EASYlight study
Key facts
- Where
- Delft, HollandiaSee the site
- Phase
- 4. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Hollandia
- Reinier de Graaf GroepDelft, HollandiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Reinier de Graaf Groep
- Trial code
- EU 2023-508417-16-00
- Record updated
- 2024. július 5.
- Original description
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.Read full original descriptionShow less
Esketamine As treatment for chronic pain due to endometrioSis: a RCT studY
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.
Inclusion: 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: Usage of strong opioid medication; 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; Unstable angina, heart failure, history of cerebral vascular accident (CVA); Patients suffering from an active infection; Patients with epilepsy; 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; 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; Pain score <6 out of 10 (NRS) for chronic pelvic pain; Patients with glaucoma; Usage of xanthine derivatives or ergometrine; Patients trying to achieve pregnancy and or patients who are breastfeeding; Not being able to answer questionnaires (in Dutch); Increased intracranial pressure.