Opioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.
- Registration Number
- NCT05439005
- Lead Sponsor
- Institut Curie
- Brief Summary
This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CA control group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 158
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OFA group Dexmedetomidine OFA (Opioid Free Anaesthesia) group:
- Primary Outcome Measures
Name Time Method comparison of Morphine consumption in the two groups during the first 48 hours postoperatively
- Secondary Outcome Measures
Name Time Method Maximum VAS at rest and mobilization in the PACU, at D0, D1 and D2 in the PACU, at D0, D1 and D2 Pain management satisfaction scores (score from 0 to 10) at discharge at discharge Morphine consumption during the first 48 hours post-operatively (mg) in each breast reconstruction subgroup (immediate and secondary); the first 48 hours postoperatively Dose of morphine given in titration in the PACU (mg) in the PACU DN3 score (Neuropathic Pain 3) on D2, D4, M1, M3 and M6 on D2, D4, M1, M3 and M6 Collection of serious adverse events between D0 (date of surgery) and D30 between D0 (date of surgery) and D30 Assessment of the flap failure rate (flap removal surgery) and flap micro-anastomosis re-exploration rate at discharge Dose of intraoperative rescue remifentanil in the OFA group (mcg) at discharge 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 Number of boluses demand on PCA during the first 48 hours postoperatively the first 48 hours postoperatively Assessment of the incidence of PONV in the PACU, at D0, D1 and D2 in the PACU, at D0, D1 and D2 Length of stay in PACU (h) and length of in-hospital postoperative length of stay (D) at discharge
Trial Locations
- Locations (3)
Institut Curie Saint-Cloud
🇫🇷Saint-Cloud, France
Gustave Roussy, Cancer Campus, Grand Paris
🇫🇷Villejuif, France
Institut Curie Paris
🇫🇷Paris, France