Opioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.
OFOBA
1 other identifier
interventional
158
1 country
3
Brief Summary
This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CA control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 breast-cancer
Started Dec 2022
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2022
CompletedFirst Posted
Study publicly available on registry
June 30, 2022
CompletedStudy Start
First participant enrolled
December 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 6, 2027
January 30, 2026
January 1, 2026
4.5 years
June 27, 2022
January 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
comparison of Morphine consumption in the two groups
during the first 48 hours postoperatively
Secondary Outcomes (13)
Assessment of vasopressor requirement and total intraoperative filling volume
end of surgery
Assessment of the state of consciousness on arrival in the PACU
on arrival in the PACU
Assessment of the incidence of PONV in the PACU, at D0, D1 and D2
in the PACU, at D0, D1 and D2
Maximum VAS at rest and mobilization in the PACU, at D0, D1 and D2
in the PACU, at D0, D1 and D2
Dose of morphine given in titration in the PACU (mg)
in the PACU
- +8 more secondary outcomes
Study Arms (2)
OFA group
EXPERIMENTALOFA (Opioid Free Anaesthesia) group:
CA control group
NO INTERVENTIONCA (Conventional Anaesthesia) control group:
Interventions
Eligibility Criteria
You may qualify if:
- Women aged 18 or older.
- Patients with a French health insurance coverage (having a French social security number).
- Patient eligible for free flap reconstruction surgery of the breastunder general anaesthesia.
- Patient who has given written consent to participate in accordance with the regulations.
- Having a negative blood pregnancy test for patients of childbea ring age.
You may not qualify if:
- Allergy or intolerance to any of the drugs (dexmedetomidine, remifentanil, lidocaine, propofol, dexamethasone, kétamine, ketoprofen, nefopam, paracetamol, morphine, ropivacaine, droperidol, ondansetron).
- Known history of heart failure, arrhythmias and/or ischemic heart disease and/or severe renal insufficiency.
- Pulse below 50bpm during anaesthesia consultation and/or under beta blocker treatment.
- Treatment with ACEI/ARB.
- Severe asthma.
- Symptomatic gastric or duodenal ulcer with or without treatment.
- Baseline systolic blood pressure \< 100 mmHg.
- Chronic preoperative pain and/or use of WHO ladder step 2 or 3 analgesics preoperatively.
- Patient already included in another therapeutic trial evaluating an experimental molecule.
- Persons deprived of liberty or under guardianship.
- Patients with suspected difficulties in assessing pain on a scale.
- Inability to undergo trial medical monitoring due to geographic, social or psychological reasons.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Curielead
Study Sites (3)
Institut Curie Paris
Paris, 75005, France
Institut Curie Saint-Cloud
Saint-Cloud, 92210, France
Gustave Roussy, Cancer Campus, Grand Paris
Villejuif, France
Related Publications (1)
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.
PMID: 39961716DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mary SAAD, MD
Institut Curie Saint-Cloud
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2022
First Posted
June 30, 2022
Study Start
December 7, 2022
Primary Completion (Estimated)
June 6, 2027
Study Completion (Estimated)
June 6, 2027
Last Updated
January 30, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data requests can be submitted starting 9 months after article publication and will be made accessible for up to 12 months.
- Access Criteria
- Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific reserach, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
Investigators will share de-identified data sets with interested researchers, educators or clinicians. Materials generated under the project will be disseminated in accordance with Institut Curie policies.