Comparison of Tuohy Needle and Quincke Needle During Caudal Epidural Injection

NCT05504590 | Completed

• 1 other identifier: 3-2022-0238
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Caudal Epidural Block

Outcome Measures

Primary Outcomes (1)

• incidence of intravascular injection

  incidence of intravascular injection during caudal epidural block

  1 minute after finishing caudal epidural block

Secondary Outcomes (1)

• time required to complete caudal epidural block

  Baseline, 1 second after the completion of caudal epidural block

Study Arms (2)

Tuohy needle group

EXPERIMENTAL

Ultrasound-guided caudal epidural block with Touhy needle

Device: Tuohy needle group

Quincke needle group

ACTIVE COMPARATOR

Ultrasound-guided caudal epidural block with Quincke needle

Device: Quincke needle group

Interventions

Tuohy needle group DEVICE

Ultrasound-guided caudal epidural block with Touhy needle

Tuohy needle group

Quincke needle group DEVICE

Ultrasound-guided caudal epidural block with Quincke needle

Quincke needle group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Malignancy
• Systemic infection
• Bleeding tendency
• Contrast Allergy
• Pregnant women
• If you cannot read or agree to the consent form
• If you cannot sign the consent form yourself

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

GangnamSeverance Hospital

Seoul, South Korea

Location

Related Publications (1)

• Kim JY, Lee JS, Kim JY, Baek JW, Kim HS, Kim DH. Comparison of the incidence of intravascular injection using the Tuohy and Quincke needles during ultrasound-guided caudal epidural block: a prospective randomized controlled study. Reg Anesth Pain Med. 2024 Jan 11;49(1):17-22. doi: 10.1136/rapm-2023-104504.

  PMID: 37169489 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 17, 2022
• Study Start: August 31, 2022
• Primary Completion: December 21, 2022
• Study Completion: December 21, 2022
• Last Updated: December 27, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)