Pain Perception: Lidocaine Rate/Temp/Buffer

NCT02823002 | Active Not Recruiting DMC

• 1 other identifier: STU00202894
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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  Subjects will rate the pain VAS score immediately after the needle is withdrawn.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

Study Arms (6)

Slow, Room Temperature

EXPERIMENTAL

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; Drug: Lidocaine; Drug: Buffer

Rapid, Room Temperature

EXPERIMENTAL

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; Drug: Lidocaine; Drug: Buffer

Slow, Warmed

EXPERIMENTAL

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; Drug: Lidocaine; Drug: Buffer

Rapid, Warmed

EXPERIMENTAL

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; Drug: Lidocaine; Drug: Buffer

Buffered

EXPERIMENTAL

In Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered.

Procedure: Buffered Injection; Drug: Lidocaine; Drug: Buffer

Non-Buffered

PLACEBO COMPARATOR

In Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered.

Procedure: Non-Buffered Injection; Drug: Lidocaine

Interventions

Slow, Room Temperature Injection PROCEDURE

The room temperature local anesthetic agent will be administered by slow infiltration.

Slow, Room Temperature

Rapid, Room Temperature Injection PROCEDURE

The room temperature local anesthetic agent will be administered by rapid infiltration.

Rapid, Room Temperature

Slow, Warm Temperature Injection PROCEDURE

The warmed local anesthetic agent will be administered by slow infiltration.

Slow, Warmed

Rapid, Warm Temperature Injection PROCEDURE

The warmed local anesthetic agent will be administered by rapid infiltration.

Rapid, Warmed

Buffered Injection PROCEDURE

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.

Buffered

Non-Buffered Injection PROCEDURE

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

Lidocaine DRUG

Injectable lidocaine solution (Lidocaine Hydrochloride and Epinephrine)

Buffered; Non-Buffered; Rapid, Room Temperature; Rapid, Warmed; Slow, Room Temperature; Slow, Warmed

Buffer DRUG

Sodium Bicarbonate

Buffered; Rapid, Room Temperature; Rapid, Warmed; Slow, Room Temperature; Slow, Warmed

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Ampholyte Mixtures; Lidocaine; Buffers

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Laboratory Chemicals; Specialty Uses of Chemicals; Chemical Actions and Uses; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: July 6, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

US (1)