What side effects are associated with this type of intervention?

Common treatments for postoperative pain, such as lidocaine and other local anesthetics, can cause side effects including central nervous system symptoms (dizziness, headache, seizures) and cardiovascular issues (hypotension, bradycardia). Prolonged or high-dose infusions of lidocaine increase the risk of severe side effects, including toxicity. The severity of side effects for other local anesthetics depends on the dosage and duration of administration.

What prior FDA approvals exist?

The FDA has approved various formulations for the treatment of postoperative pain, including immediate-release and topical formulations of lidocaine. Lidocaine patches (e.g., Lidoderm) and topical gels have been used for localized pain relief. However, there is currently no FDA-approved injectable slow-release formulation of lidocaine like the one being studied in the trial ST-01. Other treatments for postoperative pain include nonsteroidal anti-inflammatory drugs (NSAIDs) and narcotic analgesics, which are commonly recommended for managing pain after surgeries.

What other types of research exist?

Promising alternatives to ST-01 for postoperative pain relief include: 1) A non-opioid analgesic implant for sustained intraperitoneal delivery of lidocaine, which has shown similar inflammatory responses to commercial silicone drains and is moving to human trials. 2) EN3427, a novel cationic aminoindane that provides long-lasting analgesia, especially when combined with lidocaine. 3) New transdermal lidocaine delivery systems designed for controlled release and enhanced local pain control.

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Local Anesthetic

Sustained Release Lidocaine for Postoperative Pain

Phase 2

Recruiting

Led By David Harriman, MD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Indication to undergo an operation with a planned pelvic incision

Be older than 18 years old

Must not have

Active infection involving the surgical site

Use of prohibited medications (quinidine, procainamide, disopyramide, lidocaine, mexiletine, flecainide, propafenone, amiodarone, dronedarone, ibutilide, dofetilide, sotalol, vernakalant)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new slow-release lidocaine formulation (ST-01) to manage pain after certain surgeries. It aims to provide longer-lasting pain relief and reduce the need for opioids. The medication is injected near the surgical site and releases lidocaine over time. Lidocaine has been used in various forms for pain management, including topical systems and systemic infusions, to reduce pain and opioid consumption.

Who is the study for?

This trial is for adults aged 19 or older who need surgery involving pelvic, perineal, or perianal incisions and can consent to study procedures. Participants must be willing to use birth control if sexually active. Those with allergies to lidocaine, heart issues, on certain medications (like antiarrhythmics), or with chronic pain conditions using opioids are excluded.

What is being tested?

The study is testing a new sustained release form of lidocaine called ST-01 against standard injections like Xylocaine® or Marcaine® for managing postoperative pain after specific surgeries. The goal is to see if ST-01 provides longer-lasting pain relief.

What are the potential side effects?

Potential side effects may include reactions at the injection site, allergic responses similar to other local anesthetics (such as itching or rash), and systemic effects like changes in blood pressure, numbness, and dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for surgery that involves an incision in the pelvic area.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have an infection at the site of my surgery.

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I am not taking any medications that are not allowed in the study.

Select...

I have chronic pain and use opioids or steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

To compare the intake of non-opioid analgesic medication by subjects after an injection of ST-01 or standard of care

To compare the intake of opioid analgesic medication by subjects after an injection of ST-01 or standard of care

To evaluate the safety of an injection of ST-01

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment (ST-01)Experimental Treatment1 Intervention

Administration of ST-01 as single-dose into the cutaneous, subcutaneous and fascia region of the surgical site and/or as nerve block.

Group II: Control (Standard of Care)Active Control1 Intervention

Administration of Control (Lidocaine Hydrochloride Injection USP Xylocaine® or Bupivacaine Hydrochloride Injection USP Marcaine®) as single-dose into the cutaneous, subcutaneous and fascia region of the surgical site and/or as nerve block.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Lidocaine, a local anesthetic, works by blocking sodium channels to inhibit nerve impulse conduction, providing pain relief. Sustained release formulations like ST-01 aim to extend this effect over multiple days, reducing the need for frequent dosing and improving patient comfort and compliance. This is crucial for postoperative pain patients as it ensures consistent pain management, reduces breakthrough pain, and minimizes reliance on systemic analgesics with more side effects.