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

Last updated: April 4, 2024
Sponsor: Institut Curie
Overall Status: Active - Recruiting

Phase

3

Condition

Breast Cancer

Cancer

Treatment

Dexmedetomidine

Clinical Study ID

NCT05439005
IC 2021-07
  • Ages > 18
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Women aged 18 or older.
  2. Patients with a French health insurance coverage (having a French social securitynumber).
  3. Patient eligible for free flap reconstruction surgery of the breastunder generalanaesthesia.
  4. Patient who has given written consent to participate in accordance with theregulations.
  5. Having a negative blood pregnancy test for patients of childbea ring age.

Exclusion

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/orsevere 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 analgesicspreoperatively.
  9. Patient already included in another therapeutic trial evaluating an experimentalmolecule.
  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 orpsychological reasons.

Study Design

Total Participants: 158
Treatment Group(s): 1
Primary Treatment: Dexmedetomidine
Phase: 3
Study Start date:
December 07, 2022
Estimated Completion Date:
March 15, 2026

Connect with a study center

  • Institut Curie Paris

    Paris, 75005
    France

    Active - Recruiting

  • Institut Curie Saint-Cloud

    Saint-Cloud, 92210
    France

    Active - Recruiting

  • Gustave Roussy, Cancer Campus, Grand Paris

    Villejuif,
    France

    Active - Recruiting

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