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

January 28, 2026 updated by: Institut Curie
This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CA control group.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

158

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75005
        • Recruiting
        • Institut Curie Paris
        • Contact:
        • Principal Investigator:
          • jane Muret, MD
      • Saint-Cloud, France, 92210
        • Recruiting
        • Institut Curie Saint-Cloud
        • Contact:
        • Principal Investigator:
          • Mary SAAD, MD
      • Villejuif, France
        • Recruiting
        • Gustave Roussy, Cancer Campus, Grand Paris
        • Contact:
        • Principal Investigator:
          • Migena DEMIRI, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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 childbea ring age.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OFA group
OFA (Opioid Free Anaesthesia) group:
Drug: Dexmedetomidine
Dexmedetomidine+Lidocaine
No Intervention: CA control group
CA (Conventional Anaesthesia) control group:

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
comparison of Morphine consumption in the two groups
Time Frame: during the first 48 hours postoperatively
during the first 48 hours postoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Curie

Investigators

  • Study Director: Mary SAAD, MD, Institut Curie Saint-Cloud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2022

Primary Completion (Estimated)

June 6, 2027

Study Completion (Estimated)

June 6, 2027

Study Registration Dates

First Submitted

June 27, 2022

First Submitted That Met QC Criteria

June 27, 2022

First Posted (Actual)

June 30, 2022

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC 2021-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Investigators will share de-identified data sets with interested researchers, educators or clinicians. Materials generated under the project will be disseminated in accordance with Institut Curie policies.

IPD Sharing Time Frame

Data requests can be submitted starting 9 months after article publication and will be made accessible for up to 12 months.

IPD Sharing Access Criteria

Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific reserach, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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