RecruitingPhase 3

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

France158 participantsStarted 2022-12-07

Plain-language summary

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

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

comparison of Morphine consumption in the two groups

Timeframe: during the first 48 hours postoperatively

NCT IDNCT05439005

SponsorInstitut Curie

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-06

Anne-Claire COYNE, PhD

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.