Comparison of Two Lidocaine Administration Techniques

NCT01330134 | Completed Phase 4 Results

• 1 other identifier: 10-621A
• Study Type: interventional
• Target: 481
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

procedural

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain Assessment: Lidocaine Injection

  post procedure (day 1)

• Pain Assessment: During Procedure

  post procedure (day 1)

Study Arms (2)

lidocaine onto skin prior to lidocaine subcutaneous injection

EXPERIMENTAL

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

Drug: lidocaine

lidocaine subcutaneous injection alone

ACTIVE COMPARATOR

1% lidocaine subcutaneous injection alone by standard approach

Drug: lidocaine

Interventions

lidocaine DRUG

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

lidocaine onto skin prior to lidocaine subcutaneous injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients refered to the University of Chicago Medical Centers Procedure Service for a planned medical procedure requiring local injection of lidocaine.

You may not qualify if:

• Patient who lack decisional capacity to consent
• Patients who lack the ability to answer questions in english using pain scales

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

• Patel BK, Wendlandt BN, Wolfe KS, Patel SB, Doman ER, Pohlman AS, Hall JB, Kress JP. Comparison of Two Lidocaine Administration Techniques on Perceived Pain From Bedside Procedures: A Randomized Clinical Trial. Chest. 2018 Oct;154(4):773-780. doi: 10.1016/j.chest.2018.04.018. Epub 2018 Apr 24.

  PMID: 29698720 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: John P. Kress, MD
• Organization: University of Chicago

jkress@medicine.bsd.uchicago.edu

773-702-1000

Study Officials

• John P Kress, MD.

  Univeristy of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: April 6, 2011
• Study Start: February 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: July 26, 2018
• Results First Posted: June 28, 2018

Record last verified: 2018-06

Locations

US (1)