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RECRUITING
NCT05193227
PHASE2

Sustained Release Lidocaine for the Treatment of Postoperative Pain

Sponsor: University of British Columbia

View on ClinicalTrials.gov

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

Interventions

DRUG

ST-01

Administration of up to 8 mL ST-01 (70 mg/mL lidocaine)

DRUG

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