Trial Outcomes & Findings for Needle-Free Injection of Lidocaine for Local Anesthesia Prior to Trigger Digit Injection (NCT NCT02084706)

NCT ID: NCT02084706

Last Updated: 2016-12-12

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: Our outcome measure was collected within the 60 seconds before and following the steroid injection.
• Results posted on: 2016-12-12

Participant Flow

Participant milestones

Measure	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. Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley 2% Lidocaine Triamcinolone (20 g)	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. 2% Lidocaine Triamcinolone (20 g) J-tip lidocaine administration Triamcinolone (20 g) Injection over the A1 pulley.
Overall Study STARTED	29	31
Overall Study COMPLETED	29	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley n=29 Participants 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)	J-tip Lidocaine Administration, Then Steroid Injection n=31 Participants 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 n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Age, Continuous	66.3 years STANDARD_DEVIATION 11.2 • n=5 Participants	65.4 years STANDARD_DEVIATION 10.3 • n=7 Participants	65.8 years STANDARD_DEVIATION 10.6 • n=5 Participants
Gender Female	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Gender Male	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment United States	29 Participants n=5 Participants	31 Participants n=7 Participants	60 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley n=29 Participants 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)	J-tip Lidocaine Administration, Then Steroid Injection n=31 Participants 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.
Difference in Visual-analog Score (VAS) for Anticipated Pain Prior to Injection and Actual Pain After Injection	1.6 units on a scale Standard Deviation 0.44	2.8 units on a scale Standard Deviation 0.39

Adverse Events

Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

J-tip Lidocaine Administration, Then Steroid Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Philip Blazar

Brigham and Women's Hospital

Phone: 617-732-5384

Email: pblazar@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place