The Effects of Injection Site Cooling and Solution Buffering on Perceived Pain During Local Anesthesia Administration

Participants will have local anesthesia administered to the palmar aspect of both forearms using 4 different injection methods in order to determine which method provides the best results in terms of perceived pain, overall comfort, and participant preference. Injection site cooling and solution buffering using a 3:1 ratio will be compared to the current standard, no injection site cooling and 9:1 solution buffering.

Study Overview

• Status: Withdrawn
• Conditions: Pain
• Intervention / Treatment: Other: Cold Compress Pack; Other: Room Temperature Compress Pack; Drug: Lidocaine Epinephrine; Drug: Lidocaine Epinephrine

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures
• Any gender, aged 21 - 65
• In good general health with no peripheral neuropathy or disorders that may produce peripheral neuropathy such as uncontrolled diabetes mellitus
• Healthy intact skin on the palmar aspect of both left and right forearms
• Fluent in English

Exclusion Criteria:

• Current use of any medication
• Pregnancy
• Known allergic reactions to components of the local anesthetic such as sulfites
• History of vasovagal response to venipuncture or vaccination
• History of trauma to the forearms i.e., bone breaks, burns, deep lacerations
• Decreased sensation to the palmar aspect of either forearm

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Left Forearm Injection Sites Cooled, Right Forearm Injection Sites at Room Temperature; Palmar aspect of participants left forearm will have a cold compress pack placed on it. The palmar aspect of the right forearm will have a room temperature compress pack placed on it. Each forearm will be injected with 1mL of lidocaine with epinephrine buffered with sodium bicarbonate. Each forearm will be injected once with the experimental ratio (3:1) and once with the standard control ratio (9:1). Injections will be administered in a randomized order.	Other: Cold Compress Pack; Palmar aspect of forearm will have a cold compress pack placed on it.; Other: Room Temperature Compress Pack; Palmar aspect of forearm will have a room temperature compress pack placed on it.; Drug: Lidocaine Epinephrine; Lidocaine with epinephrine will be buffered 3:1 with sodium bicarbonate; Other Names: Lidocaine Epinephrine buffered with Sodium Bicarbonate; Drug: Lidocaine Epinephrine; Lidocaine with epinephrine will be buffered 9:1 with sodium bicarbonate; Other Names: Lidocaine Epinephrine buffered with Sodium Bicarbonate
Experimental: Right Forearm Injection Sites Cooled, Left Forearm Injection Sites at Room Temperature; Palmar aspect of participants right forearm will have a cold compress pack placed on it. The palmar aspect of the left forearm will have a room temperature compress pack placed on it. Each forearm will be injected with 1mL of lidocaine with epinephrine buffered with sodium bicarbonate. Each forearm will be injected once with the experimental ratio (3:1) and once with the standard control ratio (9:1). Injections will be administered in a randomized order.	Other: Cold Compress Pack; Palmar aspect of forearm will have a cold compress pack placed on it.; Other: Room Temperature Compress Pack; Palmar aspect of forearm will have a room temperature compress pack placed on it.; Drug: Lidocaine Epinephrine; Lidocaine with epinephrine will be buffered 3:1 with sodium bicarbonate; Other Names: Lidocaine Epinephrine buffered with Sodium Bicarbonate; Drug: Lidocaine Epinephrine; Lidocaine with epinephrine will be buffered 9:1 with sodium bicarbonate; Other Names: Lidocaine Epinephrine buffered with Sodium Bicarbonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain from Needle Insertion	Pain from needle insertion during each injection will be scored on a 0 - 10 scale by participants	2 Months
Pain from Solution Deposition	Pain from solution deposition during each injection will be scored on a 0 - 10 scale by participants	2 Months
Overall Comfort Level During Injection	Comfort level during each injection will be scored on a 0 - 10 scale by participants	2 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Injection Method Preference	Participants will select which of the 4 injection methods they preferred	2 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Buffered Anesthetic Solution pH	pH of each solution will be measured using a calibrated pH probe	2 Months

Collaborators and Investigators

• Sponsor: Nicholas Bastidas
• Investigators: Principal Investigator: Nicholas Bastidas, MD, Northwell Health

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): May 31, 2022
• Study Completion (Anticipated): May 31, 2022

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 18, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Pain; Lidocaine; Local Anesthesia; Bicarbonate; Buffering; Injection Site Cooling
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: LESB 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes