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
University of British Columbia
120 participants
Oct 27, 2021
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
Inclusion Criteria5
- 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 Criteria7
- 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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Interventions
Administration of up to 8 mL ST-01 (70 mg/mL lidocaine)
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05193227