- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02162680
An Evaluation of the Effectiveness of Local Anesthetics Used During Intravenous Catheter Insertion
July 29, 2014 updated by: Duke University
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
99
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: lidocaine
1% lidocaine intradermal injection
|
|
ACTIVE_COMPARATOR: bacteriostatic normal saline (BNS)
bacteriostatic normal saline (BNS) injection
|
|
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
Time Frame: 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.
|
at pre injection, during anesthetic injection, and during catheter insertion, up to approximately 1 minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Julia Aucoin, DNS, RN, Duke Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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