NCT05439005 Opioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.
| NCT ID | NCT05439005 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Institut Curie |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 158 participants |
| Start Date | 2022-12-07 |
| Primary Completion | 2027-06-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 158 participants in total. It began in 2022-12-07 with a primary completion date of 2027-06-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CA control group.
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.
Contact & Investigator
Mary SAAD, MD
STUDY DIRECTOR
Institut Curie Saint-Cloud
Frequently Asked Questions
Who can join the NCT05439005 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05439005 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 158 participants.
Is NCT05439005 currently recruiting?
Yes, NCT05439005 is actively recruiting participants. Contact the research team at anne-claire.coyne@curie.fr for enrollment information.
Where is the NCT05439005 trial being conducted?
This trial is being conducted at Paris, France, Saint-Cloud, France, Villejuif, France.
Who is sponsoring the NCT05439005 clinical trial?
NCT05439005 is sponsored by Institut Curie. The principal investigator is Mary SAAD, MD at Institut Curie Saint-Cloud. The trial plans to enroll 158 participants.
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