Opioid Free Versus Opioid Based Anaesthesia for Secondary Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.

Study Overview
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Brief Summary
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This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CGA control group.

Official Title
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Opioid Free Versus Opioid Based Anaesthesia for Secondary Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 18 or older. Patients with a French health insurance coverage (having a French social security number). Patient eligible for secondary 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OFA group<br>OFA (Opioid Free Anaesthesia) group: | Drug: Dexmedetomidine<br>* Dexmedetomidine+Lidocaine<br>|
| No Intervention: CGA control group<br>CGA (Conventional General Anaesthesia) control group: | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of Morphine consumption in the two groups |  | during the first 48 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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free flap reconstruction surgery, anaesthesia