Comparison of Tuohy Needle and Quincke Needle During Caudal Epidural Injection

• Sponsor: Gangnam Severance Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05504590
• Collaborator: (none)
• Enrollment: 230
• Arms: 2
• Anticipated Duration (Months): 23.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Caudal Epidural Block	Device: Tuohy needle group; Device: Quincke needle group	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 230 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Double
• Primary Purpose: Treatment
• Official Title: Comparison of Tuohy Needle and Quincke Needle on the Incidence of Intravascular Injection During Caudal Epidural Injection Under Ultrasound Guidance: Prospective Randomized Controlled Study
• Anticipated Study Start Date: Aug 16, 2022
• Anticipated Primary Completion Date: Aug 5, 2024
• Anticipated Study Completion Date: Aug 5, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. incidence of intravascular injection [1 minute after finishing caudal epidural block]

   incidence of intravascular injection during caudal epidural block

Secondary Outcome Measures

1. time required to complete caudal epidural block [Baseline, 1 second after the completion of caudal epidural block]

   time required to complete caudal epidural block

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Do-Hyeong Kim, Associate Professor, Gangnam Severance Hospital
• ClinicalTrials.gov Identifier: NCT05504590
• Other Study ID Numbers: 3-2022-0238
• First Posted: Aug 17, 2022
• Last Update Posted: Aug 17, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 17, 2022