Sustained Release Lidocaine for the Treatment of Postoperative Pain
NCT ID: NCT05193227
Last Updated: 2025-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2021-10-27
2026-05-27
Brief Summary
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Detailed Description
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A single dose of this new formulation ST-01 is administered as peri-neural injection and incisional deposition. The procedure is very comparable to the current standard of care procedure, where lidocaine solution (Lidocaine HCl 1% USP) is administered. However, the polymer solution ST-01 stays in the area of injection longer by forming a soft implant and could provide longer pain control.
The investigators' primary objective is to evaluate the efficacy of an injection of ST-01 to reduce subject-reported postoperative pain after surgery compared to standard of care. Secondary objectives are to determine the safety, frequency and total intake of opioid analgesic medication and frequency and total intake of non-opioid analgesic medication.
The clinical study is conducted at the Vancouver Prostate Centre and St. Paul's Hospital. Potential participants will undergo a screening period and will then be enrolled and randomized to either receive treatment (ST-01) or Control (Standard of Care) after surgery. Up to 120 study subjects will be enrolled and monitored over 30 days after surgery. Subjects will report their postsurgical pain and analgesic medication taken.
The primary endpoint and other continuous secondary endpoints will be compared with independent two-sample t-test if normally distributed and Wilcoxon rank-sum test if not normally distributed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment (ST-01)
Administration of ST-01 as single-dose into the cutaneous, subcutaneous and fascia region of the surgical site and/or as nerve block.
ST-01
Administration of up to 8 mL ST-01 (70 mg/mL lidocaine)
Control (Standard of Care)
Administration of Control (Lidocaine Hydrochloride Injection USP Xylocaine® or Bupivacaine Hydrochloride Injection USP Marcaine®) as single-dose into the cutaneous, subcutaneous and fascia region of the surgical site and/or as nerve block.
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%)
Interventions
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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%)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
ALL
No
Sponsors
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Sustained Therapeutics Inc.
INDUSTRY
University of British Columbia
OTHER
Responsible Party
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David Harriman
Assistant Professor, Department of Urologic Sciences
Principal Investigators
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Graeme Boniface, PhD
Role: STUDY_DIRECTOR
Sustained Therapeutics Inc.
Locations
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Vancouver Prostate Centre
Vancouver, British Columbia, Canada
St. Pauls Hospital
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H20-00317
Identifier Type: -
Identifier Source: org_study_id
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