Comparing opioid-free and opioid-based anesthesia for breast reconstruction surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the consumption of morphine in patients undergoing free flap reconstruction surgery of the breast, using either opioid-free anesthesia or conventional opioid-based anesthesia. It is a Phase III multicentric randomized controlled trial that will assess postoperative pain management and recovery outcomes. The primary focus is on the first 48 hours after surgery, evaluating the effectiveness of dexmedetomidine as an alternative to opioids. The study will involve women aged 18 and older who meet specific eligibility criteria.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Anne-Claire COYNE, PhD
• Email: anne-claire.coyne@curie.fr
• Phone: 0033156245765

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.