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Sustained Release Lidocaine for the Treatment of Postoperative Pain

RecruitingPhase 2Ages 19 Years - anyAllUniversity of British Columbia
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

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

2 sites
Vancouver Prostate Centre
Vancouver, Canada
St. Pauls Hospital
Vancouver, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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