Impact of Specific Monitoring of Intraoperative Analgesia Under General Anesthesia on Chronic Pain After Ovarian Cancer Surgery

NCT ID: NCT04906187

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-31
• Study Completion Date: 2026-06-30

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 Nociception Index) significantly reduces chronic post-surgical pain at three months after laparotomy for ovarian carcinoma with regard to standard care.

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 constraints of the study.

Before inclusion,all eligibility criteria will be verified, VAS pain score and VAS anxiety will be performed.

The surgical procedure for ovarian carcinoma will be performed by laparotomy and the intraoperative monitoring of nociception wil depend of the randomization arm : Intraoperative ANI monitoring of nociception (experimental arm) versus no specific monitoring of nociception (control arm). The total dose of opioids (in micrograms) received by the patients will be recorded at the end of the surgery.

VAS pain score will be performed immediately postoperatively and at three months after the intervention. A DN4 questionnaire (neuropathic pain) will be evaluated at three months after the intervention.

Conditions

Ovarian Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Arm A : Experimental group with intraoperative ANI monitoring of nociception

Group Type: EXPERIMENTAL

Arm A : intraoperative ANI monitoring of nociception

Intervention Type: OTHER

For the experimental group (arm A), the sufentanil doses are adjusted to maintain an ANI between 50 and 70. Morphine doses are adjusted from 0.05 to 0.05 µg / ml. Intraoperative data will be collected for ANI, TIVA and hemodynamics.

Arm B : Control group without ANI intraoperative monitoring of nociception

Group Type: OTHER

Arm B : no specific monitoring of nociception

Intervention Type: OTHER

For the control group (arm B), adjustments to the opioid doses are made in relation to the hemodynamic reactions of the patient and the operating times. Intraoperative data will be collected for TIVA and hemodynamics.

Interventions

Arm A : intraoperative ANI monitoring of nociception

For the experimental group (arm A), the sufentanil doses are adjusted to maintain an ANI between 50 and 70. Morphine doses are adjusted from 0.05 to 0.05 µg / ml. Intraoperative data will be collected for ANI, TIVA and hemodynamics.

Intervention Type: OTHER

Arm B : no specific monitoring of nociception

For the control group (arm B), adjustments to the opioid doses are made in relation to the hemodynamic reactions of the patient and the operating times. Intraoperative data will be collected for TIVA and hemodynamics.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Bergonié

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut Bergonié

Bordeaux, , France

Countries

France

Other Identifiers

2020-A02767-32

Identifier Type: OTHER

Identifier Source: secondary_id

IB 2020-04

Identifier Type: -

Identifier Source: org_study_id