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Comparison Study of LMX4 Cream Versus J-Tip Needle-Free Injection System With Lidocaine for In-Office PAT for Clubfoot

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ClinicalTrials.gov Identifier: NCT04766684
Recruitment Status : Recruiting
First Posted : February 23, 2021
Last Update Posted : October 1, 2021
Sponsor:
Information provided by (Responsible Party):
Jeffrey Martus, Vanderbilt University Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Clubfoot Device: J-Tip with Xylocaine MPF with placebo cream Drug: L.M.X.4 cream with J-Tip saline injection Phase 4

Detailed Description:

Clubfoot is a common congenital birth deformity, with a prevalence of 1 in 1000 live births. If left untreated, clubfoot can cause significant disability. Treatment of clubfoot has evolved over several decades and now favors the method of serial casting pioneered by Ignacio Ponseti. This technique involves weekly stretching followed by application of a long leg cast. In the majority of cases, percutaneous tendoachilles lengthening (TAL) is required to correct the equinus component of the clubfoot deformity. Following TAL, a long leg cast is applied for 3 weeks and then a foot-abduction orthosis is utilized to maintain correction of the deformity.

Percutaneous TAL can be performed in the operating room under general anesthesia or in an outpatient setting utilizing local or topical anesthesia. While studies have shown that in-office percutaneous TAL is safe and efficient, little has been done to investigate the pain management strategies implemented for infants during this procedure. Pain management for infants during procedures is important because it has been shown that repeated painful exposures during early stages of life can lead to alterations in hemodynamic stability, altered stress hormone expression, heightened peripheral sensitivity, altered pain reactivity that persists following the painful stimulus, and somatization. One study identified the infant's ability to become conditioned to painful stimuli, such as heel sticks, at as early as 3 days old. Based on this, providers should be prepared to provide adequate pain management for infants during painful procedures, such as in-office TAL, by utilizing non-pharmaceutical techniques, pharmaceutical techniques, or a combination of both.

Needle injection of local anesthetic is generally avoided prior to an in-office percutaneous TAL due to the needle puncture and the concern that soft tissue swelling may prevent accurate palpation of the heel cord during the procedure. As such, topical local 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. At our institution, a 5 gram tube of L.M.X.4 cream costs $4.12, while other studies report that a larger 25 gram tube of EMLA cream can cost as much as $56, with the excess being wasted. Alternative to anesthetic 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 provides analgesia to the site of application at a depth of 5-8 mm and takes approximately 5 minutes to achieve maximum effect. At our institution, the cost of the J-tip applicator and a 20 mL 1% lidocaine vial is $5.11. Multiple studies have demonstrated the J-Tip to provide greater pain control than other pharmaceutical options, including EMLA cream and vapocoolant ("freezy") spray.

The goal of this study is to determine if the J-Tip Xylocaine MPF injection provides equal or greater pain control in clubfoot patients undergoing an in-office percutaneous TAL when compared to L.M.X.4 cream, without an increase in adverse events. If this is true, use of J-tip Xylocaine MPF injection will decrease the overall time and cost of the visit, while ultimately increasing the quality, safety, and value of in-office TAL for the treatment of clubfoot in infants.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

On the day of or after the final casting visit, the participant will be randomized in equal proportion (1:1) to either the control group (receive L.M.X.4 cream with J-Tip saline injection) or the intervention group (placebo cream with J-Tip with 0.25mL of 1% Xylocaine MPF). Researchers, physicians, nurses, CCLS, caregivers, and patients will be blinded to which group the patient is assigned to. The only person who will remain unblinded is the research coordinator.

An outside pharmacy, the Health & Wellness Compounding Pharmacy, will provide and blind the L.M.X.4 and placebo creams. The Vanderbilt Investigational Drug Service will provide the blinded J-Tip 1% Xylocaine MPF and saline vials. The Investigational Drug Service will store the creams provided by the outside pharmacy and the J-Tip vials. They will assist in dispensing the creams/vials to the outpatient clinic.

Primary Purpose: Treatment
Official Title: A Randomized, Comparison Study of L.M.X.4 Cream Versus J-Tip Needle-Free Injection System With Lidocaine in Children Undergoing In-Office Percutaneous Achilles Tenotomy for Clubfoot
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: J-Tip with 0.25mL of 1% Xylocaine MPF with placebo cream Device: J-Tip with Xylocaine MPF with placebo cream
J-Tip with 0.25mL of 1% Xylocaine MPF with placebo cream

Active Comparator: L.M.X.4 cream with J-Tip saline injection Drug: L.M.X.4 cream with J-Tip saline injection
L.M.X.4 cream with J-Tip saline injection




Primary Outcome Measures :
  1. FLACC (Face, Legs, Activity, Cry, Consolability) Scale [ Time Frame: Baseline, before cast placement to tenotomy procdure at the end of casting, approximately 10 weeks. ]
    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 lessening pain on the scale

  2. Pulse Oximetry [ Time Frame: Baseline, before cast placement to tenotomy procdure at the end of casting, approximately 10 weeks. ]
    Pulse oximetry will be used to measure oxygen levels in the blood. An oxygen saturation level of 95 percent is considered normal



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Clubfoot patients less than 6 weeks of age at start of casting
  • Patients presenting to Vanderbilt DOT 4 Clinic for care
  • Patients undergoing in-clinic Achilles Tenotomy

Exclusion Criteria

  • Clubfoot patients greater than 6 weeks of age at the start of casting
  • Previous clubfoot treatment
  • Patients with a neuromuscular condition (spina bifida, caudal regression syndrome, arthrogryposis, etc.)
  • In-office TAL is not recommended by treating physician due to patient factors such as age or size

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04766684


Contacts
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Contact: Brooke Turner 615-936-1357 brooke.turner@vumc.org
Contact: Jeffrey Martus, MD 615-343-5875 Jeff.Martus@vumc.org

Locations
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United States, Tennessee
Vanderbilt Children's Orthopaedics Recruiting
Nashville, Tennessee, United States, 37232
Contact: Brooke E Turner, BA    615-936-1357    brooke.turner@vumc.org   
Contact: Jeffrey Martus, MD    6153435875    Jeff.Martus@vumc.org   
Principal Investigator: Jeffry Martus, MD         
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Jeffrey Martus, MD Vanderbilt University Medical Center
  Study Documents (Full-Text)

Documents provided by Jeffrey Martus, Vanderbilt University Medical Center:
Informed Consent Form  [PDF] June 28, 2021

Publications:

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Responsible Party: Jeffrey Martus, Associate Professor of Orthopaedic Surgery and Rehabilitation, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT04766684    
Other Study ID Numbers: 200842
First Posted: February 23, 2021    Key Record Dates
Last Update Posted: October 1, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not currently a plan to share IPD with other researchers.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Jeffrey Martus, Vanderbilt University Medical Center:
Clubfoot
J-Tip
Additional relevant MeSH terms:
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Clubfoot
Talipes
Equinus Deformity
Foot Deformities
Foot Deformities, Acquired
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action