NCT05193227 Sustained Release Lidocaine for the Treatment of Postoperative Pain
| NCT ID | NCT05193227 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of British Columbia |
| Condition | Postoperative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2021-10-27 |
| Primary Completion | 2026-04-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2021-10-27 with a primary completion date of 2026-04-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 (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 Criteria
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
Contact & Investigator
Graeme Boniface, PhD
STUDY DIRECTOR
Sustained Therapeutics Inc.
Frequently Asked Questions
Who can join the NCT05193227 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Postoperative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05193227 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05193227 currently recruiting?
Yes, NCT05193227 is actively recruiting participants. Contact the research team at lparker@sustainedtx.com for enrollment information.
Where is the NCT05193227 trial being conducted?
This trial is being conducted at Vancouver, Canada, Vancouver, Canada.
Who is sponsoring the NCT05193227 clinical trial?
NCT05193227 is sponsored by University of British Columbia. The principal investigator is Graeme Boniface, PhD at Sustained Therapeutics Inc.. The trial plans to enroll 120 participants.