Recruiting NCT05439005

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

Phase III Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Dexmedetomidine.
Who it may be relevant to: Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: France
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CA control group.

comparison of Morphine consumption in the two groups [Time frame: during the first 48 hours postoperatively]

Secondary outcome measures (12)

Assessment of vasopressor requirement and total intraoperative filling volume [Time frame: end of surgery]
Assessment of the state of consciousness on arrival in the PACU [Time frame: on arrival in the PACU]
Assessment of the incidence of PONV in the PACU, at D0, D1 and D2 [Time frame: in the PACU, at D0, D1 and D2]
Maximum VAS at rest and mobilization in the PACU, at D0, D1 and D2 [Time frame: in the PACU, at D0, D1 and D2]
Dose of morphine given in titration in the PACU (mg) [Time frame: in the PACU]
Number of boluses demand on PCA during the first 48 hours postoperatively [Time frame: the first 48 hours postoperatively]
DN3 score (Neuropathic Pain 3) on D2, D4, M1, M3 and M6 [Time frame: on D2, D4, M1, M3 and M6]
Length of stay in PACU (h) and length of in-hospital postoperative length of stay (D) [Time frame: at discharge]
Assessment of the flap failure rate (flap removal surgery) and flap micro-anastomosis re-exploration rate [Time frame: at discharge]
Pain management satisfaction scores (score from 0 to 10) at discharge [Time frame: at discharge]
Collection of serious adverse events between D0 (date of surgery) and D30 [Time frame: between D0 (date of surgery) and D30]
Dose of intraoperative rescue remifentanil in the OFA group (mcg) [Time frame: at discharge]

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

France · 3 centers

Saad-Boutry M, Carton M, Ezzili C, Savignoni A. Opioid-free versus opioid-based anaesthesia for free-flap reconstruction surgery of the breast: protocol for a phase III, multicentre, randomised controlled study. BMJ Open. 2025 Feb 17;15(2):e070021. doi: 10.1136/bmjopen-2022-070021. PMID 39961716

NCT: NCT05439005 · IC 2021-07