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Pain Management Methods for Clubfoot

Phase 4

Waitlist Available

Led By Jeffrey Martus, MD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

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

Must have

Patients undergoing in-clinic Achilles Tenotomy

Clubfoot patients less than 6 weeks of age at start of casting

Must not have

Patients with a neuromuscular condition (spina bifida, caudal regression syndrome, arthrogryposis, etc.)

Clubfoot patients greater than 6 weeks of age at the start of casting

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, before cast placement to tenotomy procedure at the end of casting, approximately 10 weeks.

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing which pain management method, L.M.X.4 Cream vs. J-tip 1% Xylocaine MPF Injection, is better for infants with clubfoot undergoing an in-office percutaneous TAL. The hypothesis is that J-tip 1% Xylocaine MPF injection will provide equal or greater pain control when compared to L.M.X.4 cream.

Who is the study for?

This trial is for infants under 6 weeks old with idiopathic clubfoot who are getting in-clinic Achilles Tenotomy at Vanderbilt DOT 4 Clinic. It's not for those who've had previous clubfoot treatments, are older than 6 weeks at the start of casting, or have neuromuscular conditions like spina bifida.

What is being tested?

The study compares two pain relief methods during a foot procedure for clubfoot: LMX4 cream (a topical anesthetic) and J-Tip needle-free injection system with lidocaine. The goal is to see which provides better pain control without increasing adverse events.

What are the potential side effects?

Possible side effects may include skin reactions where the cream or injection was applied, such as redness or swelling. There might also be differences in how well each method controls pain during the procedure.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am scheduled for an Achilles tendon cutting procedure in a clinic.

Select...

My baby is under 6 weeks old and has clubfoot.

Exclusion Criteria

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

Select...

I have a condition affecting my muscles or nerves, like spina bifida.

Select...

I am over 6 weeks old and have clubfoot.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, before cast placement to tenotomy procedure at the end of casting, approximately 10 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, before cast placement to tenotomy procedure at the end of casting, approximately 10 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, before cast placement to tenotomy procedure at the end of casting, approximately 10 weeks. for reporting.