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Sustained Release Lidocaine for the Treatment of Postoperative Pain
Sponsor: University of British Columbia
Summary
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.
Official title: A Randomized Phase 2 Trial of ST-01 (Sustained-release Lidocaine Polymer Solution for Injection) in Subjects Undergoing Pelvic Surgery
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2021-10-27
Completion Date
2026-05-27
Last Updated
2025-02-07
Healthy Volunteers
No
Conditions
Interventions
ST-01
Administration of up to 8 mL ST-01 (70 mg/mL lidocaine)
Control (Lidocaine Hydrochloride Injection USP Xylocaine® or Bupivacaine Hydrochloride Injection USP Marcaine®)
Administration of up to 3 mg/kg bupivacaine hydrochloride injection (0.25%) or up to 4.5mg/kg lidocaine hydrochloride injection (0.5-1%)
Locations (2)
Vancouver Prostate Centre
Vancouver, British Columbia, Canada
St. Pauls Hospital
Vancouver, British Columbia, Canada