Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    16428534 [PUBMED-IDS]
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant)
Condition 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.
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley J-tip Lidocaine Administration, Then Steroid Injection
Hide Arm/Group Description

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 the A1 pulley

2% Lidocaine

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.

2% Lidocaine

Triamcinolone (20 g)

J-tip lidocaine administration

Triamcinolone (20 g) Injection over the A1 pulley.

Period Title: Overall Study
Started 29 31
Completed 29 31
Not Completed 0 0
Arm/Group Title Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley J-tip Lidocaine Administration, Then Steroid Injection Total
Hide Arm/Group Description

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 the A1 pulley

2% Lidocaine

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.

2% Lidocaine

Triamcinolone (20 g)

J-tip lidocaine administration

Triamcinolone (20 g) Injection over the A1 pulley.

Total of all reporting groups
Overall Number of Baseline Participants 29 31 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 31 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
  41.4%
15
  48.4%
27
  45.0%
>=65 years
17
  58.6%
16
  51.6%
33
  55.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 31 participants 60 participants
66.3  (11.2) 65.4  (10.3) 65.8  (10.6)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 31 participants 60 participants
Female
17
  58.6%
17
  54.8%
34
  56.7%
Male
12
  41.4%
14
  45.2%
26
  43.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 29 participants 31 participants 60 participants
29
 100.0%
31
 100.0%
60
 100.0%
1.Primary Outcome
Title Difference in Visual-analog Score (VAS) for Anticipated Pain Prior to Injection and Actual Pain After Injection
Hide Description 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.
Time Frame Our outcome measure was collected within the 60 seconds before and following the steroid injection.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley J-tip Lidocaine Administration, Then Steroid Injection
Hide Arm/Group Description:

Group one subjects received 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 the A1 pulley

2% Lidocaine

Triamcinolone (20 g)

Group two subjects received 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.

2% Lidocaine

Triamcinolone (20 g)

J-tip lidocaine administration

Triamcinolone (20 g) Injection over the A1 pulley.

Overall Number of Participants Analyzed 29 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.6  (0.44) 2.8  (0.39)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley J-tip Lidocaine Administration, Then Steroid Injection
Hide Arm/Group Description

Group one subjects received 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 the A1 pulley

2% Lidocaine

Triamcinolone (20 g)

Group two subjects received 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.

2% Lidocaine

Triamcinolone (20 g)

J-tip lidocaine administration

Triamcinolone (20 g) Injection over the A1 pulley.

All-Cause Mortality
Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley J-tip Lidocaine Administration, Then Steroid Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley J-tip Lidocaine Administration, Then Steroid Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/31 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley J-tip Lidocaine Administration, Then Steroid Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/31 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Philip Blazar
Organization: Brigham and Women's Hospital
Phone: 617-732-5384
Publications:
Responsible Party: Philip Blazar, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02084706     History of Changes
Other Study ID Numbers: 2013P002370
First Submitted: March 5, 2014
First Posted: March 12, 2014
Results First Submitted: July 20, 2016
Results First Posted: October 28, 2016
Last Update Posted: December 12, 2016