Comparison of Two Lidocaine Administration Techniques

Pain Clinical Trial

Official title:

Comparison of Two Lidocaine Administration Techniques

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01330134
• Other study ID #: 10-621A
• Status: Completed
• Phase: Phase 4
• Start date: February 2011
• Est. completion date: April 2015

Study information

• Verified date: June 2018
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 481
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
United States	The University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Assessment: Overall	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	Pain Assessment: Lidocaine Injection	visual analog scale (VAS) 0= no pain to 100 = worse pain possible	post procedure (day 1)
Secondary	Pain Assessment: During Procedure	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)