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A Study to Reduce Persistent Post-mastectomy Pain Using Opioid-free Anesthesia

Study acronym: RELIEF
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated November 21, 2025 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Phase: Phase 3 to Not applicablev4 Show 4 more changesShow less
    • Primary completion date: Oct 31, 2025 to Jul 31, 2026
    • Primary endpoint revised
    • Secondary endpoints revised (2)
    • Site details revised
  2. Primary completion date: Oct 31, 2024 to Oct 31, 2025
    • Study completion date: Oct 31, 2025 to Oct 31, 2027
    • Site details revised
    v3
  3. Start date changed from estimate of Dec 13, 2021 to Dec 16, 2021v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
In 230 patients undergoing mastectomy, the investigators will compare opioid-free anesthesia (OFA) versus conventional opioid-based anesthesia in terms of chronic pain. The enrolled patients will be randomly assigned into two groups with 1:1 ratio. Chronic pain will be evaluated at 1 year after mastectomy based on the Breast Cancer Pain Questionnaire (BCPQ). Baseline pain sensitivity test and psychologic evaluation will be done before operation.
Trial Details
NCT Number NCT05146778
Lead Sponsor Gangnam Severance Hospital
Conditions
(from sponsor)		 Breast Cancer, Mastectomy, Pain, Chronic, Pain, Post Operative
Related terms Breast Neoplasms, Chronic Pain, Postoperative Pain
Enrollment 230 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov