EASYlight study

Phase 1

Recruiting

Conditions: Endometriosis
Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: CTIS2023-508417-16-00

Lead Sponsor: Reinier de Graaf Groep

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 56

Inclusion Criteria

All pre-menopausal women aged above 18 years, Women (endometriosis is a condition exclusive to females), - Diagnosed with endometriosis (ultrasound, MRI or previous laparoscopic and/or diagnostic surgery) according to the #Enzian classification. 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) 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 Criteria

- Pain score <6 out of 10 (NRS) for chronic pelvic pain, - 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, - Endometriosis affecting the bladder and ureter, -Patient with a known (es)ketamine allergy, -Abnormal liver enzyme levels at baseline (ASAT, ALAT, GGT, AF, Bilirubin total), defined in protocol V4, - 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary aim of the EASYlight study is to assess the effect of 8 hour esketamine infusion versus placebo (saline) on the numeric rating scale score (NRS score) for chronic pelvic pain in patients with chronic pain associated with endometriosis.;Secondary Objective: Treatment experience, NRS scores for dysmenorrhea, dysuria, dyschezia, dyspareunia and chronic pelvic pain, Depressive symptoms, Quality of life, Pain coping and cognition, Work productivity, Health care utilization;Primary end point(s): NRS score for chronic pelvic pain 4 weeks after the 8 hour infusion treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Pain scores (NRS scores for dysmenorrhea, dyschezia, dysuria, dyspareunia and chronic pelvic pain);Secondary end point(s):Treatment experience (including side-effects) (Bond&Ladder questionnaire, Bowdle questionnaire, treatment experience rating (on a scale of 0-10);Secondary end point(s):Depressive symptoms (HADS);Secondary end point(s):Quality of life (EHP-30, EQ-5D-5L);Secondary end point(s):Cost-effectiveness (adjusted iPCQ, adjusted iMCQ);Secondary end point(s):Pain coping and cognition (PCCL)