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Clinical Trials in Canada / NCT05193227
Recruiting Phase 2

Sustained Release Lidocaine for the Treatment of Postoperative Pain

NCT05193227 · tracked via the Priya Life Science Canada tracker
Phase
Phase 2
Started
2021-10-27
Last updated
2025-02-07

Condition(s) studied

Postoperative PainPostsurgical Pain

Investigational drug(s) / intervention(s)

ST-01Control (Lidocaine Hydrochloride Injection USP Xylocaine® or Bupivacaine Hydrochloride Injection USP Marcaine®)

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%)

Study 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

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Vancouver Prostate Centre Vancouver British Columbia Recruiting
St. Pauls Hospital Vancouver British Columbia Recruiting

More University of British Columbia trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05193227 on ClinicalTrials.gov ↗ ← All trials in Canada