Actively Recruiting
Sustained Release Lidocaine for the Treatment of Postoperative Pain
Led by University of British Columbia · Updated on 2025-02-07
120
Participants Needed
2
Research Sites
239 weeks
Total Duration
On this page
Sponsors
U
University of British Columbia
Lead Sponsor
S
Sustained Therapeutics Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sustained Release Lidocaine for the Treatment of Postoperative Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any sex, aged 19 years or older
- Scheduled for surgery with a planned pelvic incision
- Able and willing to provide informed consent
- Willing to comply with study procedures and be available for the study duration
- If sexually active, willing to use effective birth control during the study
You will not qualify if you...
- History of chronic pain conditions treated with opioids or steroids
- Known allergy to any components of the study drug
- Active infection at the surgical site
- Contraindications to local anesthesia with lidocaine (e.g., hypersensitivity to amide anesthetics, hypokalemia, complete heart block, use of certain antiarrhythmic medications)
- Use of prohibited medications like quinidine, procainamide, disopyramide, lidocaine, mexiletine, flecainide, propafenone, amiodarone, dronedarone, ibutilide, dofetilide, sotalol, vernakalant
- Participation in another clinical trial within 3 months before screening or planned participation during this trial
- Any other medical or surgical condition that may pose safety risks or contraindications as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Vancouver Prostate Centre
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
2
St. Pauls Hospital
Vancouver, British Columbia, Canada, V7Z1Y6
Actively Recruiting
Research Team
L
Lesley Parker
CONTACT
G
Graeme Boniface
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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