Comparison of Tuohy Needle and Quincke Needle During Caudal Epidural Injection

Not Applicable

Completed

• Conditions: Caudal Epidural Block
• Interventions: Device: Tuohy needle group; Device: Quincke needle group

• Registration Number: NCT05504590
• Lead Sponsor: Gangnam Severance Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-16
• Study First Posted: 2022-08-17
• Study Start: 2022-08-31
• Status Verified: 2022-12
• Primary Completion: 2022-12-21
• Study Completion: 2022-12-21
• Last Update Submitted: 2022-12-22
• Last Update Posted: 2022-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tuohy needle group	Tuohy needle group	Ultrasound-guided caudal epidural block with Touhy needle
Quincke needle group	Quincke needle group	Ultrasound-guided caudal epidural block with Quincke needle

Primary Outcome Measures

Name	Time	Method
incidence of intravascular injection	1 minute after finishing caudal epidural block	incidence of intravascular injection during caudal epidural block

Secondary Outcome Measures

Name	Time	Method
time required to complete caudal epidural block	Baseline, 1 second after the completion of caudal epidural block	time required to complete caudal epidural block

Trial Locations

Locations (1)

GangnamSeverance Hospital; 🇰🇷 Seoul, Korea, Republic of