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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 Club Foot, sponsored by Vanderbilt University Medical Center.
- Active
- Registry status
- Phase 4
- Development phase
- 94
- Enrollment target
- 1
- Study location
NCT04766684: Active Phase 4 study of Club Foot, sponsored by Vanderbilt University Medical Center.
NCT04766684 is a Phase 4 study of Club Foot that is active but no longer recruiting, run by Vanderbilt University Medical Center. The registered enrollment target is 94 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04766684, a Phase 4 study of Club Foot, 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.
Primary Outcome
The FLACC scale is used to assess pain in children. For this study, it will be administered by the Certified Child Life Specialist. The Face, Legs, Activity, Cry, Consolability (FLACC) scale is a measurement used to assess pain in children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. Lower values represent reduced pain on the scale
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 |
What the registry record for NCT04766684 still lists
NCT04766684 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Club Foot 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 a single indexed study location in 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: Club Foot.
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.
Learn More About Clinical Trials
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Where NCT04766684's enrollment target sits among peer trials
94 871st of 2000 higher than 1,128 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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