Comparison of Two Lidocaine Administration Techniques

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01330134
First received: April 4, 2011
Last updated: March 12, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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) ] [ Designated as safety issue: No ]
    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) ] [ 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


Estimated Enrollment: 490
Study Start Date: February 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330134

Contacts
Contact: John P Kress, MD 773-7026404 jkress@medicine.bsd.uchicago.edu
Contact: Anne S Pohlman, MSN 773-702-3804 apohlman@medicine.bsd.uchicago.edu

Locations
United States, Illinois
The University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Principal Investigator: John P Kress, MD         
Sponsors and Collaborators
University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01330134     History of Changes
Other Study ID Numbers: 10-621A
Study First Received: April 4, 2011
Last Updated: March 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
procedural

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 23, 2014