Clinical trial · Interventional
Impact of Specific Monitoring of Intraoperative Analgesia Under General Anesthesia on Chronic Pain After Ovarian Cancer Surgery
Impact of Specific Monitoring of Intraoperative Analgesia Under General Anesthesia on Chronic Pain After Ovarian Cancer Surgery. The MONIALC Study.
NCT04906187CI-TRIAL-00102077MONIALCcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Neoplasm | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arm A : intraoperative ANI monitoring of nociception | Other | — | UNRESOLVED |
| Arm B : no specific monitoring of nociception | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A : Experimental group with intraoperative ANI monitoring of nociception
- interventionNames
- Other: Arm A : intraoperative ANI monitoring of nociception
- type
- OTHER
- label
- Arm B : Control group without ANI intraoperative monitoring of nociception
- interventionNames
- Other: Arm B : no specific monitoring of nociception
Primary outcomes (1)
- measure
- Proportion of patients with a pain score on the self-assessment VAS > 4, three months after the surgery.
- timeFrame
- 3 months after surgery
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.