Pain Perception: Lidocaine Rate/Temp/Buffer

Sponsor

Northwestern University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02823002

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Procedure: Slow, Room Temperature Injection Procedure: Rapid, Room Temperature Injection Procedure: Slow, Warm Temperature Injection Procedure: Rapid, Warm Temperature Injection Procedure: Buffered Injection Procedure: Non-Buffered Injection Drug: Lidocaine Drug: Buffer	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jun 1, 2016

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Department of Dermatology	Chicago	Illinois	United States	60611

Sponsors and Collaborators

Northwestern University

Investigators

Principal Investigator: Murad Alam, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Murad Alam, Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery, Northwestern University

ClinicalTrials.gov Identifier:

NCT02823002

Other Study ID Numbers:

STU00202894

First Posted:

Jul 6, 2016

Last Update Posted:

Mar 4, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Lidocaine

Study Results

No Results Posted as of Mar 4, 2022