Comparison of Two Lidocaine Administration Techniques

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: lidocaine

• Registration Number: NCT01330134
• Lead Sponsor: University of Chicago

Brief Summary

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.

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 Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-04-04
• Study First Submitted QC: 2011-04-05
• Study First Posted: 2011-04-06
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Results First Submitted: 2017-09-11
• Results First Submitted QC: 2018-05-30
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-27
• Results First Posted: 2018-06-28
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 481

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lidocaine onto skin prior to lidocaine subcutaneous injection	lidocaine	1-2ml of 1% lidocaine dripped onto the surface of the skin immediately prior to subcutaneous injection of 1% lidocaine.
lidocaine subcutaneous injection alone	lidocaine	1% lidocaine subcutaneous injection alone by standard approach

Primary Outcome Measures

Name	Time	Method
Pain Assessment: Overall	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 Outcome Measures

Name	Time	Method
Pain Assessment: Lidocaine Injection	post procedure (day 1)	visual analog scale (VAS) 0= no pain to 100 = worse pain possible
Pain Assessment: During Procedure	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.

Trial Locations

Locations (1)

The University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States