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

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorInstitut Curie

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine

    Drug

    Dexmedetomidine+Lidocaine

Treatment groups

158 Participants
are divided into 2 treatment groups
Group A: OFA groupExperimental treatment 1 intervention
Group B: CA control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

comparison of Morphine consumption in the two groups

Time frame
during the first 48 hours postoperatively

Secondary outcomes

1

Assessment of vasopressor requirement and total intraoperative filling volume

Time frame
end of surgery
2

Assessment of the state of consciousness on arrival in the PACU

Time frame
on arrival in the PACU
3

Assessment of the incidence of PONV in the PACU, at D0, D1 and D2

Time frame
in the PACU, at D0, D1 and D2
4

Maximum VAS at rest and mobilization in the PACU, at D0, D1 and D2

Time frame
in the PACU, at D0, D1 and D2

Other outcomes

Sponsors and contacts

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Institut Curie

Lead sponsor

Source ClinicalTrials.gov
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