New anesthesia method could cut opioid use after breast reconstruction

NCT ID NCT05439005

Symptom relief Sponsor: Institut Curie Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares opioid-free anesthesia using dexmedetomidine and lidocaine to standard opioid-based anesthesia in 158 women undergoing breast reconstruction after cancer. The goal is to see if the opioid-free approach reduces morphine use and side effects in the first 48 hours after surgery. Researchers will also monitor pain, nausea, and recovery quality.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Dexmedetomidine and Lidocaine
What this could lead to: If successful, this could offer a safer anesthesia option for breast reconstruction, reducing opioid use and related side effects like nausea and drowsiness.
What could go wrong: This is a moderate-sized phase 3 trial, but results may not apply to all patients or surgeries. The opioid-free approach might not control pain as effectively for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 158 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

3 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

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New anesthesia method could cut opioid use after breast reconstruction

What the study statuses mean