Who is eligible for clinical trial NCT05193227?

Participants must meet protocol criteria for Postoperative Pain. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05193227 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-02-04

Sustained Release Lidocaine for the Treatment of Postoperative Pain (NCT05193227)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: University of British Columbia

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (8 items).

Location: Vancouver Prostate Centre — Vancouver, British Columbia

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Any sex, aged ≥ 19 years
Indication to undergo an operation with a planned pelvic incision
Able and willing to provide informed consent
Stated willingness to comply with all study procedures and availability for the duration of the study
If sexually active, is willing to use adequate birth control methods to prevent pregnancy over the course of the study

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
History of chronic pain conditions associated with the use of opioids or steroids
Known allergic reactions to any components of the investigational product
Active infection involving the surgical site
Any contraindication to local anesthesia with lidocaine (e.g., known hypersensitivity to anesthetics of the amide type, known hypokalemia, complete heart block, anticoagulants (ASA permitted) antiarrhythmic medication)
Use of prohibited medications (quinidine, procainamide, disopyramide, lidocaine, mexiletine, flecainide, propafenone, amiodarone, dronedarone, ibutilide, dofetilide, sotalol, vernakalant)
Has participated in another clinical trial within 3 months prior to the Screening Visit or is planning to participate in another clinical trial during this trial period
Has any other surgical or medical condition that, in the judgment of the clinical Investigator might warrant exclusion or be contraindicated for safety reason

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

Vancouver Prostate Centre — Vancouver, British Columbia
St. Pauls Hospital — Vancouver, British Columbia

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