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

NCT ID: NCT02162680

Last Updated: 2014-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-07-31

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.

Conditions

IV Insertion Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

lidocaine

1% lidocaine intradermal injection

Group Type: ACTIVE_COMPARATOR

1% lidocaine

Intervention Type: DRUG

bacteriostatic normal saline (BNS)

bacteriostatic normal saline (BNS) injection

Group Type: ACTIVE_COMPARATOR

bacteriostatic normal saline (BNS)

Intervention Type: DRUG

no local anesthetic

usual care practice of no local anesthetic administration

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

1% lidocaine

Intervention Type: DRUG

bacteriostatic normal saline (BNS)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julia Aucoin, DNS, RN

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Other Identifiers

Pro00015861

Identifier Type: -

Identifier Source: org_study_id