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

Study Overview
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Brief Summary
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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.

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

Conditions
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Trigger Finger

Intervention / Treatment
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* Procedure: Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley
* Drug: 2% Lidocaine
* Drug: Triamcinolone (20 g)
* Procedure: J-tip lidocaine administration
* Procedure: Triamcinolone (20 g) Injection over the A1 pulley.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Triamcinolone (20 g) and 2% Lidocaine injection over A1 pulley<br>Group one subjects will receive an injection of 0.5mL (20 g) of Triamcinolone and 0.5 mL of 2% Lidocaine over the A1 pulley. | Procedure: Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley<br> <br> Drug: 2% Lidocaine<br> <br> Drug: Triamcinolone (20 g)<br> <br> |
| Experimental: J-tip lidocaine administration, then steroid injection<br>Group two subjects will receive a needle free J-tip administration of 0.5mL of 2% lidocaine prior (2-10 minutes) to needle injection of 0.5mL of Triamcinolone (20 g) over the A1 pulley. | Drug: 2% Lidocaine<br> <br> Drug: Triamcinolone (20 g)<br> <br> Procedure: J-tip lidocaine administration<br> <br> Procedure: Triamcinolone (20 g) Injection over the A1 pulley.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Visual-analog Score (VAS) for Anticipated Pain Prior to Injection and Actual Pain After 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. | Our outcome measure was collected within the 60 seconds before and following the steroid injection. |