Opioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.
NCT ID: NCT05439005
Last Updated: 2026-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
158 participants
INTERVENTIONAL
2022-12-07
2027-06-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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OFA group
OFA (Opioid Free Anaesthesia) group:
Dexmedetomidine
Dexmedetomidine+Lidocaine
CA control group
CA (Conventional Anaesthesia) control group:
No interventions assigned to this group
Interventions
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Dexmedetomidine
Dexmedetomidine+Lidocaine
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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Institut Curie
OTHER
Responsible Party
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Principal Investigators
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Mary SAAD, MD
Role: STUDY_DIRECTOR
Institut Curie Saint-Cloud
Locations
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Institut Curie Paris
Paris, , France
Institut Curie Saint-Cloud
Saint-Cloud, , France
Gustave Roussy, Cancer Campus, Grand Paris
Villejuif, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Saad-Boutry M, Carton M, Ezzili C, Savignoni A. Opioid-free versus opioid-based anaesthesia for free-flap reconstruction surgery of the breast: protocol for a phase III, multicentre, randomised controlled study. BMJ Open. 2025 Feb 17;15(2):e070021. doi: 10.1136/bmjopen-2022-070021.
Other Identifiers
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IC 2021-07
Identifier Type: -
Identifier Source: org_study_id
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