Pain Perception: Lidocaine Rate/Temp/Buffer

Pain Clinical Trial

Official title:

The Impact of Anesthetic Injection Rate, Temperature and Buffering on Pain Perception During Dermatologic Procedures: a Multicenter, Single-blinded Randomized Control Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02823002
• Other study ID #: STU00202894
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2016
• Est. completion date: January 2025

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will collect data from multiple academic institutions. The primary objective for part A of this study is to determine the impact of anesthetic injection rate and temperature on pain perception during dermatologic procedures, and the objective for the part B of this study is to determine if buffering of the anesthetic solution alters pain perception.

This study is a pilot study designed to determine feasibility of these procedures.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Subjects who are undergoing dermatologic procedures.

• Subjects ages 18-89 year old.

• The subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator.

Exclusion Criteria:

• Subjects who are allergic to lidocaine.

• History of bleeding tendency or coagulopathy.

• Pregnant or lactating.

• Active skin disease or skin infection in the treatment area.

• Unable to understand the protocol or give informed consent.

• Any other condition, in the professional opinion of the investigator, that would potentially affect response or participation in the clinical study, or would pose as an unacceptable risk to the subject.

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• Slow, Room Temperature Injection
The room temperature local anesthetic agent will be administered by slow infiltration.
• Rapid, Room Temperature Injection
The room temperature local anesthetic agent will be administered by rapid infiltration.
• Slow, Warm Temperature Injection
The warmed local anesthetic agent will be administered by slow infiltration.
• Rapid, Warm Temperature Injection
The warmed local anesthetic agent will be administered by rapid infiltration.
• Buffered Injection
One side of the body will be randomized to receive an injection of the buffered agent, while the contralateral side will be assigned to receive an injection of the unbuffered anesthetic agent.
• Non-Buffered Injection
One side of the body will be randomized to receive an injection of the buffered agent, while the contralateral side will be assigned to receive an injection of the unbuffered anesthetic agent.

Drug:
• Lidocaine
Injectable lidocaine solution (Lidocaine Hydrochloride and Epinephrine)
• Buffer
Sodium Bicarbonate

Locations

Country	Name	City	State
United States	Northwestern University Department of Dermatology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain on a Visual Analog Scale (VAS)	Subjects will rate the pain VAS score immediately after the needle is withdrawn. They will be asked to rate the pain of the injection of the solution. VAS pain scale is rated on a 10 cm scale with 0 cm being no pain and 10 cm being extremely painful.	intraoperative