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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Other: Cold Compress Pack
* Other: Room Temperature Compress Pack
* Drug: Lidocaine Epinephrine
* Drug: Lidocaine Epinephrine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Left Forearm Injection Sites Cooled, Right Forearm Injection Sites at Room Temperature<br>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<br>* Palmar aspect of forearm will have a cold compress pack placed on it.<br>Other: Room Temperature Compress Pack<br>* Palmar aspect of forearm will have a room temperature compress pack placed on it.<br>Drug: Lidocaine Epinephrine<br>* Lidocaine with epinephrine will be buffered 3:1 with sodium bicarbonate<br>* Other names: Lidocaine Epinephrine buffered with Sodium Bicarbonate;Drug: Lidocaine Epinephrine<br>* Lidocaine with epinephrine will be buffered 9:1 with sodium bicarbonate<br>* Other names: Lidocaine Epinephrine buffered with Sodium Bicarbonate;|
| Experimental: Right Forearm Injection Sites Cooled, Left Forearm Injection Sites at Room Temperature<br>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<br>* Palmar aspect of forearm will have a cold compress pack placed on it.<br>Other: Room Temperature Compress Pack<br>* Palmar aspect of forearm will have a room temperature compress pack placed on it.<br>Drug: Lidocaine Epinephrine<br>* Lidocaine with epinephrine will be buffered 3:1 with sodium bicarbonate<br>* Other names: Lidocaine Epinephrine buffered with Sodium Bicarbonate;Drug: Lidocaine Epinephrine<br>* Lidocaine with epinephrine will be buffered 9:1 with sodium bicarbonate<br>* Other names: Lidocaine Epinephrine buffered with Sodium Bicarbonate;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Local Anesthesia, Lidocaine, Bicarbonate, Pain, Buffering, Injection Site Cooling