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NCT04766684 · ClinicalTrials.gov registry record · Phase 4
Comparison Study of LMX4 Cream Versus J-Tip Needle-Free Injection System With Lidocaine for In-Office PAT for Clubfoot
A Phase 4 study of Clubfoot, sponsored by Vanderbilt University Medical Center.
- Active
- Registry status
- Phase 4
- Development phase
- 94
- Enrollment target
- 1
- Study location
NCT04766684 is a Phase 4 study of Clubfoot that is active but no longer recruiting, run by Vanderbilt University Medical Center. The registered enrollment target is 94 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04766684, a Phase 4 study of Clubfoot, is active but no longer recruiting, sponsored by Vanderbilt University Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 94 participants
- Enrollment target
- 1
- Study location
Study Summary
Infants undergoing Ponseti treatment for idiopathic clubfoot often require percutaneous tendoachilles lengthening (TAL) after serial casting. This procedure is commonly performed in the office with a local anesthetic to avoid exposure to general anesthesia in the operating room. Topical anesthetic creams are commonly used to provide local analgesia for this procedure. The cream is applied to the infant's skin around the heel cord and requires 30-60 minutes to provide adequate analgesia, reaching a depth of up to 5 mm at maximum effect. Alternative to analgesic cream, the J-tip is a needle-free jet injection system that uses compressed CO2 instead of a needle to push 0.25 ml of lidocaine into the skin, providing local analgesia at the site of administration. This method likewise provides analgesia to the site of application at a depth of 5-8 mm, yet only takes approximately 1-2 minutes to achieve maximum effect. Aim 1: Determine which pain management method, L.M.X.4 Cream vs. J-tip 1% Xylocaine MPF Injection, provides the greatest pain relief to infants with clubfoot undergoing an in-office percutaneous TAL. Hypothesis: J-tip 1% Xylocaine MPF injection will provide equal or greater pain control when compared to L.M.X.4 cream in infants undergoing an in-office percutaneous TAL. Aim 2: Determine if there is a difference in the rate of adverse events between the two pain management methods, L.M.X.4 Cream vs. J-tip 1% Xylocaine MPF Injection. Hypothesis: J-tip 1% Xylocaine MPF injection will not be associated with an increased rate of adverse events in comparison to L.M.X.4 cream in infants undergoing an in-office percutaneous TAL. If J-tip Xylocaine MPF injection is shown to provide comparable or better pain control without an increase in adverse events, use of this needle-free injection system will decrease the overall length of visit and the cost of the procedure, thus increasing the quality, safety, and value.
Conditions Studied
Interventions
- DEVICE J-Tip with Xylocaine MPF with placebo cream
- DRUG L.M.X.4 cream with J-Tip saline injection
Study Locations (1)
Tennessee
- Vanderbilt Children's Orthopaedics - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2021-06-01 |
| Est. Completion | 2026-01-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04766684
The ClinicalTrials.gov registry entry for NCT04766684 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Clubfoot appearing as the primary indexed condition, and to 2 interventions - of which J-Tip with Xylocaine MPF with placebo cream is the first listed.
NCT04766684 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT04766684 about?
NCT04766684 is a clinical study titled "Comparison Study of LMX4 Cream Versus J-Tip Needle-Free Injection System With Lidocaine for In-Office PAT for Clubfoot". Infants undergoing Ponseti treatment for idiopathic clubfoot often require percutaneous tendoachilles lengthening (TAL) after serial casting. This procedure is commonly performed in the office with a local anesthetic to avoid exposure to general anesthesia in the operating room. Topical anesthetic c...
What is the current status of trial NCT04766684?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 94 participants. The study started on 2021-06-01. Estimated completion is 2026-01-01.
What conditions does trial NCT04766684 study?
This clinical trial studies the following conditions: Clubfoot.
What interventions are being tested in trial NCT04766684?
The interventions under investigation include: J-Tip with Xylocaine MPF with placebo cream (DEVICE), L.M.X.4 cream with J-Tip saline injection (DRUG).
Who is sponsoring clinical trial NCT04766684?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04766684 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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