Status:
RECRUITING
Opioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.
Lead Sponsor:
Institut Curie
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CA control group.
Eligibility Criteria
Inclusion
- Women aged 18 or older.
- Patients with a French health insurance coverage (having a French social security number).
- Patient eligible for free flap reconstruction surgery of the breastunder general anaesthesia.
- Patient who has given written consent to participate in accordance with the regulations.
- Having a negative blood pregnancy test for patients of childbea ring age.
Exclusion
- Allergy or intolerance to any of the drugs (dexmedetomidine, remifentanil, lidocaine, propofol, dexamethasone, kétamine, ketoprofen, nefopam, paracetamol, morphine, ropivacaine, droperidol, ondansetron).
- Known history of heart failure, arrhythmias and/or ischemic heart disease and/or severe renal insufficiency.
- Pulse below 50bpm during anaesthesia consultation and/or under beta blocker treatment.
- Treatment with ACEI/ARB.
- Severe asthma.
- Symptomatic gastric or duodenal ulcer with or without treatment.
- Baseline systolic blood pressure \< 100 mmHg.
- Chronic preoperative pain and/or use of WHO ladder step 2 or 3 analgesics preoperatively.
- Patient already included in another therapeutic trial evaluating an experimental molecule.
- Persons deprived of liberty or under guardianship.
- Patients with suspected difficulties in assessing pain on a scale.
- Inability to undergo trial medical monitoring due to geographic, social or psychological reasons.
Key Trial Info
Start Date :
December 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2026
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT05439005
Start Date
December 7 2022
End Date
March 15 2026
Last Update
September 19 2025
Active Locations (3)
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1
Institut Curie Paris
Paris, France, 75005
2
Institut Curie Saint-Cloud
Saint-Cloud, France, 92210
3
Gustave Roussy, Cancer Campus, Grand Paris
Villejuif, France