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Comparison of Two Techniques of IV Lidocaine on Propofol Injection Pain

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: NCT03057704
Recruitment Status : Completed
First Posted : February 20, 2017
Results First Posted : February 13, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
Intravenous lidocaine is commonly given through an intravenous (IV) line prior to injection of propofol to reduce the amount of pain during propofol injection. The investigators want to study if giving the lidocaine through the IV while the forearm on the same limb has a tourniquet applied to it to prevent "washing out" of the lidocaine prior to propofol injection helps reduce propofol injection pain.

Condition or disease Intervention/treatment Phase
Injections, Intravenous Drug: Lidocaine injection flushed Drug: Lidocaine injection tourniquet Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, controlled trial of two methods of administering lidocaine prior to propofol injection
Masking: Single (Participant)
Masking Description: The participant is not told which group they are randomized to. However, a tourniquet is applied in the experimental group, thus some subjects may reason that they are in the experimental group. The study coordinator is aware which group the subject is in.
Primary Purpose: Treatment
Official Title: Comparison of Two Techniques of Administering IV Lidocaine in Reducing Propofol Injection Pain
Actual Study Start Date : December 5, 2016
Actual Primary Completion Date : January 20, 2017
Actual Study Completion Date : January 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intravenous lidocaine: flushed
Lidocaine injection flushed
Drug: Lidocaine injection flushed
The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol.
Other Name: Xylocaine

Experimental: Intravenous lidocaine: tourniquet
Lidocaine injection tourniquet
Drug: Lidocaine injection tourniquet
Intravenous lidocaine: tourniquet
Other Names:
  • Xylocaine
  • Tourniquet




Primary Outcome Measures :
  1. Patient Expression of Pain [ Time Frame: During injection at beginning of study; lasts 10 seconds one time only ]

    Patient's verbal rating of pain during injection (see link to study protocol)

    We used a Verbal Rating Scale from the patient that self-described discomfort level during injection using question:

    How would you rate your pain using None, Mild, Moderate, Severe and record it on this 4-point scale:

    • None (0)
    • Mild (1)
    • Moderate (2)
    • Severe (3) None is no pain (best outcome) and Severe is worst pain possible (worst outcome).


Secondary Outcome Measures :
  1. Subject's Recall of Injection Discomfort [ Time Frame: This occurs 30 minutes after the subject's procedure is finished in the recovery room; lasts 30 seconds one time only ]

    Investigator asks patient if they recall discomfort during injection after the procedure.

    Patient's verbal rating and recall of pain during injection.

    We used a Verbal Rating Scale from the patient that self-described discomfort level during injection using question:

    How would you rate your pain using None, Mild, Moderate, Severe and record it on this 4-point scale:

    • None (0)
    • Mild (1)
    • Moderate (2)
    • Severe (3) None is no pain (best outcome) and Severe is worst pain possible (worst outcome).

  2. Investigators Rating of Patient Discomfort [ Time Frame: During injection at beginning of study period; lasts 10 seconds one time only ]

    Investigator rates patient's nonverbal display of discomfort.

    Investigator Assessments:

    Induction Discomfort Scale (during injection and within 5 seconds after injection)

    • No change in patient behavior (0)
    • Grimace (1)
    • IV forearm withdrawal (2)
    • Moaning (3)
    • Verbal statement of discomfort ("it hurts", etc.) (4) 0 indicates desired outcome of no pain and 4 indicates worst IV pain experienced.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any subject at North Carolina Baptist Hospital scheduled for a procedure in which they will receive propofol for sedation or anesthesia and will not be receiving any other medications prior to the propofol injection.
  • Cases must be schedule to have a duration less than 60 minutes.

Exclusion Criteria:

  • Subjects are excluded if they cannot verbalize a rating of pain
  • Subjects are excluded if they require intravenous medications prior to the study period

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): NCT03057704


Locations
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United States, North Carolina
North Carolina Baptist Hospital
Winston-Salem, North Carolina, United States, 27612
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Timothy N Harwood, MD Wake Forest University Health Sciences
Study Director: Patrick Grace, MD Wake Forest University Health Sciences
  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03057704    
Other Study ID Numbers: IRB00040756
First Posted: February 20, 2017    Key Record Dates
Results First Posted: February 13, 2018
Last Update Posted: September 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Wake Forest University Health Sciences:
Propofol
lidocaine
pain
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