Vapocoolant Spray for Reducing the Pain of Spinal Needle Insertion

Ocoolant Spray vs Lidocaine Infiltration for Reducing the Pain of Spinal Needle Insertion During the Caudal Epidural Injection

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Device: vapocoolant spray; Drug: local infiltration

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?''

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vapocoolant spray group; vapocoolant spray was applied for 10 second	Device: vapocoolant spray; 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
Active Comparator: Local infiltration group; 3 ml of 2% lidocaine infiltrated subcutaneously	Drug: local infiltration; As a topical pre caudal epidural block anesthesia, spinal needle insertion site was injected subcutaneously using 3ml of 2% lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
100mm visual analog scale	Pain of spinal needle insertion during caudal epidural injection	Up to 20 minutes (Just after caudal epidural injection)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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?''	Up to 20 minutes (Just after caudal epidural injection)

Collaborators and Investigators

• Sponsor: The Catholic University of Korea
• Collaborators: Soonchunhyang University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: May 30, 2017
• First Submitted That Met QC Criteria: June 2, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 11, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 201406018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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