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Comparison of Two Lidocaine Administration Techniques

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01330134
First Posted: April 6, 2011
Last Update Posted: June 24, 2016
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.
Information provided by (Responsible Party):
University of Chicago
  Purpose

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 Intervention Phase
Pain Drug: lidocaine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Two Lidocaine Administration Techniques

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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:
  • Pain Assessment: lidocaine injection [ Time Frame: post procedure (day 1) ]
    VAS, WBFS, SF-MPQ

  • Pain assessment: during procedure [ Time Frame: post procedure (day 1) ]
    VAS, WBFS, SF-MPQ


Enrollment: 490
Study Start Date: February 2011
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
United States, Illinois
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
  More Information

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01330134     History of Changes
Other Study ID Numbers: 10-621A
First Submitted: April 4, 2011
First Posted: April 6, 2011
Last Update Posted: June 24, 2016
Last Verified: June 2016

Keywords provided by University of Chicago:
procedural

Additional relevant MeSH terms:
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


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