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

Sponsor
Institut Bergonié (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04906187
Collaborator
(none)
126
1
2
27
4.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Arm A : intraoperative ANI monitoring of nociception
  • Other: Arm B : no specific monitoring of nociception
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
126 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Impact of Specific Monitoring of Intraoperative Analgesia Under General Anesthesia on Chronic Pain After Ovarian Cancer Surgery. The MONIALC Study.
Anticipated Study Start Date :
May 25, 2021
Anticipated Primary Completion Date :
Feb 25, 2023
Anticipated Study Completion Date :
Aug 25, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A : Experimental group with intraoperative ANI monitoring of nociception

Other: 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.

Other: Arm B : Control group without ANI intraoperative monitoring of nociception

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Arm A : total dose of opioids received intraoperatively [Surgery]

  2. Arm B : total dose of opioids received intraoperatively [Surgery]

  3. 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.

  4. 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.

  5. Arm A : proportion of patients with a DN4 questionnaire score> 4, three months after surgery [3 months after surgery]

  6. Arm B : Arm A : proportion of patients with a DN4 questionnaire score> 4, three months after surgery [3 months after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Woman aged 18 years and over.

  2. Histologically proven 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut Bergonié Bordeaux France 33076

Sponsors and Collaborators

  • Institut Bergonié

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT04906187
Other Study ID Numbers:
  • IB 2020-04
  • 2020-A02767-32
First Posted:
May 28, 2021
Last Update Posted:
May 28, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Institut Bergonié
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 28, 2021