Recruiting
Opioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.
This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CA control group.
ClinicalTrials.gov IDNCT05439005
PhasePHASE3
Enrollment158
SponsorInstitut Curie
Age18 Years
SexFEMALE
Conditions studied
Breast Cancer
About this study
This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CA control group.
Interventions
- Drug: Dexmedetomidine — Dexmedetomidine+Lidocaine
Primary outcomes
- comparison of Morphine consumption in the two groups (during the first 48 hours postoperatively)
Eligibility information
Inclusion Criteria:
1. Women aged 18 or older.
2. Patients with a French health insurance coverage (having a French social security number).
3. Patient eligible for free flap reconstruction surgery of the breastunder general anaesthesia.
4. Patient who has given written consent to participate in accordance with the regulations.
5. Having a negative blood pregnancy test for patients of childbea ring age.
Exclusion Criteria:
1. Allergy or intolerance to any of the drugs (dexmedetomidine, remifentanil, lidocaine, propofol, dexamethasone, kétamine, ketoprofen, nefopam, paracetamol, morphine, ropivacaine, droperidol, ondansetron).
2. Known history of heart failure, arrhythmias and/or ischemic heart disease and/or severe renal insufficiency.
3. Pulse below 50bpm during anaesthesia consultation and/or under beta blocker treatment.
4. Treatment with ACEI/ARB.
5. Severe asthma.
6. Symptomatic gastric or duodenal ulcer with or without treatment.
7. Baseline systolic blood pressure \< 100 mmHg.
8. Chronic preoperative pain and/or use of WHO ladder step 2 or 3 analgesics preoperatively.
9. Patient already included in another therapeutic trial evaluating an experimental molecule.
10. Persons deprived of liberty or under guardianship.
11. Patients with suspected difficulties in assessing pain on a scale.
12. Inability to undergo trial medical monitoring due to geographic, social or psychological reasons.
Study locations
- Institut Curie Paris, Paris, 75005 France
- Institut Curie Saint-Cloud, Saint-Cloud, 92210 France
- Gustave Roussy, Cancer Campus, Grand Paris, Villejuif, France
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.