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

RECRUITINGPHASE3

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

NCT05439005•Institut Curie

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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.
+2 more criteria

Locations (3)

Institut Curie Paris

Paris, France

Institut Curie Saint-Cloud

Saint-Cloud, France

Gustave Roussy, Cancer Campus, Grand Paris

Villejuif, France

Key Dates

Start Date

December 7, 2022

Primary Completion Date

June 6, 2027

Completion Date

June 6, 2027

Last Updated

January 30, 2026

Enrollment

158

ESTIMATED participants

Conditions

Breast Cancer

Interventions

Dexmedetomidine

DRUG

Contacts

Anne-Claire COYNE, PhD

CONTACT

0033156245765 anne-claire.coyne@curie.fr

Mary SAAD, MD

CONTACT

0033147112371 mary.saad@curie.fr

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

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Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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