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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162680
Recruitment Status : Completed
First Posted : June 13, 2014
Results First Posted : August 15, 2014
Last Update Posted : August 15, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
IV Insertion Pain Drug: 1% lidocaine Drug: bacteriostatic normal saline (BNS) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Evaluation of the Effectiveness of Local Anesthetics Used During Intravenous Catheter Insertion
Study Start Date : March 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162680


Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Julia Aucoin, DNS, RN Duke University Health System
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02162680    
Other Study ID Numbers: Pro00015861
First Posted: June 13, 2014    Key Record Dates
Results First Posted: August 15, 2014
Last Update Posted: August 15, 2014
Last Verified: June 2014
Keywords provided by Duke University:
local anesthesia
intravenous catheter
Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action