Comparison of Two Lidocaine Administration Techniques

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01330134
Recruitment Status : Completed
First Posted : April 6, 2011
Last Update Posted : June 24, 2016
Information provided by (Responsible Party):
University of Chicago

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 490 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

Arm Intervention/treatment
Experimental: lidocaine onto skin prior to lidocaine subcutaneous injection Drug: lidocaine
2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection

Active Comparator: lidocaine subcutaneous injection alone Drug: lidocaine
1% lidocaine subcutaneous injection alone

Primary Outcome Measures :
  1. Pain assessment: overall [ Time Frame: post procedure (day 1) ]
    Visual analog scale (VAS), Revised Faces Pain Scale (RFPS), short form mcGill pain questionnaire (SF-MPQ)

Secondary Outcome Measures :
  1. Pain Assessment: lidocaine injection [ Time Frame: post procedure (day 1) ]

  2. Pain assessment: during procedure [ Time Frame: post procedure (day 1) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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 identifier (NCT number): NCT01330134

United States, Illinois
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Principal Investigator: John P Kress, MD. Univeristy of Chicago

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Chicago Identifier: NCT01330134     History of Changes
Other Study ID Numbers: 10-621A
First Posted: April 6, 2011    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: June 2016

Keywords provided by University of Chicago:

Additional relevant MeSH terms:
Anesthetics, Local
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