Comparison of Two Lidocaine Administration Techniques

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01330134
First received: April 4, 2011
Last updated: June 22, 2016
Last verified: June 2016

April 4, 2011
June 22, 2016
February 2011
April 2015   (final data collection date for primary outcome measure)
Pain assessment: overall [ Time Frame: post procedure (day 1) ] [ Designated as safety issue: No ]
Visual analog scale (VAS), Revised Faces Pain Scale (RFPS), short form mcGill pain questionnaire (SF-MPQ)
Same as current
Complete list of historical versions of study NCT01330134 on ClinicalTrials.gov Archive Site
  • Pain Assessment: lidocaine injection [ Time Frame: post procedure (day 1) ] [ Designated as safety issue: No ]
    VAS, WBFS, SF-MPQ
  • Pain assessment: during procedure [ Time Frame: post procedure (day 1) ] [ Designated as safety issue: No ]
    VAS, WBFS, SF-MPQ
Same as current
Not Provided
Not Provided
 
Comparison of Two Lidocaine Administration Techniques
Comparison of Two Lidocaine Administration Techniques

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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Pain
  • Drug: lidocaine
    2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection
  • Drug: lidocaine
    1% lidocaine subcutaneous injection alone
  • Experimental: lidocaine onto skin prior to lidocaine subcutaneous injection
    Intervention: Drug: lidocaine
  • Active Comparator: lidocaine subcutaneous injection alone
    Intervention: Drug: lidocaine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
490
April 2015
April 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01330134
10-621A
No
Not Provided
Not Provided
University of Chicago
University of Chicago
Not Provided
Principal Investigator: John P Kress, MD. Univeristy of Chicago
University of Chicago
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP