Vapocoolant Spray for Reducing the Pain of Spinal Needle Insertion

NCT03175913 | Completed FDA Device

• 1 other identifier: 201406018
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 100mm visual analog scale

  Pain of spinal needle insertion during caudal epidural injection

  Up to 20 minutes (Just after caudal epidural injection)

Secondary Outcomes (1)

• Five point Likert scale

  Up to 20 minutes (Just after caudal epidural injection)

Study Arms (2)

Vapocoolant spray group

EXPERIMENTAL

vapocoolant spray was applied for 10 second

Device: vapocoolant spray

Local infiltration group

ACTIVE COMPARATOR

3 ml of 2% lidocaine infiltrated subcutaneously

Drug: local infiltration

Interventions

vapocoolant spray DEVICE

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

Vapocoolant spray group

local infiltration DRUG

As a topical pre caudal epidural block anesthesia, spinal needle insertion site was injected subcutaneously using 3ml of 2% lidocaine

Local infiltration group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Catholic University of Korea: lead
• Soonchunhyang University Hospital: collaborator

MeSH Terms

Conditions

Low Back Pain

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 5, 2017
• Study Start: June 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 14, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share