Comparison of Tuohy Needle and Quincke Needle During Caudal Epidural Injection

Comparison of Tuohy Needle and Quincke Needle on the Incidence of Intravascular Injection During Caudal Epidural Injection Under Ultrasound Guidance: Prospective Randomized Controlled Study

Park et al. reported the results of a randomized study of the use of ultrasound and the use of C-arm in caudal epidural block. However, it is difficult to determine the overall epidural space contrast agent spread with ultrasound alone, and intravascular injection can be avoided with ultrasound. It was said that the evidence for the efficacy of exclusion of intravascular infusion was not as good as that of the C-arm. Therefore, it was suggested that ultrasound in caudal epidural block should be considered only when it is difficult to use the C-arm as an auxiliary means to guide the needle when the sacral hiatus is less than 2 mm and has a complex anatomical structure. The purpose of this study is to determine the difference between intravascular injection and epidural spread according to the type of needle during caudal block under ultrasound guidance.

Study Overview

• Status: Completed
• Conditions: Caudal Epidural Block
• Intervention / Treatment: Device: Tuohy needle group; Device: Quincke needle group

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • GangnamSeverance Hospital

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:

1. A patient who visited the pain clinic complaining of lower back pain due to lumbar disc/stenosis
2. When NRS of back and/or radiating pain is 4 or more
3. Patients over 19 years of age

Exclusion Criteria:

1. Malignancy
2. Systemic infection
3. Bleeding tendency
4. Contrast Allergy
5. Pregnant women
6. If you cannot read or agree to the consent form
7. If you cannot sign the consent form yourself

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: Tuohy needle group; Ultrasound-guided caudal epidural block with Touhy needle	Device: Tuohy needle group; Ultrasound-guided caudal epidural block with Touhy needle
Active Comparator: Quincke needle group; Ultrasound-guided caudal epidural block with Quincke needle	Device: Quincke needle group; Ultrasound-guided caudal epidural block with Quincke needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of intravascular injection	incidence of intravascular injection during caudal epidural block	1 minute after finishing caudal epidural block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time required to complete caudal epidural block	time required to complete caudal epidural block	Baseline, 1 second after the completion of caudal epidural block

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2022
• Primary Completion (Actual): December 21, 2022
• Study Completion (Actual): December 21, 2022

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 16, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): December 27, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 3-2022-0238

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: No