agent. A uterine manipulator was inserted. Pneumoperitoneum was created using a Veress needle through the umbilicus, and a 10 mm umbilical trocar was inserted for primary port. Two 5 mm secondary ports using trocars was inserted in the left and one secondary port inserted in the right under direct visualization. TLH was performed stepwise using Ligasure and Harmonic scalpel as energy sources (placed at low power settings), long desiccation time was avoided to minimize the production of fumes. The vaginal cuff was closed using a continuous barb suture laparoscopically. The vaginal vault was infiltrated with 10 ml 0.5% Bupivacaine at 3–4 mm deep laparoscopically through a 5 mm port using fine tipped aspiration needles in the group I and II. No abdominal drains were used. Postoperative pain was treated using intravenous paracetamol 1 g /6th hourly for 24 h and injectable NSAIDs. If there was any need for further requirement of opioid analgesics in any patient it was recorded. The severity of incisional pain using VAS score (0 indicated no pain, and 10 indicated unbearable pain) at 1 h, 2 h and 6 h after surgery was recorded. Any patient reporting VAS of more than 4 received injection tramadol and was recorded promptly. The half-life of Bupivacaine is 2.7 h, whereas the mean duration of total laparoscopic hysterectomy was 98–159 min. Hence a cumulative effect of paracervical block given at the beginning of the surgery and vaginal vault infiltration given at the end of the surgery is expected. The operative time, amount of operative bleeding, size of uterus and any complications were recorded (Fig. 1). Statistical Analysis Data was tested for normality assumption using appropriate statistical tests. Descriptive statistics such as SD and range values were computed for normally distributed data and mean value were compared using “t independent” tests. Frequency of categorical data were compared using “chi square/Fischer exact” tests. Non- normal data, median values and inter quartile range were computed using non- parametric “Mann Whitney tests”. All statistical analysis were carried out using STATA software version 12.0. All statistical tests with two tailed probabilities of P < 0.05 were considered as statistically significant. According to an earlier study by Hristovska in 2013, the mean (± standard deviation) of VAS score at 1 h between treatment and control group was (6 ± 2) and (7 ± 2) respectively. Assuming similar observation for present study, the expected calculated coefficient between 1 and 2 h is 0.2, according to that the adequate sample size for power of study at 80% and 5% level of significance was 40 per group [5]. However due to constraints of time and availability of patients according to inclusion and exclusion criteria and the ongoing pandemic, it was decided to have 15 patients in each group.

There was no significant difference between the groups in terms of Age (Years) (t = − 0.206, P = 0.839). Strength of Association = 0.04 (Little/No Association) (Table 1) There was no significant difference between the various groups in terms of distribution of Educational Status, Occupation, except Dysmenorrhea and BMI (Table 2). There was no significant difference between the groups in terms of PBAC-P = 0.693 Strength of Association = 0.07 (Little/No Association). (Table 3). There was no significant difference between the various groups in terms of distribution of Parity, comorbidities and Indication (Table 4). There was no significant difference between the various groups in terms of distribution of Surgery and uterus size (Table 5). There was no significant difference between the groups in terms of Operative Time (Minutes) and Blood Loss (cc). (Table 6). There was a significant difference between the 