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

NCT04991597 | Withdrawn

• 1 other identifier: LESB 001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Keywords

Local Anesthesia; Lidocaine; Bicarbonate; Pain; Buffering; Injection Site Cooling

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Injection Method Preference

  2 Months

Other Outcomes (1)

• Buffered Anesthetic Solution pH

  2 Months

Study Arms (2)

Left Forearm Injection Sites Cooled, Right Forearm Injection Sites at Room Temperature

EXPERIMENTAL

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; Other: Room Temperature Compress Pack; Drug: Lidocaine Epinephrine

Right Forearm Injection Sites Cooled, Left Forearm Injection Sites at Room Temperature

EXPERIMENTAL

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; Other: Room Temperature Compress Pack; Drug: Lidocaine Epinephrine

Interventions

Cold Compress Pack OTHER

Palmar aspect of forearm will have a cold compress pack placed on it.

Left Forearm Injection Sites Cooled, Right Forearm Injection Sites at Room Temperature; Right Forearm Injection Sites Cooled, Left Forearm Injection Sites at Room Temperature

Room Temperature Compress Pack OTHER

Palmar aspect of forearm will have a room temperature compress pack placed on it.

Left Forearm Injection Sites Cooled, Right Forearm Injection Sites at Room Temperature; Right Forearm Injection Sites Cooled, Left Forearm Injection Sites at Room Temperature

Lidocaine Epinephrine DRUG

Lidocaine with epinephrine will be buffered 3:1 with sodium bicarbonate

Also known as: Lidocaine Epinephrine buffered with Sodium Bicarbonate

Left Forearm Injection Sites Cooled, Right Forearm Injection Sites at Room Temperature; Right Forearm Injection Sites Cooled, Left Forearm Injection Sites at Room Temperature

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nicholas Bastidas: lead

MeSH Terms

Conditions

Pain

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Officials

• Nicholas Bastidas, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blind to the solution ratio of each injection, injector will not be blind to solution to ensure safety.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Plastic Surgery

Model Details: Palmar aspect of participants forearms will be randomized to have either a cold compress pack or a room temperature compress pack placed on it. The cold compress pack serves as the trial intervention and the room temperature compress pack serves as the placebo. Each forearm will then be injected with both a 3:1 (experimental ratio) and a 9:1 (standard ratio) mixture of lidocaine with epinephrine:sodium bicarbonate in a randomized order.

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 5, 2021
• Study Start: January 1, 2022
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share