Esketamine as Treatment for Chronic Pain Due to Endometriosis: a RCT Study
The goal of this randomized controlled trial is to investigate the effect of esketamine versus placebo on the NRS score for chronic pelvic pain. Secondary endpoints are to assess pain scores, side-effects, quality of life, depressive symptoms and pain coping.
• Women
• All pre-menopausal women aged above 18 years
• Diagnosed with endometriosis (ultrasound, MRI or previous laparoscopic and/or diagnostic surgery) according to the #Enzian classification \[52\]. This means that endometriosis is present in the following compartments:
‣ Rectovaginal space (minimal A1) and/or
⁃ Sacrouterine ligaments, cardinal ligaments, pelvic sidewall (minimal B1) and/or
⁃ Rectum (minimal C1) and/or
⁃ Endometriosis of the intestines, diaphragm and/or
⁃ Adenomyosis (according to the morphological uterus sonographic assessment (MUSA) or evident adenomyosis on the MRI) \[53, 54\] and/or
⁃ Peritoneal / superficial endometriosis (diagnosed laparoscopically and not treated during surgery).
• Mild to severe chronic pelvic pain (NRS scale \>= 6). The 11-point NRS scale ranges from '0' representing no pain to '10' representing the worst pain imaginable.
• Resistant to current recommended lines of analgesics (paracetamol, NSAIDs)
• Usage of strong opioids must not have been prescribed or otherwise have been discontinued for more than 1 week.
• An indication for endometriosis resection surgery or on the waiting list for surgical treatment
• Ability to understand the patient information letter and to give oral and written informed consent
• No alteration in the utilization of hormonal therapy ≤1 months prior to inclusion.