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Clinical Trials in France / NCT05439005
Recruiting Phase 3

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

NCT05439005 · tracked via the Priya Life Science France tracker
Sponsor
Institut Curie
Phase
Phase 3
Started
2022-12-07
Last updated
2026-01-30

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Dexmedetomidine →

Dexmedetomidine: Dexmedetomidine+Lidocaine

Study summary

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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • comparison of Morphine consumption in the two groups — during the first 48 hours postoperatively

Trial sites (3)

FacilityCityRegionStatus
Institut Curie Paris Paris France Recruiting
Institut Curie Saint-Cloud Saint-Cloud France Recruiting
Gustave Roussy, Cancer Campus, Grand Paris Villejuif France Recruiting

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Other trials for the same condition

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Persistent Organic Pollutants and Breast Cancers (POPCASE) Active, not recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05439005 on ClinicalTrials.gov ↗ ← All trials in France