An Evaluation of the Effectiveness of Local Anesthetics Used During Intravenous Catheter Insertion

Study Overview
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Brief Summary
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The purpose of this study is to compare how well different anesthetic, or numbing, solutions injected under the skin work in reducing the discomfort associated with placing a catheter in a vein. Two different medications, lidocaine and normal saline with benzyl alcohol, have been found to be effective in reducing discomfort when injected under the skin just prior to inserting the catheter. This study compares these two solutions, and will compare the discomfort that occurs both with and without using these solutions.

Official Title
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An Evaluation of the Effectiveness of Local Anesthetics Used During Intravenous Catheter Insertion

Conditions
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IV Insertion Pain

Intervention / Treatment
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* Drug: 1% lidocaine
* Drug: bacteriostatic normal saline (BNS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients (aged 18 or older) admitted to a general medical or surgical unit at Durham Regional Hospital (DRH) have a physician's order for an IV are able to speak, read and understand English referred to the Vascular Access Specialty Team (VAST) at DRH for IV catheterization Exclusion Criteria: admission to the emergency room, pre-op unit, an outpatient unit, a psychiatric unit, an intensive care unit, a pre- or postnatal care unit, or labor and delivery units; history of a psychological disorder, as determined from the patient's chart; history of peripheral neuropathy, as determined by patient's chart; history of IV drug abuse, as determined from the patient's chart; decreased sensation in the arm or hands, as reported in the chart or by the patient; patient disorientation or confusion (i.e., unable to state person, place, time or unable to comprehend instructions for completing Visual Analog Scale); a known allergy to lidocaine or benzyl alcohol as determined from the patient's chart; veins that cannot be palpated and are difficult to visualize by VAST nurses; pregnancy; an order for the emergency insertion of an IV by the patient's doctor or assigned nurse; an IV insertion that requires the use of a catheter gauged 18 or larger severe vision impairment, as determined by the patient's inability to read the Visual Analogue Scale

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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No

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lidocaine<br>1% lidocaine intradermal injection | Drug: 1% lidocaine<br> <br> |
| Active Comparator: bacteriostatic normal saline (BNS)<br>bacteriostatic normal saline (BNS) injection | Drug: bacteriostatic normal saline (BNS)<br> <br> |
| No Intervention: no local anesthetic<br>usual care practice of no local anesthetic administration | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in Patients' Perceptions of Pain Between Treatment Methods | The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. The visual analog pain score will be completed at the following time points: pre injection, during injection, and during catheter insertion. | at pre injection, during anesthetic injection, and during catheter insertion, up to approximately 1 minute | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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local anesthesia, intravenous catheter