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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
Any sex, aged ≥ 19 years
Stated willingness to comply with all study procedures and availability for the duration of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

Study Summary

This trial is testing a new, slow-release formulation of the drug lidocaine for its ability to manage postoperative pain after pelvic surgery.

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.Check my eligibility
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.See study design
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 19 years old or older.
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I am willing and able to follow all study rules and attend all appointments.
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I am scheduled for surgery that involves an incision in the pelvic area.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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
Secondary outcome measures
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

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.

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,410 Previous Clinical Trials
1,766,489 Total Patients Enrolled
5 Trials studying Postoperative Pain
1,012 Patients Enrolled for Postoperative Pain
Sustained Therapeutics Inc.Industry Sponsor
1 Previous Clinical Trials
63 Total Patients Enrolled
Graeme Boniface, PhDStudy DirectorSustained Therapeutics Inc.
1 Previous Clinical Trials
180 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still an opportunity to participate in this scientific investigation?

"According to the clinicaltrials.gov website, this research study is currently recruiting participants. The trial was originally announced on October 27th 2021 and has seen its last update occur on December 31st 2021."

Answered by AI

Could you provide the details of any preceding investigations centered around ST-01?

"Currently, 214 clinical trials are researching ST-01 with 48 of those studies in their final phase. Even though the main research hub is located in Germantown, Tennessee, 1225 different locations have been recruited to take part in these trials."

Answered by AI

What is the maximum capacity of patients taking part in this experiment?

"Affirmative. Records hosted on clinicaltrials.gov verify that this experiment, which was initially published on October 27th 2021, is currently recruiting volunteers. Approximately 120 participants have to be gathered from a single facility."

Answered by AI

Does the Food and Drug Administration recognize ST-01 as a viable medical treatment?

"Our team has assigned ST-01 a safety rating of 2, indicating that there is evidence to support its security profile but no clinical data validating the medication's efficacy."

Answered by AI

What ailments does ST-01 typically target?

"ST-01 is a common medical remedy for minor burns, but it may also be beneficial in treating lupus erythematosus cell, ulcerative colitis, and transplantation."

Answered by AI
~0 spots leftby Apr 2024