Recruiting
Phase 2

Lidocaine

Sponsor:

University of British Columbia

Code:

NCT05193227

Conditions

Postoperative Pain

Postsurgical Pain

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

ST-01

Control (Lidocaine Hydrochloride Injection USP Xylocaine® or Bupivacaine Hydrochloride Injection USP Marcaine®)

Study Details

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.

Conditions

Postoperative Pain

Postsurgical Pain

Study ID

NCT05193227

Start date

Oct 27, 2021

Status verified date

Dec, 2024

Completion date

May 27, 2026

Anticipated

Primary completion date

Apr 27, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (ST-01)

Administration of ST-01 as single-dose into the cutaneous, subcutaneous and fascia region of the surgical site and/or as nerve block.

active comparator: Control (Standard of Care)

Administration of Control (Lidocaine Hydrochloride Injection USP Xylocaine® or Bupivacaine Hydrochloride Injection USP Marcaine®) as single-dose into the cutaneous, subcutaneous and fascia region of the surgical site and/or as nerve block.

Interventions

ST-01

Administration of up to 8 mL ST-01 (70 mg/mL lidocaine)

Control (Lidocaine Hydrochloride Injection USP Xylocaine® or Bupivacaine Hydrochloride Injection USP Marcaine®)

Administration of up to 3 mg/kg bupivacaine hydrochloride injection (0.25%) or up to 4.5mg/kg lidocaine hydrochloride injection (0.5-1%)

Primary outcome measure

  • To evaluate the efficacy of an injection of ST-01 to reduce subject-reported postoperative pain after surgery compared to standard of care [ Time Frame: 3 days ]

Central Contacts and Locations

Central contacts

Lesley Parker

604 875 5594lparker@sustainedtx.com

Graeme Boniface

604-875-5594gboniface@prostatecentre.com

Locations

Vancouver Prostate Centre

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

ST-CP-201 Study Clinical Trials Coordinator

604-875-4111clinic@ubcurology.com

St. Pauls Hospital

Recruiting

Vancouver, British Columbia, Canada, V7Z1Y6

Contacts

ST-CP-201 Study Clinical Trials Coordinator

604 806 8711mobermayer@providencehealth.bc.ca

Principal Investigator:

Amadeep Ghuman, MD

More Information

Sponsor

University of British Columbia

Last update posted

Feb 7, 2025

Last verified

Dec, 2024

Keywords

  • pelvic surgery
  • scrotal surgery
  • inguinal incision
  • circumcision
  • hemorrhoidectomy
  • fistulotomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2025-02-07.