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

Not Applicable

Completed

Conditions: Trigger Finger

Interventions: 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.

Registration Number: NCT02084706

Lead Sponsor: Brigham and Women's Hospital

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

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

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Triamcinolone (20 g) and 2% Lidocaine injection over A1 pulley	Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley	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.
Triamcinolone (20 g) and 2% Lidocaine injection over A1 pulley	2% Lidocaine	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.
Triamcinolone (20 g) and 2% Lidocaine injection over A1 pulley	Triamcinolone (20 g)	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.
J-tip lidocaine administration, then steroid injection	2% Lidocaine	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.
J-tip lidocaine administration, then steroid injection	Triamcinolone (20 g)	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.
J-tip lidocaine administration, then steroid injection	J-tip lidocaine administration	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.
J-tip lidocaine administration, then steroid injection	Triamcinolone (20 g) Injection over the A1 pulley.	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.

Primary Outcome Measures

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

Secondary Outcome Measures