Using low-dose ketamine during surgery to treat endometriosis pain
Endometriosis and Pain Treatment by Intraoperative Administration of Low-dose Ketamine A Single-Centre, Prospective, Randomized, Controlled Trial
This study is testing if giving low-dose ketamine during surgery can help reduce pain and improve recovery for people with endometriosis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT06951802 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of intraoperative administration of low-dose ketamine during laparoscopic surgery for endometriosis on postoperative pain outcomes. It aims to compare pain levels experienced by patients who receive ketamine versus those who do not, focusing on the management of chronic pelvic pain associated with endometriosis. The study includes patients aged 18 and older who are undergoing surgery for endometriosis at the Inselspital, Bern University Hospital. The trial will assess the effectiveness of ketamine in reducing the need for opioids and improving recovery after surgery.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with known or suspected endometriosis who are scheduled for laparoscopic surgery requiring general anesthesia.
Not a fit: Patients with severe comorbidities, such as cardiovascular instability or those who are pregnant, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative pain and opioid use in women undergoing surgery for endometriosis.
How similar studies have performed: Previous studies have shown that ketamine can be effective in managing postoperative pain, suggesting potential success for this approach in treating endometriosis-related pain.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing surgery for endometriosis operation requiring general anaesthesia at the Inselspital, Bern University Hospital, University of Bern, Department of gynaecology and obstetrics. * Age ≥ 18 years * American Society of Anesthesiologist (ASA) physical status 1-3 * Patients with known or suspected endometriosis * Written informed consent. Exclusion Criteria: * Age \< 18 years * ASA physical status ≥4 * Higher-grade atrioventricular block without pacemaker * Severe hypovolemia or bradycardia * Uncontrolled hyper- or hypotension * Liver disease * Known malignant hyperthermia * Cardiovascular instability or severe heart failure (New York Heart Association classification (NYHA) \> III) * Myocardial infarction during the last 30 days prior to surgery * Increased intracranial or increased intraocular pressure * Limited peripheral autonomic activity, hypersensitivity to ketamine or propofol or its components * Pregnancy * Rejection or lack of consent of the patient or relatives
Where this trial is running
Bern
- Inselspital Bern — Bern, Switzerland (Recruiting)
Study contacts
- Study coordinator: Christian Vetter, MD
- Email: christian.vetter@insel.ch
- Phone: +416343776
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.