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)