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Clinical Trial

Clubfoot Tenotomy Trial

NCT: NCT04766684 · COMPLETED

NCT IDNCT04766684
StatusCOMPLETED
Start Date2021-06-01
Completion2024-08-01

Brief Summary

Infants undergoing Ponseti treatment for idiopathic clubfoot often require percutaneous tendoachilles lengthening (TAL) after serial casting. This procedure is frequently 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 achilles tendon and requires 30 minutes to provide adequate analgesia, reaching a depth of up to 5 mm at maximum effect. An alternative is a needle-free jet injection system that uses compressed CO2 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, topical anesthetic cream (4% liposomal lidocaine) vs. jet infection of local anesthesia (1% lidocaine), provides the greatest pain relief to infants with clubfoot undergoing an in-office percutaneous TAL. Hypothesis: Jet injection will provide equal or greater pain control when compared topical anesthetic cream. Aim 2: Determine if there is a difference in the rate of adverse events between the two pain management methods, topical anesthetic cream (4% liposomal lidocaine) vs. jet infection of local anesthesia (1% lidocaine). Hypothesis: Jet injection of local anesthesia will not be associated with an increased rate of adverse events in comparison to topical anesthetic cream. If jet injection of local anesthesia 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 the procedure visit, thus increasing quality, safety, and value.

Frequently Asked Questions

What is Clubfoot Tenotomy Trial?

Clubfoot Tenotomy Trial is a clinical trial registered under NCT04766684. Current status: COMPLETED.

What is the status of NCT04766684?

The current status of NCT04766684 (Clubfoot Tenotomy Trial) is: COMPLETED.

When did Clubfoot Tenotomy Trial start?

Clubfoot Tenotomy Trial started on 2021-06-01.

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.