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New treatment option for Postoperative Pain
Official title Sustained Release Lidocaine for the Treatment of Postoperative Pain
ClinicalTrials.gov ID: NCT05193227
What this study is testing
What is ST-01?
ST-01 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for postoperative pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Use of prohibited medications (quinidine, procainamide, disopyramide, lidocaine, mexiletine, flecainide, propafenone, amiodarone, dronedarone...
- Has participated in another clinical trial within 3 months prior to the Screening Visit or is planning to participate in another clinical trial...
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.