Comparison of Two Lidocaine Administration Techniques

June 27, 2018 updated by: University of Chicago

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

481

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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
Drug: lidocaine
1% lidocaine subcutaneous injection alone
ACTIVE_COMPARATOR: lidocaine subcutaneous injection alone
1% lidocaine subcutaneous injection alone by standard approach
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
post procedure (day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Assessment: Lidocaine Injection
Time Frame: post procedure (day 1)
visual analog scale (VAS) 0= no pain to 100 = worse pain possible
post procedure (day 1)
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.
post procedure (day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: John P Kress, MD., Univeristy of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

April 4, 2011

First Submitted That Met QC Criteria

April 5, 2011

First Posted (ESTIMATE)

April 6, 2011

Study Record Updates

Last Update Posted (ACTUAL)

July 26, 2018

Last Update Submitted That Met QC Criteria

June 27, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-621A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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