RecruitingPhase 2NCT05193227

Sustained Release Lidocaine for the Treatment of Postoperative Pain

A Randomized Phase 2 Trial of ST-01 (Sustained-release Lidocaine Polymer Solution for Injection) in Subjects Undergoing Pelvic Surgery


Sponsor

University of British Columbia

Enrollment

120 participants

Start Date

Oct 27, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Control (Lidocaine Hydrochloride Injection USP Xylocaine® or Bupivacaine Hydrochloride Injection USP Marcaine®) and a drug called ST-01 for people with postoperative pain and postsurgical pain. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 19 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGST-01

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

DRUGControl (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

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NCT05193227


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