Sustained Release Lidocaine for the Treatment of Postoperative Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05193227|
Recruitment Status : Recruiting
First Posted : January 14, 2022
Last Update Posted : January 14, 2022
|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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|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|
Experimental: Treatment (ST-01)
Peri-neural injection and incisional deposition of 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%)
- 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).
- 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
- 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
- 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
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
|Contact: Genevive Moreau||604-875-4111 ext email@example.com|
|Contact: Jonathan Ma||604-875-5675|
|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|
|Principal Investigator:||David Harriman, MD||University of British Columbia|