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NCT Number: NCT05439005

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

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Institut Curie Paris, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

Dexmedetomidine

Drug

Dexmedetomidine+Lidocaine

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

  5. Dose of morphine given in titration in the PACU (mg)

    Time frame: in the PACU

  6. Number of boluses demand on PCA during the first 48 hours postoperatively

    Time frame: the first 48 hours postoperatively

  7. DN3 score (Neuropathic Pain 3) on D2, D4, M1, M3 and M6

    Time frame: on D2, D4, M1, M3 and M6

  8. Length of stay in PACU (h) and length of in-hospital postoperative length of stay (D)

    Time frame: at discharge

  9. Assessment of the flap failure rate (flap removal surgery) and flap micro-anastomosis re-exploration rate

    Time frame: at discharge

  10. Pain management satisfaction scores (score from 0 to 10) at discharge

    Time frame: at discharge

  11. Collection of serious adverse events between D0 (date of surgery) and D30

    Time frame: between D0 (date of surgery) and D30

  12. Dose of intraoperative rescue remifentanil in the OFA group (mcg)

    Time frame: at discharge

  13. Morphine consumption during the first 48 hours post-operatively (mg) in each breast reconstruction subgroup (immediate and secondary);

    Time frame: the first 48 hours postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Claire COYNE, PhD

CONTACT

[email protected]

0033156245765

Mary SAAD, MD

CONTACT

[email protected]

0033147112371

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Acronym: OFOBA

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jun 30, 2022
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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