Pain Management Methods for Clubfoot
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
Is the pain management method for clubfoot generally safe for humans?
The studies reviewed indicate that pain management methods, including local and topical anesthetics, are generally safe for procedures like Achilles tenotomy in infants, although high pain levels can occur despite multimodal pain relief. No significant safety concerns were reported in the studies for these methods.12345
How does the treatment for clubfoot using Percutaneous Tendoachilles Lengthening differ from other treatments?
Percutaneous Tendoachilles Lengthening for clubfoot is unique because it is an in-office procedure that typically uses local anesthesia, making it less invasive and more convenient compared to traditional surgical methods. This approach allows for quick recovery and minimal hospital stay, which is particularly beneficial for infants who commonly undergo this procedure.13678
What data supports the effectiveness of the treatment for Pain Management Methods for Clubfoot?
The Ponseti method, which includes percutaneous tendoachilles tenotomy, has shown excellent outcomes in managing clubfoot, with a study reporting 76.6% of cases having good results after one year. This suggests that the treatment is effective in correcting the equinus deformity associated with clubfoot.910111213
Who Is on the Research Team?
Jeffrey Martus, MD
Principal Investigator
Vanderbilt University Medical Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either L.M.X.4 Cream or J-Tip Xylocaine MPF injection for pain management during in-office percutaneous TAL
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- In-Office Procedure
- Needle-Free Injection System
- Pain Management
- Percutaneous Tendoachilles Lengthening
- Topical Anesthetic Cream
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor