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Search / Trial NCT04906187

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

Launched by INSTITUT BERGONIÉ · May 27, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Ovarian Neoplasm Analgesia Monitoring Pain Measurement Analgesia Nociception Index

ClinConnect Summary

This clinical trial is looking at how monitoring pain relief during surgery can affect long-term pain after surgery for ovarian cancer. Specifically, it aims to see if using a special tool called the Analgesia Nociception Index (ANI) to reduce the amount of morphine given during surgery can help patients have less chronic pain three months after their operation. The study is currently recruiting women aged 18 and older who have been diagnosed with ovarian cancer and are scheduled for a specific type of surgery.

To participate, women must be able to accept epidural anesthesia (a type of pain relief used during surgery) and have a low level of pain before the operation. Certain health conditions, like heart problems or a history of stroke, may prevent someone from joining the study. Participants can expect to be monitored closely during their surgery and will receive care according to the study's plan. This research could help improve pain management for future patients undergoing similar surgeries.

Gender

FEMALE

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.

About Institut Bergonié

Institut Bergonié is a leading cancer research and treatment center based in Bordeaux, France, renowned for its commitment to advancing oncology through innovative clinical trials and cutting-edge therapies. As a prominent sponsor of clinical research, the institute focuses on improving patient outcomes and quality of life by integrating multidisciplinary approaches in cancer care. With a strong emphasis on collaboration and translational research, Institut Bergonié actively engages in partnerships with academic institutions, industry leaders, and healthcare organizations to foster advancements in cancer treatment and enhance the understanding of malignancies. Its dedication to excellence in patient care and research positions Institut Bergonié at the forefront of the fight against cancer.

Locations

Bordeaux, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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