Using pain monitoring to improve pain management during endometriosis surgery
Influence of Intraoperative Nociception Guided Analgesia on Perioperative Analgesia Consumption in Patients Undergoing Laparoscopic Resection of Endometriosis
This study is testing if a new way to monitor pain during endometriosis surgery can help reduce the amount of pain medication needed and improve recovery for women having the surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Spital Limmattal Schlieren Academic / other |
| Locations | 1 site (Schlieren, Zürich) |
| Trial ID | NCT06732050 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of intraoperative nociception guided analgesia on the total analgesic requirements for patients undergoing laparoscopic surgery for endometriosis or adenomyosis. By utilizing the Nociception Level (NOL®) index, which measures the body's sympathetic responses to pain, the study aims to provide a more objective assessment of pain during surgery. This approach seeks to minimize the risks associated with both under-treatment and over-treatment of pain, ultimately improving postoperative outcomes. The study will include premenopausal females aged 18 and older who are scheduled for relevant surgical procedures.
Who should consider this trial
Good fit: Ideal candidates are premenopausal females aged 18 and older undergoing laparoscopic surgery for suspected endometriosis or adenomyosis.
Not a fit: Patients under 18, those with contraindications to opioids or other standard medications, and individuals requiring intensive care postoperatively may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better pain management and reduced opioid use for patients undergoing surgery for endometriosis.
How similar studies have performed: While the use of nociception monitoring is a relatively novel approach, preliminary studies have shown promise in improving pain management outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Premenopausal females * Undergoes any type of laparoscopic surgery for suspected endometriosis or adenomyosis (diagnostic/therapeutic and/or hysterectomy) Exclusion Criteria: * Age \< 18 years * Patients with contraindications for opioids and/or ketamine/clonidine (standard medications) * Pregnant or breastfeeding women * Lack of ability to follow the study procedure, e.g. due to severe language barriers, mental disorders, dementia * Patients requiring preoperative or postoperative treatment in the intensive care unit * Patients with conditions precluding the use of the NOL® sensor, such as neuromuscular deficits affecting hand function * Regular consumption of opioids (Mankoski Score ≥6)
Where this trial is running
Schlieren, Zürich
- Spital Limmattal — Schlieren, Zürich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Isabel Marcolino, Dr. med. — Spital STS AG
- Study coordinator: Isabel Marcolino, Dr. med.
- Email: isabel.marcolino@spital-limmattal.ch
- Phone: 044 736 82 18
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.