OFOBA: Opioid Free Versus Opioid Based Anaesthesia for Secondary Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.
Study Details
Study Description
Brief Summary
This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CGA control group.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: OFA group OFA (Opioid Free Anaesthesia) group: |
Drug: Dexmedetomidine
Dexmedetomidine+Lidocaine
|
| No Intervention: CGA control group CGA (Conventional General Anaesthesia) control group: |
Outcome Measures
Primary Outcome Measures
- comparison of Morphine consumption in the two groups [during the first 48 hours postoperatively]
Secondary Outcome Measures
- 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]
- Number of boluses demand on PCA during the first 48 hours postoperatively [the first 48 hours postoperatively]
- DN4 score (Neuropathic Pain 4) on D2, D4, M1, M3 and M6 [on D2, D4, M1, M3 and M6]
- Length of stay in PACU (h) and length of in-hospital postoperative length of stay (D) [at discharge]
- Assessment of the flap failure rate (flap removal surgery) and flap micro-anastomosis re-exploration rate [at discharge]
- Pain management satisfaction scores (score from 0 to 10) at discharge [at discharge]
- Collection of serious adverse events between D0 (date of surgery) and D30 [between D0 (date of surgery) and D30]
- Dose of intraoperative rescue remifentanil in the OFA group (mcg) [at discharge]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Women aged 18 or older.
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Patients with a French health insurance coverage (having a French social security number).
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Patient eligible for secondary free flap reconstruction surgery of the breastunder general anaesthesia.
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Patient who has given written consent to participate in accordance with the regulations.
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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).
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Known history of heart failure, arrhythmias and/or ischemic heart disease and/or severe renal insufficiency.
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Pulse below 50bpm during anaesthesia consultation and/or under beta blocker treatment.
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Treatment with ACEI/ARB.
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Severe asthma.
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Symptomatic gastric or duodenal ulcer with or without treatment.
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Baseline systolic blood pressure < 100 mmHg.
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Chronic preoperative pain and/or use of WHO ladder step 2 or 3 analgesics preoperatively.
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Patient already included in another therapeutic trial evaluating an experimental molecule.
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Persons deprived of liberty or under guardianship.
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Patients with suspected difficulties in assessing pain on a scale.
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Inability to undergo trial medical monitoring due to geographic, social or psychological reasons.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Institut Curie
Investigators
- Principal Investigator: Mary SAAD, MD, MSc, Institut Curie Saint-Cloud
- Principal Investigator: ACIKGOZ Hans, MD, Institut Curie Paris
- Principal Investigator: Migena DEMIRI, MD, Gustave Roussy, Cancer Campus, Grand Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IC 2021 07