Actively Recruiting
Opioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.
Led by Institut Curie · Updated on 2026-01-30
158
Participants Needed
3
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CA control group.
CONDITIONS
Official Title
Opioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 or older
- Patients with French health insurance coverage (French social security number)
- Eligible for free flap reconstruction surgery of the breast under general anesthesia
- Provided written consent to participate
- Negative blood pregnancy test for patients of childbearing age
You will not qualify if you...
- Allergy or intolerance to drugs such as dexmedetomidine, remifentanil, lidocaine, propofol, dexamethasone, ketamine, ketoprofen, nefopam, paracetamol, morphine, ropivacaine, droperidol, ondansetron
- History of heart failure, arrhythmias, ischemic heart disease, or severe renal insufficiency
- Pulse below 50 bpm during anesthesia consultation or beta blocker treatment
- Treatment with ACE inhibitors or ARBs
- Severe asthma
- Symptomatic gastric or duodenal ulcer
- Baseline systolic blood pressure below 100 mmHg
- Chronic preoperative pain or use of WHO ladder step 2 or 3 analgesics preoperatively
- Already included in another therapeutic trial evaluating an experimental molecule
- Persons deprived of liberty or under guardianship
- Difficulties assessing pain on a scale
- Inability to undergo trial medical monitoring due to geographic, social, or psychological reasons
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Institut Curie Paris
Paris, France, 75005
Actively Recruiting
2
Institut Curie Saint-Cloud
Saint-Cloud, France, 92210
Actively Recruiting
3
Gustave Roussy, Cancer Campus, Grand Paris
Villejuif, France
Actively Recruiting
Research Team
A
Anne-Claire COYNE, PhD
CONTACT
M
Mary SAAD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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