New monitoring method may ease pain after ovarian cancer surgery
NCT ID NCT04906187
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether using a special monitor (ANI) during ovarian cancer surgery to guide pain medicine can lower the chance of chronic pain three months after the operation. About 126 women having open surgery for ovarian cancer will be randomly assigned to standard care or the ANI-guided approach. The goal is to see if reducing morphine during surgery leads to less pain later.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 126 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2021
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Institut Bergonié
Bordeaux, 33076, France
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Other studies related to the condition(s) this trial covers.
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