Impact of Specific Monitoring of Intraoperative Analgesia Under General Anesthesia on Chronic Pain After Ovarian Cancer Surgery
CompletedNot applicableNCT04906187
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This is a single-center, randomized, phase II, non-comparative, single-blind clinical study that will determine whether morphine reduction through intraoperative monitoring by ANI (Analgesia Nociception Index) significantly reduces chronic post-surgical pain at three months after laparotomy for ovarian carcinoma with regard to standard care.
Study details
- Official title
- Impact of Specific Monitoring of Intraoperative Analgesia Under General Anesthesia on Chronic Pain After Ovarian Cancer Surgery. The MONIALC Study.
- Conditions
- Ovarian Neoplasm
- Interventions
- Other: Arm A : intraoperative ANI monitoring of nociception
- Other: Arm B : no specific monitoring of nociception
- Sponsor
- Institut Bergonié
- Start date
- 2021-05-31
- Primary completion
- 2026-04-16
- Sex
- Female
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- France
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04906187