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

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.

Study Overview

• Status: Completed
• Conditions: IV Insertion Pain
• Intervention / Treatment: Drug: 1% lidocaine; Drug: bacteriostatic normal saline (BNS)

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: lidocaine; 1% lidocaine intradermal injection	Drug: 1% lidocaine
ACTIVE_COMPARATOR: bacteriostatic normal saline (BNS); bacteriostatic normal saline (BNS) injection	Drug: bacteriostatic normal saline (BNS)
NO_INTERVENTION: no local anesthetic; usual care practice of no local anesthetic administration

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Julia Aucoin, DNS, RN, Duke Health

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): July 1, 2011
• Study Completion (ACTUAL): July 1, 2011

Study Registration Dates

• First Submitted: June 11, 2014
• First Submitted That Met QC Criteria: June 11, 2014
• First Posted (ESTIMATE): June 13, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): August 15, 2014
• Last Update Submitted That Met QC Criteria: July 29, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: local anesthesia; intravenous catheter
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: Pro00015861