Sustained Release Lidocaine for the Treatment of Postoperative Pain

• ClinicalTrials.gov Identifier: NCT05193227
• Recruitment Status: Recruiting
• First Posted: January 14, 2022
• Last Update Posted: January 14, 2022
• Sponsor: University of British Columbia
• Information provided by (Responsible Party): David Harriman, University of British Columbia

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Postoperative Pain; Postsurgical Pain	Drug: ST-01; Drug: Control (Lidocaine HCl Injection USP Xylocaine® or Bupivacaine HCl Injection USP Marcaine®)	Phase 2

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. 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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Randomized Phase 2 Trial of ST-01 (Sustained-release Lidocaine Polymer Solution for Injection) in Subjects Undergoing Pelvic Surgery
• Actual Study Start Date: October 27, 2021
• Estimated Primary Completion Date: April 27, 2023
• Estimated Study Completion Date: May 27, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment (ST-01); Peri-neural injection and incisional deposition of ST-01	Drug: ST-01; Administration of up to 8 mL ST-01 (70 mg/mL lidocaine)
Active Comparator: Control (Standard of Care); Incisional deposition of Lidocaine HCl Injection USP Xylocaine® or Bupivacaine HCl Injection USP Marcaine®	Drug: Control (Lidocaine HCl Injection USP Xylocaine® or Bupivacaine HCl 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%)

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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).

Secondary Outcome Measures :

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

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Genevive Moreau; 604-875-4111 ext 67898; gbaloloy@prostatecentre.com

Contact: Jonathan Ma; 604-875-5675

Locations

Canada, British Columbia

Department of Urologic Sciences, Gordon & Leslie Diamond Health Care Centre; Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contact: Genevive Moreau 604-875-4111 ext 67898

Sub-Investigator: Ryan Flannigan, MD

Sponsors and Collaborators

University of British Columbia

Investigators

• Principal Investigator: David Harriman, MD; University of British Columbia

More Information

• Responsible Party: David Harriman, Assistant Professor, Department of Urologic Sciences, University of British Columbia
• ClinicalTrials.gov Identifier: NCT05193227
• Other Study ID Numbers: H20-00317
• First Posted: January 14, 2022
• Last Update Posted: January 14, 2022
• Last Verified: December 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David Harriman, University of British Columbia:

pelvic surgery; scrotal surgery; inguinal incision; circumcision

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Lidocaine; Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action