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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Administration of up to 8 mL ST-01 (70 mg/mL lidocaine)
Administration of up to 3 mg/kg bupivacaine hydrochloride injection (0.25%) or up to 4.5mg/kg lidocaine hydrochloride injection (0.5-1%)
Vancouver Prostate Centre
Vancouver, British Columbia, Canada
RECRUITINGSt. Pauls Hospital
Vancouver, British Columbia, Canada
RECRUITINGTo 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).
Time frame: 3 days
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
Time frame: 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
Time frame: 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
Time frame: 3 days
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Enrollment
120