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Vapocoolant Spray for Reducing the Pain of Spinal Needle Insertion

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
vapocoolant spray
local infiltration
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with low back pain and radiating pain in the lower limb who underwent a scheduled caudal epidural injection

Exclusion Criteria:

  • those who had systemic inflammatory disease, those who take anticoagulant administration, those who had uncontrolled diabetes, those who were unable to understand a visual analog scale (VAS) or a Likert scale, those with a history of cold intolerance or cold allergy, those with a history of allergic reaction to lidocaine, those who took pain medications or had used topical anesthetics within the previous 24 hrs, those who had a skin lesion on the sacral hiatus, and those who had the experience of caudal epidural injection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Vapocoolant spray group

    Local infiltration group

    Arm Description

    vapocoolant spray was applied for 10 second

    3 ml of 2% lidocaine infiltrated subcutaneously

    Outcomes

    Primary Outcome Measures

    100mm visual analog scale
    Pain of spinal needle insertion during caudal epidural injection

    Secondary Outcome Measures

    Five point Likert scale
    five-point Likert scale (1, strongly agree; 2, agree; 3, undecided; 4, disagree; and 5, strongly disagree) was used to answer two questions: ''Are you satisfied with the topical pre-CEI anesthesia used before the spinal needle insertion of CEI?'' and ''Will you use the topical pre-CEI anesthesia applied today again if CEI repeated in the future?''

    Full Information

    First Posted
    May 30, 2017
    Last Updated
    June 11, 2017
    Sponsor
    The Catholic University of Korea
    Collaborators
    Soonchunhyang University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03175913
    Brief Title
    Vapocoolant Spray for Reducing the Pain of Spinal Needle Insertion
    Official Title
    Ocoolant Spray vs Lidocaine Infiltration for Reducing the Pain of Spinal Needle Insertion During the Caudal Epidural Injection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2014 (Actual)
    Primary Completion Date
    December 1, 2015 (Actual)
    Study Completion Date
    December 1, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Catholic University of Korea
    Collaborators
    Soonchunhyang University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This was a single-blind, randomized controlled trial. Sixty-six patients who underwent caudal epidural injection were randomized into the vapocoolant spray group or local infiltration group. Before the insertion of a 20-gauge spinal needle, the subcutaneous tissue was infiltrated with 3 ml of 2% lidocaine in the local infiltration group and vapocoolant spray was applied just before the spinal needle insertion in the spray group. 100-mm visual analog scale to evaluate the pain intensity of spinal needle insertion and a five-point Likert scale for patient satisfaction and preference for repeated use were compared between the two groups.
    Detailed Description
    Interventions The intervention room was divided into two sections (intervention section and waiting section) using a blinded partition, for prompt coming and going by the investigators. Before the CEI, patient was informed about how to use a VAS and a five-point Likert scale. Then, patient anxiety about CEI was measured using the Likert scale with the following statement: "I am anxious about undergoing a CEI". After that, the patient was positioned on the table in a prone posture, and the interventionist, who was blinded to the other study procedures, palpated the sacral hiatus and marked with an indelible pen. Then he went behind the partition. Thereafter, the principal investigator entered the intervention section, opened and checked the sealed envelope. And he prepared the sacrococcygeal area using an iodine-based povidone and an alcohol swabs. As a topical pre-CEI anesthesia, the marked site was infiltrated subcutaneously with 3 ml of 2% lidocaine in the local infiltration group. In the spray group, the marked site was sprayed using an vapocoolant spray (Walter Ritter GmbH and Co., Hamburg, Germany) for 10-sec from a distance of 30 cm. To enhance a blind design, 10-sec spray was performed with targeting to the open air after 3 min (time for manifesting the effect of lidocaine) in the local infiltration group. In the spray group, there had been same time interval of 3 min before spraying. Immediately after these procedures, the marked site was prepped again using alcohol swab, then the principal investigator left and the interventionist entered the intervention section. And the interventionist inserted a prepared 20-gauge spinal needle into the marked site and pointed the needle toward the sacral hiatus under ultrasonography (Xario, Toshiba, Otawara, Japan) guided. When neither tissue resistance nor subcutaneous injection was noticed after injecting saline, 15 ml of 0.5% lidocaine and 10 mg of dexamethasone were injected. After finishing the CEI, each patient was asked to fill out the self-administered documents for outcome measures, seal them in an envelope, and submit them to the principal investigator. Outcome Measures Pain induced by spinal needle insertion was assessed using a 100-mm VAS as well as patients' satisfaction about the topical pre-CEI anesthesia using a five-point Likert scale. The 100-mm VAS consisted of a 100-mm horizontal line labeled "no pain" at the left and "worst pain imaginable" at the right. The five-point Likert scale (1, strongly agree; 2, agree; 3, undecided; 4, disagree; and 5, strongly disagree) was used to answer two questions: ''Are you satisfied with the topical pre-CEI anesthesia used before the spinal needle insertion of CEI?'' and ''Will you use the topical pre-CEI anesthesia applied today again if CEI repeated in the future?''

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    66 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vapocoolant spray group
    Arm Type
    Experimental
    Arm Description
    vapocoolant spray was applied for 10 second
    Arm Title
    Local infiltration group
    Arm Type
    Active Comparator
    Arm Description
    3 ml of 2% lidocaine infiltrated subcutaneously
    Intervention Type
    Device
    Intervention Name(s)
    vapocoolant spray
    Intervention Description
    As a topical pre caudal epidural block anesthesia, spinal needle insertion site was sprayed using an vapocoolant spray for 10-sec from a distance of 30 cm
    Intervention Type
    Drug
    Intervention Name(s)
    local infiltration
    Intervention Description
    As a topical pre caudal epidural block anesthesia, spinal needle insertion site was injected subcutaneously using 3ml of 2% lidocaine
    Primary Outcome Measure Information:
    Title
    100mm visual analog scale
    Description
    Pain of spinal needle insertion during caudal epidural injection
    Time Frame
    Up to 20 minutes (Just after caudal epidural injection)
    Secondary Outcome Measure Information:
    Title
    Five point Likert scale
    Description
    five-point Likert scale (1, strongly agree; 2, agree; 3, undecided; 4, disagree; and 5, strongly disagree) was used to answer two questions: ''Are you satisfied with the topical pre-CEI anesthesia used before the spinal needle insertion of CEI?'' and ''Will you use the topical pre-CEI anesthesia applied today again if CEI repeated in the future?''
    Time Frame
    Up to 20 minutes (Just after caudal epidural injection)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with low back pain and radiating pain in the lower limb who underwent a scheduled caudal epidural injection Exclusion Criteria: those who had systemic inflammatory disease, those who take anticoagulant administration, those who had uncontrolled diabetes, those who were unable to understand a visual analog scale (VAS) or a Likert scale, those with a history of cold intolerance or cold allergy, those with a history of allergic reaction to lidocaine, those who took pain medications or had used topical anesthetics within the previous 24 hrs, those who had a skin lesion on the sacral hiatus, and those who had the experience of caudal epidural injection

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Vapocoolant Spray for Reducing the Pain of Spinal Needle Insertion

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