Comparison of Two Lidocaine Administration Techniques
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University of Chicago
- Enrollment
- 481
- Locations
- 1
- Primary Endpoint
- Pain Assessment: Overall
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: lidocaine (Drug)
lidocaine subcutaneous injection alone
1% lidocaine subcutaneous injection alone by standard approach
Intervention: lidocaine (Drug)
Outcomes
Primary Outcomes
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
- Pain Assessment: Lidocaine Injection(post procedure (day 1))
- Pain Assessment: During Procedure(post procedure (day 1))