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Completed

NCT Number: NCT01330134

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection

Primary outcomes

  1. 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.

Secondary outcomes

  1. Pain Assessment: Lidocaine Injection

    Time frame: post procedure (day 1)

    visual analog scale (VAS) 0= no pain to 100 = worse pain possible

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Apr 6, 2011
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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