2 groups in terms of VAS (1 h) VAS (2 h). There was a significant difference between the 2 groups in terms of VAS (6 h) (Table 7). There was no significant difference between the various groups in terms of distribution of Required Analgesia (1 h)—P = 0.483. There was a significant difference between the various groups in terms of distribution of Required Analgesia (2 h). There was a significant difference between the various groups in terms of distribution of Required Analgesia (6 h)—p = < 0.001. Strength of association between the two variables = 0.94 (High Association). (Table 8). The following table summarizes the mean change in VAS from the 1 Hour time point to the various follow-up time points. It also summarizes the statistical comparison of the two groups in terms of this difference (Table 9). The following table summarizes the mean percent change in VAS from the one hour time point to the various follow-up time points. It also summarizes the statistical comparison of the two groups in terms of this difference (Table 10). Table 1. | Age (years) | Group | t-test | || |---|---|---|---|---| | 1 | 2 | T | P value | | | Mean (SD) | 44.73 (5.96) | 45.33 (9.58) | − 0.206 | 0.839 | | Median (IQR) | 44 (41–47) | 45 (43.5–47.5) | || | Range | 35–58 | 25–68 | Table 2. | Group | Chi-squared test | |||| |---|---|---|---|---|---| | 1 | 2 | Total | χ2 | P value | | | Educational status | ||||| | Non-graduate | 9 (60.0%) | 10 (66.7%) | 19 (63.3%) | 0.144 | 0.705 | | Graduate | 6 (40.0%) | 5 (33.3%) | 11 (36.7%) | || | Occupation | ||||| | Home maker | 13 (86.7%) | 13 (86.7%) | 26 (86.7%) | 0.000 | 1.000 | | Skilled worker | 2 (13.3%) | 2 (13.3%) | 4 (13.3%) | || | Dysmenorrhea (Yes) | 15 (100.0%) | 9 (60.0%) | 24 (80.0%) | 7.500 | 0.017 | | BMI | 15 (100.0%) | 15 (100.0%) | 30 (100.0%) | 9.889 | 0.034 | Table 3. | PBAC | Group | Wilcoxon–Mann–Whitney U test | || |---|---|---|---|---| | 1 | 2 | W | P value | | | Mean (SD) | 573.67 (316.06) | 517.67 (480.86) | 122.500 | 0.693 | | Median (IQR) | 625 (412.5–765) | 220 (110–1025) | || | Range | 90–1100 | 90–1320 | Table 4. | Parity | Group | Fisher's exact test | ||| |---|---|---|---|---|---| | 1 | 2 | Total | χ2 | P value | | | P0 | 0 (0.0%) | 1 (6.7%) | 1 (3.3%) | 4.485 | 0.223 | | P1 | 5 (33.3%) | 1 (6.7%) | 6 (20.0%) | || | P2 | 6 (40.0%) | 6 (40.0%) | 12 (40.0%) | || | ≥ P3 | 4 (26.7%) | 7 (46.7%) | 11 (36.7%) | || | Total | 15 (100.0%) | 15 (100.0%) | 30 (100.0%) | || | Comorbidities | ||||| | Diabetic | 3 (20.0%) | 1 (6.7%) | 4 (13.3%) | 1.900 | 0.677 | | HTN | 3 (20.0%) | 5 (33.3%) | 8 (26.7%) | || | Hypothyroid | 2 (13.3%) | 1 (6.7%) | 3 (10.0%) | || | None | 7 (46.7%) | 8 (53.3%) | 15 (50.0%) | || | Total | 15 (100.0%) | 15 (100.0%) | 30 (100.0%) | || | Diabetic | 3 (20.0%) | 1 (6.7%) | 4 (13.3%) | || | HTN | 3 (20.0%) | 5 (33.3%) | 8 (26.7%) | || | Indication | ||||| | AUB-A | 3 (20.0%) | 8 (53.3%) | 11 (36.7%) | 5.396 | 0.136 | | AUB-L | 3 (20.0%) | 2 (13.3%) | 5 (16.7%) | || | AUB-M | 9 (60.0%) | 4 (26.7%) | 13 (43.3%) | || | CIN | 0 (0.0%) | 1 (6.7%) | 1 (3.3%) | || | Total | 15 (100.0%) | 15 (100.0%) | 30 (100.0%) | Table 5. | Surgery | Group | Fisher's exact test | ||| |---|---|---|---|---|---| | 1 | 2 | Total | χ2 | P value | | | TLH | 3 (20.0%) | 5 (33.3%) | 8 (26.7%) | 0.786 | 0.892 | | TLH + BS | 4 (26.7%) | 4 (26.7%) | 8 (26.7%) | || | TLH + BSO | 8 (53.3%) | 6 (40.0%) | 14 (46.7%) | || | Total | 15 (100.0%) | 15 (100.0%) | 30 (100.0%) | || | Uterus size | ||||| | Normal size | 4 (26.7%) | 3 (20.0%) | 7 (23.3%) | 5.810 | 0.488 | | Bulky | 4 (26.7%) | 8 (53.3%) | 12 (40.0%) | || | 6 To 8 weeks | 1 (6.7%) | 1 (6.7%) | 2 (6.7%) | || | 10 to 12 weeks | 1 (6.7%) | 0 (0.0%) | 1 (3.3%) | || | 12 to 14 weeks | 1 (6.7%) | 1 (6.7%) | 2 (6.7%) | || | 14 to 16 