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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.

Study acronym: OFOBA
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Primary and study completion dates: Mar 15, 2026 to Jun 6, 2027v11
  2. Re-verified, no change to tracked fieldsv10
  3. Secondary endpoints: 12 to 13
    • Site contacts updated at 1 of 3 sites
    • Eligibility criteria shortened, about 1 word
    • Study title shortened, about 1 word
    v9
  4. Re-verified, no change to tracked fieldsv8
  5. Site details revised at 2 of 3 sitesv7
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  1. Site contacts updated at 1 of 3 sitesv6
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of Dec 15, 2022 to Dec 7, 2022
    v5
  3. Start date: Sep 15, 2022 to Dec 15, 2022v4
  4. Secondary endpoints expanded, about 144 wordsv3
  5. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Institut Curie
43 trials monitored
See 1 trial at risk
Breast Cancer
5,418 trials monitored
See 296 trials at risk
This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CA control group.
Trial Details
NCT Number NCT05439005
Lead Sponsor Institut Curie
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 158 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov