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

Institut Bergonié

Status: Enrolling

Conditions: Ovarian Neoplasm

Treatments: Other: Arm B : no specific monitoring of nociception; Other: Arm A : intraoperative ANI monitoring of nociception

Study type: Interventional

Funder types: Other

Identifiers

NCT04906187

IB 2020-04

2020-A02767-32 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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126 participants in 2 patient groups

Arm A : Experimental group with intraoperative ANI monitoring of nociception

Experimental group

Treatment:

Other: Arm A : intraoperative ANI monitoring of nociception

Arm B : Control group without ANI intraoperative monitoring of nociception

Other group

Treatment:

Other: Arm B : no specific monitoring of nociception