weeks | 1 (6.7%) | 2 (13.3%) | 3 (10.0%) | || | > 16 weeks | 3 (20.0%) | 0 (0.0%) | 3 (10.0%) | Table 6. | Operative time (min) | Group | Wilcoxon–Mann–Whitney U test | || |---|---|---|---|---| | 1 | 2 | W | P value | | | Mean (SD) | 66.33 (20.66) | 57.00 (12.93) | 139.000 | 0.256 | | Median (IQR) | 60 (45–82.5) | 60 (45–60) | || | Range | 45–100 | 45–90 | || | Blood loss (cc) | |||| | Mean (SD) | 64.00 (32.03) | 51.67 (21.02) | 141.500 | 0.228 | | Median (IQR) | 80 (30–90) | 50 (40–67.5) | || | Range | 10—100 | 10—80 | Table 7. | Group | Wilcoxon–Mann–Whitney U test | ||| |---|---|---|---|---| | 1 | 2 | W | P value | | | VAS (1 h) | |||| | Mean (SD) | 3.67 (0.72) | 1.20 (0.41) | 225.000 | < 0.001 | | Median (IQR) | 4 (3–4) | 1 (1–1) | || | Range | 3–5 | 1–2 | || | VAS (2 h) | |||| | Mean (SD) | 6.13 (1.41) | 2.07 (0.46) | 10.642 | < 0.001 | | Median (IQR) | 6 (5.5–7) | 2 (2–2) | || | Range | 4–8 | 1–3 | || | VAS (6 h) | |||| | Mean (SD) | 7.93 (1.39) | 3.13 (0.52) | 223.500 | < 0.001 | | Median (IQR) | 8 (8–8.5) | 3 (3–3) | || | Range | 4–10 | 2–4 | Table 8. | Group | Fisher's exact test | |||| |---|---|---|---|---|---| | 1 | 2 | Total | χ2 | P value | | | Required analgesia (1 h) | ||||| | Yes | 2 (13.3%) | 0 (0.0%) | 2 (6.7%) | 2.143 | 0.483 | | No | 13 (86.7%) | 15 (100.0%) | 28 (93.3%) | || | Required analgesia (2 h) | ||||| | Yes | 11 (73.3%) | 0 (0.0%) | 11 (36.7%) | 17.36 8 | < 0.001 | | No | 4 (26.7%) | 15 (100.0%) | 19 (63.3%) | || | Required analgesia (6 h) | ||||| | Yes | 14 (93.3%) | 0 (0.0%) | 14 (46.7%) | 26.250 | < 0.001 | | No | 1 (6.7%) | 15 (100.0%) | 16 (53.3%) | Table 9. | Time point comparison | Change in VAS from 1 h to follow-up time points | P value | ||| |---|---|---|---|---|---| | Group: 1 | Group: 2 | |||| | Mean (SD) of absolute change | P value of change within group | Mean (SD) of absolute change | P value of change within group | || | 2–1 H | 2.47 (1.36) | 0.010 | 0.87 (0.64) | 0.046 | 0.002 | | 6–1 H | 4.27 (1.39) | < 0.001 | 1.93 (0.59) | < 0.001 | < 0.001 | Table 10. | Time point comparison | Percent change in VAS from 1 h to follow-up time points | P value | ||| |---|---|---|---|---|---| | Group: 1 | Group: 2 | |||| | Mean (SD) of percent change | P value of change within group | Mean (SD) of percent change | P value of change within group | || | 2–1 h | 0.9% (42.4) | 0.010 | 86.7% (55.0) | 0.046 | 0.290 | | 6–1 h | 121.9% (51.4) | < 0.001 | 180.0% (75.1) | < 0.001 | 0.016 | Post-Hoc pairwise tests for Friedman test performed using Nemenyi test were used to explore the statistical significance of the change in VAS from the 1 h time point to the various follow-up time points. Group comparisons for change in VAS performed using Wilcoxon–Mann–Whitney Test. Green background denotes statistically significant difference at p < 0.05 In this study 30 women undergoing total laparoscopic hysterectomy were randomized using computer generated program. Group 1 included 15 patients who received vault infiltration with bupivacaine after total laparoscopic hysterectomy. Group 2 included 15 patients who received bupivacaine paracervical block before TLH and bupivacaine infiltration to vaginal vault after TLH. Baseline characteristics were comparable across both the groups like age, educational status, occupation and parity. Most common indication for TLH was seen to be AUB—M (43%) followed by AUB—A(36%) in both the groups. Most common procedure performed was TLH + BSO (46%). The difference between mean values of estimated blood loss and operating time were not statistically significant in both the groups (P > 0.005). The baseline characteristics and operative characteristics are shown in table. All subjects in Group 2 had VAS score of 4 or less than 4 at 1, 2- and 6-h post TLH. No patient