Esketamine infusion as treatment for chronic endometriosis-associated pain? Study protocol for a randomized controlled trial (EASYlight-study)

Rozemarijn de Koning, Albert Dahan, Jeroen Metzemaekers, Jurjan van Cosburgh, M. Elske van den Akker‐van Marle, Frank Willem Jansen, Mathijs D. Blikkendaal, Andries R. H. Twijnstra
In: Journal of Endometriosis and Pelvic Pain Disorders · 2024 · vol. 17(1) , pp. 49–56 · doi:10.1177/22840265241302377 · W4405140934
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This double-blinded RCT will assess the efficacy of an 8-hour esketamine infusion versus placebo in reducing chronic endometriosis-associated pain in premenopausal women.

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This study protocol outlines a double-blinded randomized controlled trial designed to evaluate the efficacy of esketamine infusion for managing chronic endometriosis-associated pain. The research will enroll 56 premenopausal women aged 18 or older who have been diagnosed with endometriosis, including peritoneal, ovarian, deep infiltrating, or adenomyosis cases, and who suffer from chronic pelvic pain with a numeric rating scale score of at least six. Participants will receive either an eight-hour esketamine infusion or a saline placebo, with outcomes measured through digital questionnaires assessing pain scores, quality of life, depressive symptoms, and healthcare utilization over a 12-week follow-up period. This paper is centrally about endometriosis — specifically investigating a novel pharmacological intervention for pain management in patients with endometriosis and adenomyosis.

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Abstract

Current treatment options for chronic endometriosis-associated pain are often inadequate, resulting in a rise in opioid consumption in this population. Given its analgesic, anti-inflammatory, and anti-depressive properties, esketamine may be a promising alternative treatment option. While esketamine is globally used in the treatment of chronic pain conditions, no clinical trials have been conducted to investigate the efficacy of esketamine infusion to alleviate chronic endometriosis-associated (pelvic) pain. Therefore, the objective of this double-blinded randomized controlled trial (RCT) is to assess the efficacy of 8-h infusion with esketamine versus placebo (saline) to reduce chronic endometriosis-associated pain symptoms. Secondary study objectives include pain scores, quality of life, depressive symptoms, health care utilization, productivity loss, cost-effectiveness, side effects, treatment experience, and pain coping and cognition. Premenopausal women (aged ⩾18 years) diagnosed with endometriosis (peritoneal, ovarian, deep, or adenomyosis), with an indication for laparoscopic endometriosis resection surgery and who suffer from chronic pelvic pain (NRS score ⩾6) will be eligible for inclusion. In total, we aim to include 56 participants, with a follow-up of 12 weeks. Digital questionnaires will be sent at baseline and 4, 8, and 12 weeks after the day of infusion. Trial registration number The EASYlight study is registered as “EASYlight-NEK” in the Clinical Trials Register (NCT06161805)
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Esketamine infusion as treatment for chronic endometriosis-associated pain? Study protocol for a randomized controlled trial (EASYlight-study) Abstract Current treatment options for chronic endometriosis-associated pain are often inadequate, resulting in a rise in opioid consumption in this population. Given its analgesic, anti-inflammatory, and anti-depressive properties, esketamine may be a promising alternative treatment option. While esketamine is globally used in the treatment of chronic pain conditions, no clinical trials have been conducted to investigate the efficacy of esketamine infusion to alleviate chronic endometriosis-associated (pelvic) pain. Therefore, the objective of this double-blinded randomized controlled trial (RCT) is to assess the efficacy of 8-h infusion with esketamine versus placebo (saline) to reduce chronic endometriosis-associated pain symptoms. Secondary study objectives include pain scores, quality of life, depressive symptoms, health care utilization, productivity loss, cost-effectiveness, side effects, treatment experience, and pain coping and cognition. Premenopausal women (aged ⩾18 years) diagnosed with endometriosis (peritoneal, ovarian, deep, or adenomyosis), with an indication for laparoscopic endometriosis resection surgery and who suffer from chronic pelvic pain (NRS score ⩾6) will be eligible for inclusion. In total, we aim to include 56 participants, with a follow-up of 12 weeks. Digital questionnaires will be sent at baseline and 4, 8, and 12 weeks after the day of infusion. Trial registration numberThe EASYlight study is registered as “EASYlight-NEK” in the Clinical Trials Register (NCT06161805)

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Outcome instruments

NRS-pain

Condition tags

endometriosisadenomyosischronic_pelvic_pain

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Papers in the corpus that this work cites (lower rings, blue) and that cite this one (upper rings, green). Dot size scales with the paper's in-corpus citation count — bigger dot = more influential within the endo/adeno field. Click a dot to open that paper. [ expand to 2 hops ] — adds papers reached through this work's immediate citers/citees. Heavier; up to 60 extra dots.

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