Sustained Release Lidocaine for the Treatment of Postoperative Pain
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of British Columbia
About this trial
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
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- ST-01
- Control (Lidocaine Hydrochloride Injection USP Xylocaine® or Bupivacaine Hydrochloride Injection USP Marcaine®)
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of British Columbia
Lead sponsor
Sustained Therapeutics Inc.
Collaborator
Source ClinicalTrials.gov