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

Trigger Finger Clinical Trial

— J-tip  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02084706
• Other study ID #: 2013P002370
• Status: Active, not recruiting
• Phase: N/A
• First received: March 5, 2014
• Last updated: February 11, 2015
• Start date: March 2014
• Est. completion date: July 2015

Study information

• Verified date: February 2015
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 128
• Est. completion date: July 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Trigger Finger
• Trigger Finger Disorder

Intervention

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

Drug:
• 2% Lidocaine

• Triamcinolone (20 g)

Procedure:
• J-tip lidocaine administration

• Triamcinolone (20 g) Injection over the A1 pulley.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (8)

Ferayorni A, Yniguez R, Bryson M, Bulloch B. Needle-free jet injection of lidocaine for local anesthesia during lumbar puncture: a randomized controlled trial. Pediatr Emerg Care. 2012 Jul;28(7):687-90. doi: 10.1097/PEC.0b013e31825d210b. — View Citation

Jimenez N, Bradford H, Seidel KD, Sousa M, Lynn AM. A comparison of a needle-free injection system for local anesthesia versus EMLA for intravenous catheter insertion in the pediatric patient. Anesth Analg. 2006 Feb;102(2):411-4. — View Citation

Kolind-Sorensen V. Treatment of trigger fingers. Acta Orthop Scand. 1970;41(4):428-32. — View Citation

Lapidus PW, Guidotti FP. Stenosing tenovaginitis of the wrist and fingers. Clin Orthop Relat Res. 1972 Mar-Apr;83:87-90. — View Citation

Lysakowski C, Dumont L, Tramèr MR, Tassonyi E. A needle-free jet-injection system with lidocaine for peripheral intravenous cannula insertion: a randomized controlled trial with cost-effectiveness analysis. Anesth Analg. 2003 Jan;96(1):215-9, table of contents. — View Citation

Murphy D, Failla JM, Koniuch MP. Steroid versus placebo injection for trigger finger. J Hand Surg Am. 1995 Jul;20(4):628-31. Erratum in: J Hand Surg [Am] 1995 Nov;20(6):1075. — View Citation

Rhoades CE, Gelberman RH, Manjarris JF. Stenosing tenosynovitis of the fingers and thumb. Results of a prospective trial of steroid injection and splinting. Clin Orthop Relat Res. 1984 Nov;(190):236-8. — View Citation

Spanos S, Booth R, Koenig H, Sikes K, Gracely E, Kim IK. Jet Injection of 1% buffered lidocaine versus topical ELA-Max for anesthesia before peripheral intravenous catheterization in children: a randomized controlled trial. Pediatr Emerg Care. 2008 Aug;24(8):511-5. doi: 10.1097/PEC.0b013e31816a8d5b. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual-analog score (VAS)	Group one subjects will then receive an injection of 0.5mL of 40 mg/ml triamcinolone and 0.5 mL of 2% Lidocaine over the A1 pulley; group two subjects will receive a J-tip administration of 0.5mL of 2% lidocaine prior (2-10 minutes) to needle injection of 0.5mL of 40 mg/ml triamcinolone. Members of both groups will then complete the Visual Analog Scale pain assessment; this recorded score is the primary study endpoint.	Our outcome measure will be collected within the 60 seconds following the steroid injection.	No