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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition IV Insertion Pain
Interventions Drug: 1% lidocaine
Drug: bacteriostatic normal saline (BNS)
Enrollment 99
Recruitment Details 99 subjects consented in the study. 1 subject withdrawn from study by PI, therefore 98 subjects completed study.
Pre-assignment Details  
Arm/Group Title no Local Anesthetic Lidocaine Bacteriostatic Normal Saline (BNS)
Hide Arm/Group Description usual care practice of no local anesthetic administration

1% lidocaine intradermal injection

1% lidocaine

bacteriostatic normal saline (BNS) injection

bacteriostatic normal saline (BNS)

Period Title: Overall Study
Started 33 33 32
Completed 33 33 32
Not Completed 0 0 0
Arm/Group Title no Local Anesthetic Lidocaine Bacteriostatic Normal Saline (BNS) Total
Hide Arm/Group Description usual care practice of no local anesthetic administration

1% lidocaine intradermal injection

1% lidocaine

bacteriostatic normal saline (BNS) injection

bacteriostatic normal saline (BNS)

Total of all reporting groups
Overall Number of Baseline Participants 33 33 32 98
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
18 and older Number Analyzed 33 participants 33 participants 32 participants 98 participants
33 33 32 98
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 32 participants 98 participants
Female
16
  48.5%
23
  69.7%
16
  50.0%
55
  56.1%
Male
17
  51.5%
10
  30.3%
16
  50.0%
43
  43.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 32 participants 98 participants
White 23 21 15 59
African American 8 7 15 30
Other 2 5 2 9
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants 33 participants 32 participants 98 participants
33 33 32 98
1.Primary Outcome
Title Differences in Patients' Perceptions of Pain Between Treatment Methods
Hide Description 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.
Time Frame at pre injection, during anesthetic injection, and during catheter insertion, up to approximately 1 minute
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title no Local Anesthetic Lidocaine Bacteriostatic Normal Saline (BNS)
Hide Arm/Group Description:
usual care practice of no local anesthetic administration

1% lidocaine intradermal injection

1% lidocaine

bacteriostatic normal saline (BNS) injection

bacteriostatic normal saline (BNS)

Overall Number of Participants Analyzed 33 33 32
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pain pre injection 0.015  (0.87) 0  (0) 0  (0)
Pain during catheter insertion 1.909  (2.127) 0.197  (0.499) 0.609  (1.674)
Pain during study drug injection NA [1]   (NA) 0.727  (1.039) 0.781  (1.263)
[1]
Participants did not receive a study drug injection.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title no Local Anesthetic Lidocaine Bacteriostatic Normal Saline (BNS)
Hide Arm/Group Description usual care practice of no local anesthetic administration

1% lidocaine intradermal injection

1% lidocaine

bacteriostatic normal saline (BNS) injection

bacteriostatic normal saline (BNS)

All-Cause Mortality
no Local Anesthetic Lidocaine Bacteriostatic Normal Saline (BNS)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
no Local Anesthetic Lidocaine Bacteriostatic Normal Saline (BNS)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%)   0/32 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
no Local Anesthetic Lidocaine Bacteriostatic Normal Saline (BNS)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%)   0/32 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Julia Aucoin, DNS
Organization: Duke University Medical Center
Phone: 1 919 613 6406
EMail: julia.aucoin@dm.duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02162680    
Other Study ID Numbers: Pro00015861
First Submitted: June 11, 2014
First Posted: June 13, 2014
Results First Submitted: June 26, 2014
Results First Posted: August 15, 2014
Last Update Posted: August 15, 2014