Status:
RECRUITING
Sustained Release Lidocaine for the Treatment of Postoperative Pain
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Sustained Therapeutics Inc.
Conditions:
Postoperative Pain
Postsurgical Pain
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief 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 (hemorrhoidectom...
Detailed Description
The purpose of this study is to find out if a new sustained release lidocaine polymer formulation can provide effective postoperative pain control after surgery and lower opioid consumption. A single...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 27 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05193227
Start Date
October 27 2021
End Date
May 27 2026
Last Update
February 7 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Vancouver Prostate Centre
Vancouver, British Columbia, Canada, V5Z 1M9
2
St. Pauls Hospital
Vancouver, British Columbia, Canada, V7Z1Y6