Opioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.
Recruiting
Phase 3
Interventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 158 (estimated)
- Sponsor
- Institut Curie · Other
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About This Trial
This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CA control group.
Trial Locations
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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 ac…
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