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Trial record 1 of 2 for:    16428534 [PUBMED-IDS]
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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

Tracking Information
First Submitted Date  ICMJE March 5, 2014
First Posted Date  ICMJE March 12, 2014
Results First Submitted Date  ICMJE July 20, 2016
Results First Posted Date  ICMJE October 28, 2016
Last Update Posted Date December 12, 2016
Study Start Date  ICMJE March 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 10, 2014)
Visual-analog score (VAS) [ Time Frame: Our outcome measure will be collected within the 60 seconds following the steroid injection. ]
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.
Change History Complete list of historical versions of study NCT02084706 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Needle-Free Injection of Lidocaine for Local Anesthesia Prior to Trigger Digit Injection
Official Title  ICMJE Needle-Free Injection of Lidocaine for Local Anesthesia Prior to Trigger Digit Injection
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Condition  ICMJE Trigger Finger
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • 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.
    Interventions:
    • Drug: 2% Lidocaine
    • Drug: Triamcinolone (20 g)
    • Procedure: J-tip lidocaine administration
    • Procedure: Triamcinolone (20 g) Injection over the A1 pulley.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 7, 2016)
60
Original Estimated Enrollment  ICMJE
 (submitted: March 10, 2014)
128
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02084706
Other Study ID Numbers  ICMJE 2013P002370
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Philip Blazar, MD, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philip E Blazar, MD Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP