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

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

This study is testing whether using an opioid-free anesthesia during breast reconstruction surgery can help women manage pain and recover better compared to traditional opioid-based anesthesia.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 158 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Institut Curie (other)
• Locations: 3 sites (Paris and 2 other locations)
• Trial ID: NCT05439005 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18 or older who are eligible for free flap reconstruction surgery and have French health insurance.

Not a fit: Patients with allergies to the study medications or those with significant cardiovascular or respiratory conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management and reduced opioid use in breast reconstruction surgery patients.

How similar studies have performed: Other studies have shown promising results with opioid-sparing techniques in surgical settings, suggesting potential success for this approach.

Eligibility criteria

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 this trial is running

Paris and 2 other locations

• 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

Conditions: Breast Cancer, free flap reconstruction surgery, anaesthesia