Status:
RECRUITING
Impact of Specific Monitoring of Intraoperative Analgesia Under General Anesthesia on Chronic Pain After Ovarian Cancer Surgery
Lead Sponsor:
Institut Bergonié
Conditions:
Ovarian Neoplasm
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 Nocicepti...
Detailed Description
Prior to carrying out the research, the informed consent of the person must be obtained after being informed of the purpose of the research, its conduct and duration, benefits, potential risks and con...
Eligibility Criteria
Inclusion
- Woman aged 18 years and over.
- Histologically proven or strongly suspected ovarian carcinoma.
- Indication for laparotomy surgery with xyphopubic incision.
- Acceptance of epidural anesthesia.
- Pain score ≤ 3 (VAS or Numeric Verbal Scale).
- Free and informed consent.
- Patient affiliated with a French social security scheme in accordance with French law on research involving human participants.
Exclusion
- Heart rhythm disturbances.
- History of Cerebral Vascular Accident (CVA).
- History of epilepsy.
- Wearing a pacemaker.
- Receiving morphine treatment preoperatively.
- Medical contraindication to an epidural.
- Patient unable to follow and adhere to trial procedures for geographic, social or psychological reasons.
- Patient placed under guardianship or curatorship.
- Patient already included in the present study.
Key Trial Info
Start Date :
May 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT04906187
Start Date
May 31 2021
End Date
December 1 2025
Last Update
November 18 2024
Active Locations (1)
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1
Institut Bergonié
Bordeaux, France, 33076