Opioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.
Recruiting now · Phase 3
Conditions studied: Breast Cancer
In brief
This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CA control group.
Key facts
- Study ID
- NCT05439005
- Run by
- Institut Curie
- People needed
- 158
- Starts
- 2022-12-07
- Expected to finish
- 2027-06-06
- Last updated by the study team
- 2026-01-30
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Institut Curie Paris — Paris, France (enrolling)
- Institut Curie Saint-Cloud — Saint-Cloud, France (enrolling)
- Gustave Roussy, Cancer Campus, Grand Paris — Villejuif, France (enrolling)
Full record on ClinicalTrials.gov
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