NCT04906187

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
May 2021Jun 2026

First Submitted

Initial submission to the registry

May 20, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

May 31, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

4.8 years

First QC Date

May 20, 2021

Last Update Submit

January 28, 2026

Conditions

Ovarian Neoplasm

Keywords

ovarian neoplasmanalgesia monitoringpain measurementAnalgesia Nociception Index

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

    within one hour of extubation

  • Arm B : Patients' pain score on the VAS immediately postoperatively

    within one hour of extubation

  • Arm A : proportion of patients with a DN4 questionnaire score> 4, three months after surgery

    3 months after surgery

  • +1 more secondary outcomes

Study Arms (2)

Arm A : Experimental group with intraoperative ANI monitoring of nociception

EXPERIMENTAL
Other: Arm A : intraoperative ANI monitoring of nociception

Arm B : Control group without ANI intraoperative monitoring of nociception

OTHER
Other: Arm B : no specific monitoring of nociception

Interventions

Arm B : no specific monitoring of nociceptionOTHER

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.

Arm B : Control group without ANI intraoperative monitoring of nociception
Arm A : intraoperative ANI monitoring of nociceptionOTHER

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.

Arm A : Experimental group with intraoperative ANI monitoring of nociception

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Woman aged 18 years and over.
  • Histologically proven or strongly suspected ovarian carcinoma.
  • Indication for laparotomy surgery with xyphopubic incision.
  • Acceptance of epidural anesthesia.
  • Pain score ≤ 3 (VAS or Numeric Verbal Scale).
  • Free and informed consent.
  • Patient affiliated with a French social security scheme in accordance with French law on research involving human participants.

You may not qualify if:

  • Heart rhythm disturbances.
  • History of Cerebral Vascular Accident (CVA).
  • History of epilepsy.
  • Wearing a pacemaker.
  • Receiving morphine treatment preoperatively.
  • Medical contraindication to an epidural.
  • Patient unable to follow and adhere to trial procedures for geographic, social or psychological reasons.
  • Patient placed under guardianship or curatorship.
  • Patient already included in the present study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Bergonié

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2021

First Posted

May 28, 2021

Study Start

May 31, 2021

Primary Completion

April 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)