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Needle-Free Injection of Lidocaine for Local Anesthesia Prior to Trigger Digit Injection (J-tip)

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ClinicalTrials.gov Identifier: NCT02084706
Recruitment Status : Completed
First Posted : March 12, 2014
Results First Posted : October 28, 2016
Last Update Posted : December 12, 2016
Sponsor:
Information provided by (Responsible Party):
Philip Blazar, MD, 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.


Condition or disease Intervention/treatment Phase
Trigger Finger 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. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Needle-Free Injection of Lidocaine for Local Anesthesia Prior to Trigger Digit Injection
Study Start Date : March 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : June 2015

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Arm Intervention/treatment
Active Comparator: Triamcinolone (20 g) and 2% Lidocaine injection over 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.
Procedure: Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley
Drug: 2% Lidocaine
Drug: Triamcinolone (20 g)
Experimental: J-tip lidocaine administration, then steroid injection
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.



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02084706


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Philip E Blazar, MD Brigham and Women's Hospital

Publications:

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Responsible Party: Philip Blazar, MD, Associate Professor, Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02084706     History of Changes
Other Study ID Numbers: 2013P002370
First Posted: March 12, 2014    Key Record Dates
Results First Posted: October 28, 2016
Last Update Posted: December 12, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Trigger Finger Disorder
Tendon Entrapment
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Lidocaine
Triamcinolone diacetate
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors