Opioid-Free versus Opioid-Based Anaesthesia for secondary free-flap reconstruction surgery of the breast: A phase III multicentric randomized controlled study

Phase 1

Conditions: Anaesthesia during secondary free flap reconstruction surgery of the breast.
MedDRA version: 21.1Level: LLTClassification code 10002323Term: Anesthesia generalSystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 20.0Level: PTClassification code 10006305Term: Breast reconstructionSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2022-001139-98-FR

Lead Sponsor: Institut Curie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 158

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 secondary 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 childbearing age.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 158
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 158

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.