Opioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.

Recruiting · NCT05439005 · Interventional (participants receive a specific treatment) · Lead sponsor: Institut Curie

Interventions studied

This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CA control group.

Age range

18 Years and older

Sex

Female

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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.

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.

3 locations listed.