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
About this trial
This is an interventional treatment trial for Low Back Pain
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
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
NCT ID
NCT03175913
First Posted
May 30, 2017
Last Updated
June 11, 2017
Sponsor
The Catholic University of Korea
Collaborators
Soonchunhyang University Hospital
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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