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NCT Number: NCT04906187

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Ovarian Neoplasm Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut Bergonié

Bordeaux, 33076, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Arm A : intraoperative ANI monitoring of nociception

Other

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 B : no specific monitoring of nociception

Other

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.

Primary outcomes

  1. Proportion of patients with a pain score on the self-assessment VAS > 4, three months after the surgery.

    Time frame: 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 outcomes

  1. Arm A : total dose of opioids received intraoperatively

    Time frame: Surgery

  2. Arm B : total dose of opioids received intraoperatively

    Time frame: Surgery

  3. Arm A : Patients' pain score on the VAS immediately postoperatively

    Time frame: 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

    Time frame: 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

    Time frame: 3 months after surgery

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

    Time frame: 3 months after surgery

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Registry information

Official study title

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

Acronym: MONIALC

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
May 28, 2021
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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