94 Participants Needed

Pain Management Methods for Clubfoot

JM
JM
BT
Overseen ByBrooke Turner
Age: < 18
Sex: Any
Trial Phase: Phase 4
Sponsor: Vanderbilt University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

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.12345

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.678910

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.68111213

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.

Research Team

JM

Jeffrey Martus, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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

I am scheduled for an Achilles tendon cutting procedure in a clinic.
My baby is under 6 weeks old and has clubfoot.
Patients presenting to Vanderbilt DOT 4 Clinic for care

Exclusion Criteria

My doctor advises against certain throat procedures due to my age or size.
I have a condition affecting my muscles or nerves, like spina bifida.
You have had treatment for clubfoot in the past.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either L.M.X.4 Cream or J-Tip Xylocaine MPF injection for pain management during in-office percutaneous TAL

10 weeks
Weekly visits for casting and procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • In-Office Procedure
  • Needle-Free Injection System
  • Pain Management
  • Percutaneous Tendoachilles Lengthening
  • Topical Anesthetic Cream
Trial Overview 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: J-Tip with 0.25mL of 1% Xylocaine MPF with placebo creamExperimental Treatment1 Intervention
Group II: L.M.X.4 cream with J-Tip saline injectionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

References

Safety of percutaneous tendoachilles tenotomy performed under general anesthesia on infants with idiopathic clubfoot. [2022]
Outcome of Percutaneous Tenotomy in the Management of Congenital Talipes Equino Varus by Ponseti Method. [2018]
Comparative results of percutaneous Achilles tenotomy to combined open Achilles tenotomy with posterior capsulotomy in the correction of equinus deformity in congenital talipes equinovarus. [2018]
Bleeding complications following percutaneous tendoachilles tenotomy in the treatment of clubfoot deformity. [2022]
Radiographic evaluation of idiopathic clubfeet undergoing Ponseti treatment. [2016]
Sedation protocols for Ponseti clubfoot Achilles tenotomy. [2022]
PROSPECT guideline for hallux valgus repair surgery: a systematic review and procedure-specific postoperative pain management recommendations. [2021]
Procedural Pain Management During Tenotomy for Congenital Talipes Equinovarus. [2023]
Peripheral Nerve Blockade in Total Hip Arthroplasty: A Retrospective Study with Propensity Score Matching. [2023]
Outcomes of a Modified Arthroscopic-assisted Reconstruction Technique for Lateral Ankle Instability. [2022]
How effective is periarticular drug infiltration in providing pain relief and early functional outcome following total hip arthroplasty? [2022]
[Preemptive local anesthetic infiltration in hallux valgus one-day surgery]. [2015]
Pain relief after major ankle and hindfoot surgery with repetitive peripheral nerve blocks: A feasibility study. [2023]
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