Monitoring pain management during ovarian cancer surgery to reduce chronic pain
Impact of Specific Monitoring of Intraoperative Analgesia Under General Anesthesia on Chronic Pain After Ovarian Cancer Surgery. The MONIALC Study.
This study is testing if using a special pain monitoring system during ovarian cancer surgery can help reduce chronic pain after the operation compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Institut Bergonié Academic / other |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT04906187 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of specific monitoring of intraoperative analgesia using the Analgesia Nociception Index (ANI) on chronic pain outcomes following laparotomy for ovarian cancer. Participants will be randomly assigned to either receive ANI monitoring or standard care without specific monitoring during surgery. The study aims to assess whether reduced morphine use, guided by real-time pain monitoring, can lead to lower chronic pain levels three months post-surgery. Pain and anxiety levels will be measured using Visual Analog Scale (VAS) scores and a neuropathic pain questionnaire at follow-up.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and over with histologically confirmed or suspected ovarian carcinoma who are scheduled for laparotomy surgery.
Not a fit: Patients with heart rhythm disturbances, a history of stroke, or those unable to adhere to trial procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce chronic post-surgical pain in women undergoing ovarian cancer surgery.
How similar studies have performed: Previous studies have shown promising results with similar monitoring techniques in pain management, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Woman aged 18 years and over. 2. Histologically proven or strongly suspected ovarian carcinoma. 3. Indication for laparotomy surgery with xyphopubic incision. 4. Acceptance of epidural anesthesia. 5. Pain score ≤ 3 (VAS or Numeric Verbal Scale). 6. Free and informed consent. 7. Patient affiliated with a French social security scheme in accordance with French law on research involving human participants. Exclusion Criteria: 1. Heart rhythm disturbances. 2. History of Cerebral Vascular Accident (CVA). 3. History of epilepsy. 4. Wearing a pacemaker. 5. Receiving morphine treatment preoperatively. 6. Medical contraindication to an epidural. 7. Patient unable to follow and adhere to trial procedures for geographic, social or psychological reasons. 8. Patient placed under guardianship or curatorship. 9. Patient already included in the present study.
Where this trial is running
Bordeaux
- Institut Bergonié — Bordeaux, France (Recruiting)
Study contacts
- Study coordinator: Arnaud DUBUISSON, Nurse
- Email: a.dubuisson@bordeaux.unicancer.fr
- Phone: (0)5.56.33.37.30
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.