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

Not Applicable

Withdrawn

• Conditions: Pain
• Interventions: Other: Cold Compress Pack; Other: Room Temperature Compress Pack; Drug: Lidocaine Epinephrine

• Registration Number: NCT04991597
• Lead Sponsor: Nicholas Bastidas

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-03
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-05
• Study Start: 2022-01-01
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-18
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Left Forearm Injection Sites Cooled, Right Forearm Injection Sites at Room Temperature	Lidocaine Epinephrine	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.
Right Forearm Injection Sites Cooled, Left Forearm Injection Sites at Room Temperature	Cold Compress Pack	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.
Right Forearm Injection Sites Cooled, Left Forearm Injection Sites at Room Temperature	Room Temperature Compress Pack	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.
Right Forearm Injection Sites Cooled, Left Forearm Injection Sites at Room Temperature	Lidocaine Epinephrine	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.
Left Forearm Injection Sites Cooled, Right Forearm Injection Sites at Room Temperature	Cold Compress Pack	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.
Left Forearm Injection Sites Cooled, Right Forearm Injection Sites at Room Temperature	Room Temperature Compress Pack	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Injection Method Preference	2 Months	Participants will select which of the 4 injection methods they preferred