Informations générales (source: ClinicalTrials.gov)
Opioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study. (OFOBA)
Interventional
Phase 3
Institut Curie (Voir sur ClinicalTrials)
décembre 2022
mars 2026
29 juin 2024
This study will compare morphine consumption during the first 48 hours postoperatively
between the OFA group and the CA control group.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:41 | Contacter | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Migena DEMIRI | 10/04/2024 13:25:06 | Contacter | ||
| CLCC RENE HUGUENIN INSTITUT CURIE | 04/09/2024 13:49:28 | Contacter | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Gustave Roussy, Cancer Campus, Grand Paris - Villejuif - France | Migena DEMIRI, MD | Contact (sur clinicalTrials) | |||
Critères
Femme
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.
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.
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.