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

NCT02084706 | Completed Results DMC

• 1 other identifier: 2013P002370
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Trigger Finger

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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

ACTIVE COMPARATOR

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; Drug: 2% Lidocaine; Drug: Triamcinolone (20 g)

J-tip lidocaine administration, then steroid injection

EXPERIMENTAL

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; Drug: Triamcinolone (20 g); Procedure: J-tip lidocaine administration; Procedure: Triamcinolone (20 g) Injection over the A1 pulley.

Interventions

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

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

2% Lidocaine DRUG

J-tip lidocaine administration, then steroid injection; Triamcinolone (20 g) and 2% Lidocaine injection over A1 pulley

Triamcinolone (20 g) DRUG

J-tip lidocaine administration, then steroid injection; Triamcinolone (20 g) and 2% Lidocaine injection over A1 pulley

J-tip lidocaine administration PROCEDURE

J-tip lidocaine administration, then steroid injection

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

J-tip lidocaine administration, then steroid injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (8)

• Lysakowski C, Dumont L, Tramer 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. doi: 10.1097/00000539-200301000-00044.

  PMID: 12505955 BACKGROUND

• 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.

  PMID: 22743744 BACKGROUND

• 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. doi: 10.1213/01.ane.0000194293.10549.62.

  PMID: 16428534 BACKGROUND

• 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.

  PMID: 18645542 BACKGROUND

• Kolind-Sorensen V. Treatment of trigger fingers. Acta Orthop Scand. 1970;41(4):428-32. doi: 10.3109/17453677008991530. No abstract available.

  PMID: 5537268 BACKGROUND

• Lapidus PW, Guidotti FP. Stenosing tenovaginitis of the wrist and fingers. Clin Orthop Relat Res. 1972 Mar-Apr;83:87-90. doi: 10.1097/00003086-197203000-00015. No abstract available.

  PMID: 5014835 BACKGROUND

• 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.

  PMID: 6488636 BACKGROUND

• Murphy D, Failla JM, Koniuch MP. Steroid versus placebo injection for trigger finger. J Hand Surg Am. 1995 Jul;20(4):628-31. doi: 10.1016/S0363-5023(05)80280-1.

  PMID: 7594291 BACKGROUND

MeSH Terms

Conditions

Trigger Finger Disorder

Interventions

Triamcinolone; Lidocaine

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Philip Blazar
• Organization: Brigham and Women's Hospital

pblazar@partners.org

617-732-5384

Study Officials

• Philip E Blazar, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Harvard Medical School

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 12, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 12, 2016
• Results First Posted: October 28, 2016

Record last verified: 2016-10

Locations

US (1)