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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ovarian Neoplasm
• Intervention / Treatment: Other: Arm A : intraoperative ANI monitoring of nociception; Other: Arm B : no specific monitoring of nociception

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 Type: Interventional
• Enrollment (Anticipated): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Recruiting
    • Institut Bergonié

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with a pain score on the self-assessment VAS > 4, three months after the 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.	3 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arm A : total dose of opioids received intraoperatively		Surgery
Arm B : total dose of opioids received intraoperatively		Surgery
Arm A : Patients' pain score on the VAS immediately postoperatively	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.	within one hour of extubation
Arm B : Patients' pain score on the VAS immediately postoperatively	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.	within one hour of extubation
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

Collaborators and Investigators

• Sponsor: Institut Bergonié

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2021
• Primary Completion (Anticipated): February 25, 2024
• Study Completion (Anticipated): August 25, 2024

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: pain measurement; Analgesia Nociception Index; ovarian neoplasm; analgesia monitoring
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Chronic Pain; Ovarian Neoplasms
• Other Study ID Numbers: IB 2020-04; 2020-A02767-32 (Other Identifier: ANSM IDRCB number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No