Sustained Release Lidocaine for the Treatment of Postoperative Pain

NCT05193227 | Recruiting Phase 2 DMC

• 1 other identifier: H20-00317
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of an injection of ST-01 to reduce subject-reported postoperative pain after surgery compared to standard of care

  The mean area under the curve (AUC) of the visual analogue scale (VAS) of pain intensity scores through day 3 (AUC0-3) for ST-01 compared with standard of care (SOC).

  3 days

Secondary Outcomes (3)

• To evaluate the safety of an injection of ST-01

  30 days

• To compare the intake of opioid analgesic medication by subjects after an injection of ST-01 or standard of care

  3 days

• To compare the intake of non-opioid analgesic medication by subjects after an injection of ST-01 or standard of care

  3 days

Study Arms (2)

Treatment (ST-01)

EXPERIMENTAL

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

Drug: ST-01

Control (Standard of Care)

ACTIVE COMPARATOR

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.

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

Interventions

ST-01 DRUG

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

Treatment (ST-01)

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

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

Control (Standard of Care)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Sustained Therapeutics Inc.: collaborator

Study Sites (2)

Vancouver Prostate Centre

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

St. Pauls Hospital

Vancouver, British Columbia, V7Z1Y6, Canada

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Graeme Boniface, PhD

  Sustained Therapeutics Inc.

  STUDY DIRECTOR

Central Study Contacts

Lesley Parker

CONTACT

604 875 5594; lparker@sustainedtx.com

Graeme Boniface

CONTACT

604-875-5594; gboniface@prostatecentre.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Urologic Sciences

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: January 14, 2022
• Study Start: October 27, 2021
• Primary Completion: April 27, 2026
• Study Completion (Estimated): May 27, 2026
• Last Updated: February 7, 2025

Record last verified: 2024-12

Locations

CA (2)