Trial Outcomes & Findings for Comparison of Two Lidocaine Administration Techniques (NCT NCT01330134)
NCT ID: NCT01330134
Last Updated: 2018-07-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
481 participants
Primary outcome timeframe
post procedure (day 1)
Results posted on
2018-07-26
Participant Flow
Participant milestones
| Measure |
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.
|
Lidocaine Subcutaneous Injection Alone
lidocaine: 1% lidocaine subcutaneous injection alone.
|
|---|---|---|
|
Overall Study
STARTED
|
244
|
237
|
|
Overall Study
COMPLETED
|
244
|
237
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Two Lidocaine Administration Techniques
Baseline characteristics by cohort
| Measure |
Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection
n=244 Participants
lidocaine: 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection.
|
Lidocaine Subcutaneous Injection Alone
n=237 Participants
lidocaine: 1% lidocaine subcutaneous injection alone.
|
Total
n=481 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.5 years
n=99 Participants
|
56.8 years
n=107 Participants
|
57.4 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=99 Participants
|
105 Participants
n=107 Participants
|
225 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
124 Participants
n=99 Participants
|
132 Participants
n=107 Participants
|
256 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
white, nonhispanic
|
136 Participants
n=99 Participants
|
123 Participants
n=107 Participants
|
259 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
white, hispanic
|
10 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
african american
|
90 Participants
n=99 Participants
|
94 Participants
n=107 Participants
|
184 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
asian
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
other
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection
n=244 Participants
lidocaine: 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection.
|
Lidocaine Subcutaneous Injection Alone
n=237 Participants
lidocaine: 1% lidocaine subcutaneous injection alone.
|
|---|---|---|
|
Pain Assessment: Overall
|
15.3 units on a scale
Standard Deviation 19.3
|
19.0 units on a scale
Standard Deviation 22.8
|
SECONDARY outcome
Timeframe: post procedure (day 1)visual analog scale (VAS) 0= no pain to 100 = worse pain possible
Outcome measures
| Measure |
Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection
n=244 Participants
lidocaine: 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection.
|
Lidocaine Subcutaneous Injection Alone
n=237 Participants
lidocaine: 1% lidocaine subcutaneous injection alone.
|
|---|---|---|
|
Pain Assessment: Lidocaine Injection
|
18.4 units on a scale
Standard Deviation 21.2
|
20.8 units on a scale
Standard Deviation 23.5
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection
n=244 Participants
lidocaine: 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection.
|
Lidocaine Subcutaneous Injection Alone
n=237 Participants
lidocaine: 1% lidocaine subcutaneous injection alone.
|
|---|---|---|
|
Pain Assessment: During Procedure
|
12.2 units on a scale
Standard Deviation 19.4
|
16.6 units on a scale
Standard Deviation 24.8
|
Adverse Events
Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lidocaine Subcutaneous Injection Alone
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place