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

Phase 4

Completed

• Conditions: IV Insertion Pain
• Interventions: Drug: 1% lidocaine; Drug: bacteriostatic normal saline (BNS)

• Registration Number: NCT02162680
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2014-06
• Study First Submitted: 2014-06-11
• Study First Submitted QC: 2014-06-11
• Study First Posted: 2014-06-13
• Results First Submitted: 2014-06-26
• Results First Submitted QC: 2014-07-29
• Last Update Submitted: 2014-07-29
• Results First Posted: 2014-08-15
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lidocaine	1% lidocaine	1% lidocaine intradermal injection
bacteriostatic normal saline (BNS)	bacteriostatic normal saline (BNS)	bacteriostatic normal saline (BNS) injection

Primary Outcome Measures

Name	Time	Method
Differences in Patients' Perceptions of Pain Between Treatment Methods	at pre injection, during anesthetic injection, and during catheter insertion, up to approximately 1 minute	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.