Pain Perception: Lidocaine Rate/Temp/Buffer

Not Applicable

Active, not recruiting

• Conditions: Pain
• Interventions: Procedure: Buffered Injection; Procedure: Rapid, Room Temperature Injection; Procedure: Non-Buffered Injection; Procedure: Slow, Room Temperature Injection; Procedure: Slow, Warm Temperature Injection; Procedure: Rapid, Warm Temperature Injection; Drug: Lidocaine; Drug: Buffer

• Registration Number: NCT02823002
• Lead Sponsor: Northwestern University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-06-30
• Study First Posted: 2016-07-06
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-15
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buffered	Buffered Injection	In Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered.
Slow, Room Temperature	Buffer	In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.
Rapid, Room Temperature	Rapid, Room Temperature Injection	In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.
Rapid, Room Temperature	Buffer	In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.
Slow, Warmed	Buffer	In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.
Non-Buffered	Non-Buffered Injection	In Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered.
Buffered	Buffer	In Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered.
Rapid, Warmed	Buffer	In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.
Slow, Room Temperature	Slow, Room Temperature Injection	In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.
Slow, Warmed	Slow, Warm Temperature Injection	In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.
Rapid, Warmed	Rapid, Warm Temperature Injection	In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.
Rapid, Room Temperature	Lidocaine	In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.
Slow, Room Temperature	Lidocaine	In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.
Slow, Warmed	Lidocaine	In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.
Rapid, Warmed	Lidocaine	In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.
Buffered	Lidocaine	In Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered.
Non-Buffered	Lidocaine	In Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered.

Primary Outcome Measures

Name	Time	Method
Pain on a Visual Analog Scale (VAS)	intraoperative	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.

Trial Locations

Locations (1)

Northwestern University Department of Dermatology; 🇺🇸 Chicago, Illinois, United States