Comparison of Two Lidocaine Administration Techniques

• Sponsor: University of Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT01330134
• Collaborator: (none)
• Enrollment: 481
• Location: 1
• Arms: 2
• Duration (Months): 49.9
• Patients Per Site Per Month: 9.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: lidocaine; Drug: lidocaine	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 481 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of Two Lidocaine Administration Techniques
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: lidocaine onto skin prior to lidocaine subcutaneous injection 1-2ml of 1% lidocaine dripped onto the surface of the skin immediately prior to subcutaneous injection of 1% lidocaine.	Drug: lidocaine; 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection
Active Comparator: lidocaine subcutaneous injection alone 1% lidocaine subcutaneous injection alone by standard approach	Drug: lidocaine; 1% lidocaine subcutaneous injection alone

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Pain Assessment: Lidocaine Injection [post procedure (day 1)]

   visual analog scale (VAS) 0= no pain to 100 = worse pain possible

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Chicago Medical Center	Chicago	Illinois	United States	60637

Sponsors and Collaborators

• University of Chicago

Investigators

• Principal Investigator: John P Kress, MD., Univeristy of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT01330134
• Other Study ID Numbers: 10-621A
• First Posted: Apr 6, 2011
• Last Update Posted: Jul 26, 2018
• Last Verified: Jun 1, 2018

• Keywords provided by University of Chicago: procedural
• Additional relevant MeSH terms: Lidocaine

Study Results

Participant Flow

Arm/Group Title	Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection	Lidocaine Subcutaneous Injection Alone
Arm/Group Description	lidocaine: 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection.	lidocaine: 1% lidocaine subcutaneous injection alone.
Period Title: Overall Study
STARTED	244	237
COMPLETED	244	237
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection	Lidocaine Subcutaneous Injection Alone	Total
Arm/Group Description	lidocaine: 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection.	lidocaine: 1% lidocaine subcutaneous injection alone.	Total of all reporting groups
Overall Participants	244	237	481
Age (years) [Mean (Inter-Quartile Range) ]
Mean (Inter-Quartile Range) [years]	58.5	56.8	57.4
Sex: Female, Male (Count of Participants)
Female	120 49.2%	105 44.3%	225 46.8%
Male	124 50.8%	132 55.7%	256 53.2%
Race/Ethnicity, Customized (Count of Participants)
white, nonhispanic	136 55.7%	123 51.9%	259 53.8%
white, hispanic	10 4.1%	14 5.9%	24 5%
african american	90 36.9%	94 39.7%	184 38.3%
asian	5 2%	3 1.3%	8 1.7%
other	3 1.2%	3 1.3%	6 1.2%

Outcome Measures

1. Primary Outcome

Title	Pain Assessment: Overall
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection	Lidocaine Subcutaneous Injection Alone
Arm/Group Description	lidocaine: 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection.	lidocaine: 1% lidocaine subcutaneous injection alone.
Measure Participants	244	237
Mean (Standard Deviation) [units on a scale]	15.3 (19.3)	19.0 (22.8)

2. Secondary Outcome

Title	Pain Assessment: Lidocaine Injection
Description	visual analog scale (VAS) 0= no pain to 100 = worse pain possible
Time Frame	post procedure (day 1)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection	Lidocaine Subcutaneous Injection Alone
Arm/Group Description	lidocaine: 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection.	lidocaine: 1% lidocaine subcutaneous injection alone.
Measure Participants	244	237
Mean (Standard Deviation) [units on a scale]	18.4 (21.2)	20.8 (23.5)

3. Secondary Outcome

Title	Pain Assessment: During Procedure
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection	Lidocaine Subcutaneous Injection Alone
Arm/Group Description	lidocaine: 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection.	lidocaine: 1% lidocaine subcutaneous injection alone.
Measure Participants	244	237
Mean (Standard Deviation) [units on a scale]	12.2 (19.4)	16.6 (24.8)

Adverse Events

Arm/Group Title	Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection		Lidocaine Subcutaneous Injection Alone
Arm/Group Description	lidocaine: 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection		lidocaine: 1% lidocaine subcutaneous injection alone
All Cause Mortality
	Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection		Lidocaine Subcutaneous Injection Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/244 (0%)		0/237 (0%)
Serious Adverse Events
	Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection		Lidocaine Subcutaneous Injection Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/244 (0%)		0/237 (0%)
Other (Not Including Serious) Adverse Events
	Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection		Lidocaine Subcutaneous Injection Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/244 (0%)		0/237 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.