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

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorInstitut Curie

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Dexmedetomidine

Treatment groups

158 Participants
are divided into 2 treatment groups

Sponsors and collaborators