Sustained Release Lidocaine for the Treatment of Postoperative Pain

• Status: Recruiting
• Trial end date: 2023-05-27
• Target enrollment: 0
• Participant gender: All

Summary

In this study, the investigators are testing a new formulation of lidocaine for its suitability in managing postoperative pain after pelvic surgery. 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Treatments: Bupivacaine; Lidocaine

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