needed rescue analgesia in group 2 at 1, 2 and 6-h post-surgery. There was a significance difference between the two groups in terms of VAS at 1 h, 2 h and at 6 h post TLH (P = < 0.001) with median VAS at 1 h being higher in group 1. The strength of association seems to be 0.9 thus a large effect size. There was no significant difference between the various groups in terms of distribution of required analgesia at 1-h post-surgery (P = 0.483). It was seen 13.3% of the participants in the group 1 required additional analgesia at 1 h of surgery compared to 0% of participants in group 2. There was a significant difference between the various groups in terms of distribution of required analgesia at 2 h and 6 h post TLH (P = < 0.001). Results show that 73.3% of participants in group 1 at 2 h and 93.3% of participants in group 1 at 6 h post TLH required analgesia compared to 0% in group 2 at 2 and 6-h post- surgery. There was a significant difference in the trend of VAS over time between the two groups (P = < 0.001).

Vanessa Bacal et al. [6] performed a systematic review on the pain scores after TAP block in women undergoing elective hysterectomy (Both TLH and abdominal hysterectomy). Mean VAS scores and need for opioid analgesia were recorded at 2 h and 24 h following surgery. In our study VAS scores were recorded at 1 h, 2 h and 6 h post-surgery. Results showed that VAS score and rescue analgesia requirement were comparable at 2 h post-surgery. Similarly in our study analgesia requirement at 1-h post-surgery was comparable in both the groups. At post 24 h of surgery pain scores were significantly lower in both abdominal hysterectomy and TLH patients when compared with control group (placebo or no block). Barr Grzesh [7] conducted a randomized, double-blind, placebo-controlled, parallel- group trial to study the effect of paracervical block of Bupivacaine mixed with epinephrine before supracervical laparoscopic hysterectomy in reducing postoperative pain. Number of days of admission, VAS score post-surgery, and requirement of rescue analgesia were noted. VAS score at 1, 2 and 4 h and 1 and 2 days after surgery were studied, whereas in our study only till 6 h were recorded. Study population consisted of 132 patients—68 in the intervention group and 64 in the control group. Intervention group patients received 20 ml of paracervical injection of 0.25% bupivacaine with epinephrine and in our study 10 ml of 0.5% Bupivacaine was administered. Control group patients received 20 ml of normal saline before skin incision. In intervention group 34% of patients and 27% in the control group needed more than one day of admission. Need for opioid analgesics were more in control group compared to intervention group. Pain scores in both the groups were comparable in this study as opposed to P < 0.001 in our comparative trial. Noor et al. [8] conducted a prospective, randomized, double blinded, placebo-controlled study to assess 0.5% bupivacaine as paracervical block in reducing post total laparoscopic hysterectomy pain. Total study population included 60 women undergoing total laparoscopic hysterectomy, thirty in treatment group and thirty in control group. Patients in intervention group received 10 ml of 0.5% bupivacaine as paracervical block. The controlled group received 10 ml of normal saline in the paracervical region. Pain scores at 30 min and 60 min post-surgery were recorded. Rescue opioid analgesia requirement, duration of stay in hospital and need for readmission were noted. Pain scores were considerably lower in treatment group both at 30 min and 60 min. Olga Kilpio [9] conducted a single centre randomized trial to study the efficacy of ropivacaine infiltration to vaginal cuff on pain after laparoscopic hysterectomy. Study