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Completed

NCT Number: NCT05504590

Comparison of Tuohy Needle and Quincke Needle During Caudal Epidural Injection

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GangnamSeverance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Tuohy needle group

Device

Ultrasound-guided caudal epidural block with Touhy needle

Quincke needle group

Device

Ultrasound-guided caudal epidural block with Quincke needle

Primary outcomes

  1. incidence of intravascular injection

    Time frame: 1 minute after finishing caudal epidural block

    incidence of intravascular injection during caudal epidural block

Secondary outcomes

  1. time required to complete caudal epidural block

    Time frame: Baseline, 1 second after the completion of caudal epidural block

    time required to complete caudal epidural block

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 17, 2022
Registry last updated
Dec 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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