Pain
Conditions
Keywords
procedural
Brief summary
The objective of our study is to determine if technique of lidocaine administration can decrease pain perception. Hypothesis: There will be a significant difference in pain perception between patients who are given lidocaine on the skin surface prior to subcutaneous injection and patients who are given only subcutaneous injection by standard approach.
Detailed description
This is a single center prospective, randomized, blinded study assessing pain perception following 2 different lidocaine administration techniques in subjects who have planned medical procedures requiring local injection of lidocaine. Subjects will be approached and consented to participate in the study. They will be interviewed after the scheduled medical procedure to assess their pain using validated pain scores. An investigator who is not present for the procedure and blinded to the randomization will gather data regarding perceptions of pain from the entire procedure.
Interventions
DRUGlidocaine
2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients refered to the University of Chicago Medical Centers Procedure Service for a planned medical procedure requiring local injection of lidocaine.
Exclusion criteria
* Patient who lack decisional capacity to consent * Patients who lack the ability to answer questions in english using pain scales
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Assessment: Overall | post procedure (day 1) | Visual analog scale (VAS). This is a standardized analog scale with scores from 0-100. It measures level of pain with 0 meaning no pain and 100 meaning the most extreme level of pain. Higher values refer to a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Assessment: Lidocaine Injection | post procedure (day 1) | visual analog scale (VAS) 0= no pain to 100 = worse pain possible |
| Pain Assessment: During Procedure | post procedure (day 1) | visual analog scale (VAS) 0 = no pain to 100 = worse pain possible Rather, this is a pain assessment during the actual procedure rather than during the pre-procedure lidocaine injection. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection lidocaine: 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection. | 244 |
| Lidocaine Subcutaneous Injection Alone lidocaine: 1% lidocaine subcutaneous injection alone. | 237 |
| Total | 481 |
Baseline characteristics
| Characteristic | Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection | Lidocaine Subcutaneous Injection Alone | Total |
|---|---|---|---|
| Age, Continuous | 58.5 years | 56.8 years | 57.4 years |
| Race/Ethnicity, Customized african american | 90 Participants | 94 Participants | 184 Participants |
| Race/Ethnicity, Customized asian | 5 Participants | 3 Participants | 8 Participants |
| Race/Ethnicity, Customized other | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized white, hispanic | 10 Participants | 14 Participants | 24 Participants |
| Race/Ethnicity, Customized white, nonhispanic | 136 Participants | 123 Participants | 259 Participants |
| Sex: Female, Male Female | 120 Participants | 105 Participants | 225 Participants |
| Sex: Female, Male Male | 124 Participants | 132 Participants | 256 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 244 | 0 / 237 |
| other Total, other adverse events | 0 / 244 | 0 / 237 |
| serious Total, serious adverse events | 0 / 244 | 0 / 237 |
Outcome results
Primary
Pain Assessment: Overall
Visual analog scale (VAS). This is a standardized analog scale with scores from 0-100. It measures level of pain with 0 meaning no pain and 100 meaning the most extreme level of pain. Higher values refer to a worse outcome.
Time frame: post procedure (day 1)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection | Pain Assessment: Overall | 15.3 units on a scale | Standard Deviation 19.3 |
| Lidocaine Subcutaneous Injection Alone | Pain Assessment: Overall | 19.0 units on a scale | Standard Deviation 22.8 |
Secondary
Pain Assessment: During Procedure
visual analog scale (VAS) 0 = no pain to 100 = worse pain possible Rather, this is a pain assessment during the actual procedure rather than during the pre-procedure lidocaine injection.
Time frame: post procedure (day 1)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection | Pain Assessment: During Procedure | 12.2 units on a scale | Standard Deviation 19.4 |
| Lidocaine Subcutaneous Injection Alone | Pain Assessment: During Procedure | 16.6 units on a scale | Standard Deviation 24.8 |
Secondary
Pain Assessment: Lidocaine Injection
visual analog scale (VAS) 0= no pain to 100 = worse pain possible
Time frame: post procedure (day 1)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection | Pain Assessment: Lidocaine Injection | 18.4 units on a scale | Standard Deviation 21.2 |
| Lidocaine Subcutaneous Injection Alone | Pain Assessment: Lidocaine Injection | 20.8 units on a scale | Standard Deviation 23.5 |