Postoperative Pain Clinical Trial
Official title:
A Randomized Phase 2 Trial of ST-01 (Sustained-release Lidocaine Polymer Solution for Injection) in Subjects Undergoing Pelvic Surgery
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | May 27, 2024 |
Est. primary completion date | April 27, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | St. Pauls Hospital | Vancouver | British Columbia |
Canada | Vancouver Prostate Centre | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | Sustained Therapeutics Inc. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the efficacy of an injection of ST-01 to reduce subject-reported postoperative pain after surgery compared to standard of care | The mean area under the curve (AUC) of the visual analogue scale (VAS) of pain intensity scores through day 3 (AUC0-3) for ST-01 compared with standard of care (SOC). | 3 days | |
Secondary | To evaluate the safety of an injection of ST-01 | The incidence of treatment-emergent adverse events (TEAEs) and TEAEs related to the study treatment | 30 days | |
Secondary | To compare the intake of opioid analgesic medication by subjects after an injection of ST-01 or standard of care | The mean total postoperative opioid consumption through 3 days for ST-01 compared to SOC | 3 days | |
Secondary | To compare the intake of non-opioid analgesic medication by subjects after an injection of ST-01 or standard of care | The mean total postoperative non-opioid consumption through 3 days for ST-01 compared to SOC | 3 days |
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