Sustained Release Lidocaine for the Treatment of Postoperative Pain

A Randomized Phase 2 Trial of ST-01 (sustained-release Lidocaine Polymer Solution for Injection) in Subjects Undergoing Pelvic Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Postsurgical Pain
• Intervention / Treatment: Drug: ST-01; Drug: Control (Lidocaine Hydrochloride Injection USP Xylocaine® or Bupivacaine Hydrochloride Injection USP Marcaine®)

Detailed Description

The purpose of this study is to find out if a new sustained release lidocaine polymer formulation can provide effective postoperative pain control after surgery and lower opioid consumption.

A single dose of this new formulation ST-01 is administered as peri-neural injection and incisional deposition. The procedure is very comparable to the current standard of care procedure, where lidocaine solution (Lidocaine HCl 1% USP) is administered. However, the polymer solution ST-01 stays in the area of injection longer by forming a soft implant and could provide longer pain control.

The investigators' primary objective is to evaluate the efficacy of an injection of ST-01 to reduce subject-reported postoperative pain after surgery compared to standard of care. Secondary objectives are to determine the safety, frequency and total intake of opioid analgesic medication and frequency and total intake of non-opioid analgesic medication.

The clinical study is conducted at the Vancouver Prostate Centre and St. Paul's Hospital. Potential participants will undergo a screening period and will then be enrolled and randomized to either receive treatment (ST-01) or Control (Standard of Care) after surgery. Up to 120 study subjects will be enrolled and monitored over 30 days after surgery. Subjects will report their postsurgical pain and analgesic medication taken.

The primary endpoint and other continuous secondary endpoints will be compared with independent two-sample t-test if normally distributed and Wilcoxon rank-sum test if not normally distributed.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lesley Parker; Phone Number: 604 875 5594; Email: lparker@sustainedtx.com
• Study Contact Backup: Name: Graeme Boniface; Phone Number: 604-875-5594; Email: gboniface@prostatecentre.com

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Recruiting
      • Vancouver Prostate Centre
      • Contact: ST-CP-201 Study Clinical Trials Coordinator; Phone Number: 67898 604-875-4111; Email: clinic@ubcurology.com
      • Contact: Ryan Flannigan, MD
    • Vancouver, British Columbia, Canada, V7Z1Y6
      • Recruiting
      • St. Pauls Hospital
      • Contact: ST-CP-201 Study Clinical Trials Coordinator; Phone Number: 604 806 8711; Email: mobermayer@providencehealth.bc.ca
      • Contact: Amadeep Ghuman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: ST-01; Administration of up to 8 mL ST-01 (70 mg/mL lidocaine)
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.	Drug: 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%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the safety of an injection of ST-01	The incidence of treatment-emergent adverse events (TEAEs) and TEAEs related to the study treatment	30 days
To compare the intake of opioid analgesic medication by subjects after an injection of ST-01 or standard of care	The mean total postoperative opioid consumption through 3 days for ST-01 compared to SOC	3 days
To compare the intake of non-opioid analgesic medication by subjects after an injection of ST-01 or standard of care	The mean total postoperative non-opioid consumption through 3 days for ST-01 compared to SOC	3 days

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Sustained Therapeutics Inc.
• Investigators: Study Director: Graeme Boniface, PhD, Sustained Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2021
• Primary Completion (Estimated): April 27, 2026
• Study Completion (Estimated): May 27, 2026

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 31, 2021
• First Posted (Actual): January 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: hemorrhoidectomy; circumcision; pelvic surgery; scrotal surgery; inguinal incision; fistulotomy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Bupivacaine; Lidocaine
• Other Study ID Numbers: H20-00317

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No