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Sustained Release Lidocaine for the Treatment of Postoperative Pain

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

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.

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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

Resource links provided by the National Library of Medicine


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%)




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05193227


Contacts
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Contact: Genevive Moreau 604-875-4111 ext 67898 gbaloloy@prostatecentre.com
Contact: Jonathan Ma 604-875-5675

Locations
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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
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Principal Investigator: David Harriman, MD University of British Columbia
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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    Key Record Dates
Last Update Posted: January 14, 2022
Last Verified: December 2021

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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:
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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