Randomized Trial of Esketamine Infusion for Treating Chronic Pelvic Pain in Women with Endometriosis

What this Trial Is About

The trial investigates chronic pelvic pain caused by endometriosis, a chronic inflammatory condition affecting about 10% of women of reproductive age. This disease often leads to severe pain, reduced quality of life, depression, and economic impact. The study aims to assess how esketamine, a drug with pain-relieving, anti-inflammatory, and antidepressant properties, compares to placebo in treating this chronic pain through a randomized controlled design. Participants will receive either an esketamine infusion or a placebo saline infusion. The esketamine dosing begins at 0.1 mgkgh and may be increased gradually every few hours over an 8-hour period up to a maximum of 0.5 mgkgh based on monitored vital signs and side effects. The placebo group will receive an 8-hour saline infusion. This treatment phase is followed by scheduled assessments to evaluate the effects. Participants will be monitored for pain levels, side effects, quality of life, depressive symptoms, and pain coping ability before and after treatment. Assessments occur at baseline and at multiple time points up to 12 weeks after infusion, including evaluations of pelvic pain, menstrual pain, urinary and bowel pain, depressive symptoms, and overall quality of life. Safety and treatment experiences are also recorded during and immediately after infusion. The total study duration includes follow-up visits to track ongoing effects and costs related to productivity and medical care.

Esketamine as Treatment for Chronic Pain Due to Endometriosis: a RCT Study