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Comparison of Two Lidocaine Administration Techniques

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ClinicalTrials.gov Identifier: NCT01330134
Recruitment Status : Completed
First Posted : April 6, 2011
Results First Posted : June 28, 2018
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Description
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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 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
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Study Type : Interventional  (Clinical Trial)
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 : February 2011
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Pain Assessment: Overall [ Time Frame: 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 [ Time Frame: post procedure (day 1) ]
    visual analog scale (VAS) 0= no pain to 100 = worse pain possible

  2. Pain Assessment: During Procedure [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01330134


Locations
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United States, Illinois
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: John P Kress, MD. Univeristy of Chicago
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01330134    
Other Study ID Numbers: 10-621A
First Posted: April 6, 2011    Key Record Dates
Results First Posted: June 28, 2018
Last Update Posted: July 26, 2018
Last Verified: June 2018
Keywords provided by University of Chicago:
procedural
Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
 Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action