Trigger Finger
Conditions
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.
Interventions
PROCEDURETriamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley
DRUG2% Lidocaine
PROCEDUREJ-tip lidocaine administration
PROCEDURETriamcinolone (20 g) Injection over the A1 pulley.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Visual-analog Score (VAS) for Anticipated Pain Prior to Injection and Actual Pain After Injection | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 29 |
| 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. | 31 |
| Total | 60 |
Baseline characteristics
| Characteristic | J-tip Lidocaine Administration, Then Steroid Injection | Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 17 Participants | 33 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 12 Participants | 27 Participants |
| Age, Continuous | 65.4 years STANDARD_DEVIATION 10.3 | 66.3 years STANDARD_DEVIATION 11.2 | 65.8 years STANDARD_DEVIATION 10.6 |
| Gender Female | 17 Participants | 17 Participants | 34 Participants |
| Gender Male | 14 Participants | 12 Participants | 26 Participants |
| Region of Enrollment United States | 31 Participants | 29 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 0 / 31 |
| serious Total, serious adverse events | 0 / 29 | 0 / 31 |
Outcome results
Primary
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.
Time frame: Our outcome measure was collected within the 60 seconds before and following the steroid injection.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Triamcinolone (20 g) and 2% Lidocaine Injection Over 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 |
| J-tip Lidocaine Administration, Then Steroid Injection | Difference in Visual-analog Score (VAS) for Anticipated Pain Prior to Injection and Actual Pain After Injection | 2.8 units on a scale | Standard Deviation 0.39 |