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

Not Applicable

Recruiting

• Conditions: Ovarian Neoplasm

• Registration Number: NCT04906187
• Lead Sponsor: Institut Bergonié

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.

Study Timeline

• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2021-05-27
• Study First Posted: 2021-05-28
• Study Start: 2021-05-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-18
• Primary Completion: 2025-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 126

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of patients with a pain score on the self-assessment VAS > 4, three months after the surgery.	3 months after surgery	The Visual Analog Scale (VAS) is a validated, reliable and reproducible tool. The VAS will be used to measure pain. This self-assessment scale allows the patient to evaluate his or her pain from 0 to 10 "0=No pain" to "10=Maximum imaginable pain ". A pain VAS score of 4 and above is considered clinically significant.

Secondary Outcome Measures

Name	Time	Method
Arm B : total dose of opioids received intraoperatively	Surgery
Arm A : Patients' pain score on the VAS immediately postoperatively	within one hour of extubation	The Visual Analog Scale (VAS) is a validated, reliable and reproducible tool. The VAS will be used to measure pain. This self-assessment scale allows the patient to evaluate his or her pain from 0 to 10 "0=No pain" to "10=Maximum imaginable pain ". A pain VAS score of 4 and above is considered clinically significant.
Arm B : Patients' pain score on the VAS immediately postoperatively	within one hour of extubation	The Visual Analog Scale (VAS) is a validated, reliable and reproducible tool. The VAS will be used to measure pain. This self-assessment scale allows the patient to evaluate his or her pain from 0 to 10 "0=No pain" to "10=Maximum imaginable pain ". A pain VAS score of 4 and above is considered clinically significant.
Arm A : proportion of patients with a DN4 questionnaire score> 4, three months after surgery	3 months after surgery
Arm B : Arm A : proportion of patients with a DN4 questionnaire score> 4, three months after surgery	3 months after surgery
Arm A : total dose of opioids received intraoperatively	Surgery

Trial Locations

Locations (1)

Institut Bergonié; 🇫🇷 Bordeaux, France