Pain Perception: Lidocaine Rate/Temp/Buffer

March 14, 2024 updated by: Murad Alam, Northwestern University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Department of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Slow, Room Temperature
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.
Procedure: Slow, Room Temperature Injection
The room temperature local anesthetic agent will be administered by slow infiltration.
Drug: Lidocaine
Injectable lidocaine solution (Lidocaine Hydrochloride and Epinephrine)
Drug: Buffer
Sodium Bicarbonate
Experimental: Rapid, Room Temperature
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.
Drug: Lidocaine
Injectable lidocaine solution (Lidocaine Hydrochloride and Epinephrine)
Drug: Buffer
Sodium Bicarbonate
Procedure: Rapid, Room Temperature Injection
The room temperature local anesthetic agent will be administered by rapid infiltration.
Experimental: Slow, Warmed
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.
Drug: Lidocaine
Injectable lidocaine solution (Lidocaine Hydrochloride and Epinephrine)
Drug: Buffer
Sodium Bicarbonate
Procedure: Slow, Warm Temperature Injection
The warmed local anesthetic agent will be administered by slow infiltration.
Experimental: Rapid, Warmed
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.
Drug: Lidocaine
Injectable lidocaine solution (Lidocaine Hydrochloride and Epinephrine)
Drug: Buffer
Sodium Bicarbonate
Procedure: Rapid, Warm Temperature Injection
The warmed local anesthetic agent will be administered by rapid infiltration.
Experimental: Buffered
In Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered.
Drug: Lidocaine
Injectable lidocaine solution (Lidocaine Hydrochloride and Epinephrine)
Drug: Buffer
Sodium Bicarbonate
Procedure: 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.
Placebo Comparator: Non-Buffered
In Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered.
Drug: Lidocaine
Injectable lidocaine solution (Lidocaine Hydrochloride and Epinephrine)
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain on a Visual Analog Scale (VAS)
Time Frame: 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.
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Murad Alam, MD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

June 27, 2016

First Submitted That Met QC Criteria

June 30, 2016

First Posted (Estimated)

July 6, 2016

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00202894

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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