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Completed

NCT Number: NCT02084706

Needle-Free Injection of Lidocaine for Local Anesthesia Prior to Trigger Digit Injection

Jet-injection (J-tip) is a rapid, minimally invasive delivery system that can be used for the subdermal injection of lidocaine solution for anesthetic purposes. The device has been found effective in pain reduction during IV catheterization in adults and children and lumbar puncture in children when compared to placebo saline-jet injection. [1-4].

We believe that administering local anesthetic via J-tip prior to triamcinolone(40 mg/ml) injection could mitigate pain that occurs during and immediately following injection while preserving the post-injection pain relief of anesthetic injection. Furthermore, pre-placement of the jet-injected local anesthetic may obviate the need for the inclusion of local anesthetic into the triamcinolone injection. This would decrease the amount of fluid injected, which could have positive pain modulation by decreased tissue disruption.

Objective: To evaluate the effectiveness of needle free jet injection (J-tip) administration of 2% lidocaine in reduction of the pain experienced during trigger digit 40 mg/ml triamcinolone injection.

Hypothesis: Needle free jet injection (J-tip) administration of 2% lidocaine will prove an equal or superior means of pain reduction when compared to 2% lidocaine injection in the setting of trigger digit triamcinolone injections.

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Key information

Conditions

Trigger Finger Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Entrapment Trigger Finger Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who present to the Hand Clinic at Brigham and Women's Hospital or Brigham and Women's Faulkner Hospital, are 18 years of age or older and are indicated for a trigger digit steroid injection will be eligible for participation

Treatment and study plan

Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley

Procedure

2% lidocaine

Drug

Triamcinolone (20 g)

Drug

J-tip lidocaine administration

Procedure

Triamcinolone (20 g) Injection over the A1 pulley.

Procedure

Primary outcomes

  1. Difference in Visual-analog Score (VAS) for Anticipated Pain Prior to Injection and Actual Pain After Injection

    Time frame: Our outcome measure was collected within the 60 seconds before and following the steroid injection.

    Members of both study groups completed the Visual Analog Scale (VAS) pain assessment both prior for anticipated pain and after injection for actual pain; these recorded scores were the primary study endpoint and were later compared to determine the difference in anticipated pain versus actual pain experienced. The VAS ranges from 0-10, where 0 is no pain and 10 is worst possible pain. The outcome measure is the mean anticipated pain minus the actual pain experienced.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Acronym: J-tip

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 12, 2014
Registry last updated
Dec 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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