population included 81 women of reproductive age undergoing laparoscopic hysterectomy for benign conditions. Patients in intervention group (41 women) were administered 10 ml of ropivacaine at four points in vaginal cuff and in the trocar site and 40 women in the control group received only trocar site infiltrations of the same local Anesthetic. In our study 10 ml of 0.5% Bupivacaine injection in vaginal vault administered laparoscopically after closure of vault. Visual analog score of postoperative pain, requirement of opioid analgesia, time till discharge, side effects and complications were shown. Patients reporting VAS of < 3 were more in intervention group compared with control group. The requirement of opioid analgesia, duration of hospital stay and other studied parameters were comparable. Our study’s main aim was to compare postoperative pain scores and requirement of rescue analgesia among group I which received vaginal vault infiltration alone and group II which received both paracervical block and vaginal vault infiltration with Bupivacaine. It was seen that VAS scores were significantly lower in group II on comparison with group I at 1st, 2nd and 6th hour post-surgery. Mean VAS score at 1st hour post-surgery was 3.67 in Vault infiltration group vs 1.2 in Paracervical block and vault infiltration group (P− < 0.001). Mean VAS score at 2nd hour post-surgery was 6.13 in Vault infiltration group vs 2.07 in Paracervical block and vault infiltration group (P− < 0.001). Mean VAS score at 6th hour post-surgery was 7.93 in Vault infiltration group vs 3.13 in Paracervical block and vault infiltration group (P− < 0.001). No patient in group II required rescue analgesia in group II (paracervical block + vault infiltration), whereas 13.3% at 1st hour, 73.3% at 2nd hour and 93.3% at 3rd hour post-surgery required additional analgesia (P − < 0.001).

This prospective two-armed double blinded randomized comparative trial which compared vaginal vault infiltration vs paracervical block and vaginal vault infiltration with Bupivacaine in controlling postoperative pain after total laparoscopic hysterectomy show that paracervical block with vaginal vault infiltration group had significantly lower pain scores at 1st, 2nd and 6th hour post-surgery and significantly lesser ( virtually nil) need for rescue analgesia in the immediate postoperative period till 6 h after surgery. Thus, in conclusion these two novel methods of administering local anaesthetic to alleviate post TLH pain when used in conjunction can significantly reduce pain and analgesia requirements making shorter hospital stay and early return to daily activities possible hence reducing cost per procedure.

The authors thank all the anonymous reviewers and editors for their suggestions, which will be helpful for us to improve our paper. We did not use any third-party writers or AI for manuscript. Funding None. Declarations Conflict of interest The authors declare no competing interests. Ethical approval This study was conducted in accordance with the ethical standards of AIIMS Ethics, Institutional Review Board. Informed consent Informed consent was obtained from all participants involved in the study. Participants were provided with detailed information regarding the purpose of the research, procedures, risks, and benefits, and their right to withdraw at any time. Footnotes K. S. Kaloni, Junior Resident; K. K. Roy, Ex Professor; Deepali Garg, MS, Associate Professor; Avir Sarkar, Assistant Professor, Noida International Institute of Medical Sciences, Noida, Uttar Pradesh; Rinchen Zangmo, Senior Clinical Fellow; Anshul Kulshreshtha, Senior Resident. Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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