Clinical trial NCT04906187: Impact of Specific Monitoring of Intraoperative Analgesia Under General Anesthesia on Chronic Pain After Ovarian Cancer Surgery
Official title: Impact of Specific Monitoring of Intraoperative Analgesia Under General Anesthesia on Chronic Pain After Ovarian Cancer Surgery. The MONIALC Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Neoplasm
Keywords: ovarian neoplasm
analgesia monitoring
pain measurement
Analgesia Nociception Index
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Proportion of patients with a pain score on the self-assessment VAS > 4, three months after the surgery.
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Arm A : total dose of opioids received intraoperatively
timeFrame: Surgery
measure: Arm B : total dose of opioids received intraoperatively
timeFrame: Surgery
measure: Arm A : Patients' pain score on the VAS immediately postoperatively
timeFrame: within one hour of extubation
measure: Arm B : Patients' pain score on the VAS immediately postoperatively
timeFrame: within one hour of extubation
measure: Arm A : proportion of patients with a DN4 questionnaire score> 4, three months after surgery
timeFrame: 3 months after surgery
measure: Arm B : Arm A : proportion of patients with a DN4 questionnaire score> 4, three months after surgery
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
Study officials:
References: