Comparison of Two Lidocaine Administration Techniques

The University of Chicago

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01330134

10-621A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 481 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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481 participants in 2 patient groups

lidocaine onto skin prior to lidocaine subcutaneous injection

Experimental group

Description:

1-2ml of 1% lidocaine dripped onto the surface of the skin immediately prior to subcutaneous injection of 1% lidocaine.

Treatment:

Drug: lidocaine

Drug: lidocaine

lidocaine subcutaneous injection alone

Active Comparator group

Description:

1% lidocaine subcutaneous injection alone by standard approach

Treatment:

Drug: lidocaine

Drug: lidocaine