RecruitingPhase 3NCT06161805

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

Sponsor

Reinier de Graaf Groep

Enrollment

56 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Pelvic Pain Syndrome Endometriosis

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria15

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.

Exclusion Criteria23

Pain score \<6 out of 10 (NRS) for chronic pelvic pain
Endometriosis affecting the bladder and ureter
Increased intracranial pressure
Poorly regulated hypertension, \>180/100mmHg at rest
Patients with thyroid disease
Patients with cancer
History of psychiatric illness (schizophrenia, psychosis, delirium, manic depression)
Serious medical disease (e.g., cardiovascular, renal , pulmonary or liver disease)
Severe liver disease
Patients with glaucoma
Usage of strong opioid medication
Usage of xanthine derivatives or ergometrine
Unstable angina, heart failure, history of cerebral vascular accident (CVA)
Patients suffering from an active infection
Patients with epilepsy
Patients trying to achieve pregnancy and or patients who are breastfeeding
Not being able to answer questionnaires (in Dutch)
Mentally incompetent (patients not able to make decisions that are in their best interests, this will be evaluated by their treating physician (e.g. patients with an intellectual disability or mental retardation))
Alcohol or drug abuse
Patient with a known (es)ketamine allergy
Abnormal liver enzyme levels at baseline (ASAT, ALAT, GGT, AF, Bilirubin total)
Patients are allowed to continue the following pain medications: paracetamol, non-steroidal anti-inflammatory drugs as described previously by Sigtermans et al. (Trial NL466 (NTR507))\* according to their stable use in dose and frequency.
\*in case of tramadol, amitriptylin, selective serotonin reuptake-inhibitors, gabapentin and pregabalin, the usage may also be continued during this study.

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Interventions

DRUGEsketamine hydrochloride

Esketamine dosing regimen is set at 0.1 mg/kg/h as starting dosage. Dosage will be gradually increased based on heart rate, oxygen saturation, blood pressure and side effects (e.g. nausea and dissociative effects) during a period of 8 hours to a maximum of 0.5 mg/kg/h (in steps of 0.1-0.3-0.5 mg/kg/hour). This dosage regimen is similar to that used earlier by Sigtermans et al. \[1\].

DRUGPlacebo

8 hour infusion with saline (NaCl 0.9%)