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

Institut Curie

Status and phase

Enrolling

Phase 3

Conditions

Breast Cancer

Treatments

Drug: Dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

IC 2021-07

Details and patient eligibility

About

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

Enrollment

158 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.