Sustained Release Lidocaine for the Treatment of Postoperative Pain

Sponsor

University of British Columbia (Other)

Overall Status

Recruiting

CT.gov ID

NCT05193227

Collaborator

(none)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

6.3

Patients Per Site Per Month

Study Details

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

Anticipated 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 :

Oct 27, 2021

Anticipated Primary Completion Date :

Apr 27, 2023

Anticipated 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%)

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

To evaluate the efficacy of an injection of ST-01 to reduce subject-reported postoperative pain after surgery compared to standard of care [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

To evaluate the safety of an injection of ST-01 [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 [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 [3 days]
The mean total postoperative non-opioid consumption through 3 days for ST-01 compared to SOC

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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