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Sustained Release Lidocaine for the Treatment of Postoperative Pain

StatusRecruiting
PhasePhase 2
Started
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Record status
This record was last updated February 7, 2025 (before its estimated April 27, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Apr 27, 2024 to Apr 27, 2026
    • Study completion date: May 27, 2024 to May 27, 2026
    v3
  2. Primary completion date: Apr 27, 2023 to Apr 27, 2024v2 Show 5 more changesShow less
    • Study sites: 1 to 2
    • Study completion date: May 27, 2023 to May 27, 2024
    • Interventions: Control (Lidocaine HCl Injection USP Xylocaine® or Bupivacaine HCl Injection USP Marcaine®) (Drug), ST-01 (Drug) to Control (Lidocaine Hydrochloride Injection USP Xylocaine® or Bupivacaine Hydrochloride Injection USP Marcaine®) (Drug), ST-01 (Drug)
    • Study description expanded, about 4 words
    • Collaborators expanded, about 3 words
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 this study, the investigators are testing a new formulation of lidocaine for its suitability in managing postoperative pain after pelvic (circumcision, inguinal, scrotal), perineal (hemorrhoidectomy) or perianal (fistulotomy) incisions. The new formulation ST-01 is a sustained release lidocaine formulation and is expected to provide pain relief over multiple days. Currently, the drug lidocaine is not available as an injectable slow-release formulation.
Trial Details
NCT Number NCT05193227
Lead Sponsor University of British Columbia
Collaborators: Sustained Therapeutics Inc.
Conditions
(from sponsor)		 Postoperative Pain, Postsurgical Pain
Related terms Postoperative Pain
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov