EASYlight study

INTERVENTION: Product Name: Ketanest® S 5 mg/ml ‐ Ampullen,Product Code: PRD392897,Pharmaceutical Form: SOLUTION FOR INJECTION,Other descriptive name: ,Strength: Esketamine Hydrochloride 5.77mg,Product Name: Ondansetron 2 mg/ml Solution for Injection,Product Code: PRD10011746,Pharmaceutical Form: SOLUTION FOR INJECTION,Other descriptive name: ,Strength: Ondansetron 2mg,Product Name: SODIUM CHLORIDE,Product Code: SUB12581MIG,Pharmaceutical Form: SOLUTION FOR INJECTION,Other descriptive name: ,Strength: 0.9%,Pharmaceutical form of the placebo: SOLUTION FOR INJECTION,Route of administration of the placebo: INTRAVENOUS,Product Name: Ondansetron Morningside 4 mg orodispergeerbare tabletten,Product Code: PRD10416608,Pharmaceutical Form: ORODISPERSIBLE TABLET,Other descriptive name: ,Strength: Ondansetron 4mg CONDITION: Endometriosis Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03]‐Diseases [C] ‐ Female Urogenital Diseases and Pregnancy Complications [C13] PRIMARY OUTCOME: 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. Primary end point(s):NRS score for chronic pelvic pain 4 weeks after the 8 hour infusion treatment 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 SECONDARY OUTCOME: Secondary end point(s):Cost‐effectiveness (adjusted iPCQ, adjusted iMCQ) Secondary end point(s):Depressive symptoms (HADS) Secondary end point(s):Pain coping and cognition (PCCL) Secondary end point(s):Pain scores (NRS scores for dysmenorrhea, dyschezia, dysuria, dyspareunia and chronic pelvic pain) Secondary end point(s):Quality of life (EHP‐30, EQ‐5D‐5L) Secondary end point(s):Treatment experience (including side‐effects) (Bond&Ladder questionnaire, Bowdle questionnaire, treatment experience rating (on a scale of 0‐10) 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