Local Anesthetics for Pain Reduction Prior to IV Line Placement

Study Overview
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Brief Summary
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The purpose of this study is to compare the pain level felt by patients when receiving placement of a peripheral intravenous catheter (IV line) following the administration of a local anesthetic. The local anesthetics tested will be lidocaine, buffered lidocaine, and bacteriostatic normal saline. Lidocaine is commonly used as a premedication for reducing the pain upon insertion of peripheral IV lines. However, due to its acidic nature, the lidocaine itself may cause pain upon administration. To help counter this discomfort, pharmacies can buffer the lidocaine using sodium bicarbonate, which increases the pH to a neutral value, resulting in less pain. Bacteriostatic normal saline has also been used for local anesthesia with peripheral IV placement, particularly in patients with a lidocaine allergy, as it contains benzyl alcohol which acts as a local anesthetic. There are minimal reports from the literature that directly compare patient reported pain of all three agents to one another, although studies do exist that have compared buffered lidocaine versus lidocaine and buffered lidocaine versus bacteriostatic normal saline. To address this comparison gap, the following research questions need to be asked: which anesthetic agent is the superior premedication for reducing the amount of pain upon administration of the local anesthetic itself and for the pain associated with the peripheral insertion of the catheter? The hypothesis of the investigators is that there is not a significant difference in the degree of pain scales between the anesthetic agents to justify the pharmacoeconomic costs associated with compounding buffered lidocaine. The primary outcome measured in this study will be the level of pain reported by the patient upon administration of the local anesthetic and upon insertion of the peripheral intravenous catheter. A secondary outcome includes a pharmacoeconomic analysis that will look specifically at the cost-savings of using one agent over the other and will take into account the daily time allocated to pharmacy technicians and pharmacists for compounding and verifying buffered lidocaine.

Official Title
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A Comparison of Lidocaine, Buffered Lidocaine, and Bacteriostatic Normal Saline for Local Anesthesia Prior to Peripheral Intravenous Catheterization

Conditions
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Pain, Local Anesthesia for Peripheral Intravenous Catheterization

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Buffered Lidocaine
* Drug: Bacteriostatic Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females > 18 y.o. Ability to speak, read, an/or understand English Ability to communicate a level of pain via the specified pain scale A written order exists for an intravenous peripheral catheter insertion for the patient Exclusion Criteria: Lidocaine allergy Buffered lidocaine allergy Benzyl alcohol allergy Non-English speaking Non-responsive or unable to understand or report pain score (ex. intubated in the ICU) Inability to place catheter

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine<br>1% Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm | Drug: Lidocaine<br>* The medication will be administered immediately prior to receiving peripheral IV catheter placement<br>* Other names: Hospira brand 1% Lidocaine in 20 mL vial;|
| Experimental: Buffered Lidocaine<br>1% Buffered Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm Buffered lidocaine is compounded by the following process: 2.3 mLs of 8.4% sodium bicarbonate is added to a vial of 1% lidocaine | Drug: Buffered Lidocaine<br>* The medication will be administered immediately prior to receiving peripheral IV catheter placement<br>* Other names: Hospira brand 8.4% sodium bicarbonate in 50 mL vial;|
| Experimental: Bacteriostatic Normal Saline<br>Bacteriostatic Normal Saline for injection, 0.50 mL administered one time intradermally in peripheral forearm | Drug: Bacteriostatic Normal Saline<br>* The medication will be administered immediately prior to receiving peripheral IV catheter placement<br>* Other names: Hospira brand Bacteriostatic Normal Saline in 10 mL vial;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score Following Anesthetic Administration | The primary outcome measured in this study will be the level of pain reported, on a scale of 0 to 10, 0 being no pain at all and 10 being the worst pain ever felt, by the patient upon administration of the local anesthetic and upon insertion of the peripheral intravenous catheter. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Economic Analysis of Cost of Compounding Buffered Lidocaine Versus Cost of Purchasing Regular Lidocaine and/or Bacteriostatic Normal Saline | A secondary outcome includes a pharmacoeconomic analysis that will look specifically at the cost-savings of using one agent over the other and will take into account the daily time allocated to pharmacy technicians and pharmacists for compounding and verifying buffered lidocaine. The outcome data was measured and reported in a single value dollar amount per group, tallied over a 3 month period. The dollar amounts were estimated by adding up the costs of drug purchasing, technician compounding time, and pharmacist verifying time. Buffered lidocaine required both drug purchasing and compounding time, where the lidocaine and bacteriostatic normal saline required drug purchasing alone and labor costs were not taken into account. | 3 months |