Clinical trial · Interventional
Opioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.
NCT05439005CI-TRIAL-00102060OFOBArecruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CA control group.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexmedetomidine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- OFA group
- description
- OFA (Opioid Free Anaesthesia) group:
- interventionNames
- Drug: Dexmedetomidine
- type
- NO_INTERVENTION
- label
- CA control group
- description
- CA (Conventional Anaesthesia) control group:
Primary outcomes (1)
- measure
- comparison of Morphine consumption in the two groups
- timeFrame
- during the first 48 hours postoperatively
Secondary outcomes (13)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women aged 18 or older. 2. Patients with a French health insurance coverage (having a French social security number). 3. Patient eligible for free flap reconstruction surgery of the breastunder general anaesthesia. 4. Patient who has given written consent to participate in accordance with the regulations. 5. Having a negative blood pregnancy test for patients of childbea ring age. Exclusion Criteria: 1. Allergy or intolerance to any of the drugs (dexmedetomidine, remifentanil, lidocaine, propofol, dexamethasone, kétamine, ketoprofen, nefopam, paracetamol, morphine, ropivacaine, droperidol, ondansetron). 2. Known history of heart failure, arrhythmias and/or ischemic heart disease and/or severe renal insufficiency. 3. Pulse below 50bpm during anaesthesia consultation and/or under beta blocker treatment. 4. Treatment with ACEI/ARB. 5. Severe asthma. 6. Symptomatic gastric or duodenal ulcer with or without treatment. 7. Baseline systolic blood pressure \< 100 mmHg. 8. Chronic preoperative pain and/or use of WHO ladder step 2 or 3 analgesics preoperatively. 9. Patient already included in another therapeutic trial evaluating an experimental molecule. 10. Persons deprived of liberty or under guardianship. 11. Patients with suspected difficulties in assessing pain on a scale. 12. Inability to undergo trial medical monitoring due to geographic, social or psychological reasons.
References
Publications (1)
- DERIVEDSaad-Boutry M, Carton M, Ezzili C, Savignoni A. Opioid-free versus opioid-based anaesthesia for free-flap reconstruction surgery of the breast: protocol for a phase III, multicentre, randomised controlled study. BMJ Open. 2025 Feb 17;15(2):e070021. doi: 10.1136/bmjopen-2022-070021. PMID 39961716