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OpenTrials
Completed

NCT Number: NCT01686243

Real-time Ultrasound-guided Paramedian Epidural Access: Evaluation of a Novel In-plane Transverse View Technique

The aim of this study is to demonstrate the feasibility of a new technique using real time ultrasound guided paramedian approach to the epidural space. This approach will use transverse view of the spine utilizing curvilinear low frequency ultrasound probe "Sonosite S nerve" and echogenic 17G tuohy needles " Pajunk TuohySono"

The investigators believe that this new technique is helpful to get the best anatomic landmark for epidural catheter placement using the real-time ultrasound.

Measurable outcomes:

* Block performance time. * Block success rate. * Needle Depth to epidural space

Block success rate will be measured as the rate of cases that will have successful insertion of the epidural catheter using ultrasound guidance and the case is done completely under epidural anesthesia.

All cases that will be converted to general anesthesia will be counted unsuccessful.

Other measurable outcome data that will be collected will include needle depth to the epidural space, and ultrasound measured depth to the lamina

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Key information

Conditions

Epidural Placement

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult Patients 30 to 80 years old at time of surgery.
  • Patients in whom epidural anesthesia is planned to be used as the for surgery " Surgical epidural"

Exclusion criteria

  • Current or recent drug abuse (within past 6 months).
  • Allergy to local anesthetics
  • Patient refusal.

Treatment and study plan

epidural needle placement with echogenic 17G Tuohy needles (Pajunk TuohySono)

Other

Anesthesiologist will place epidural with aid of ultrasound and placement with echogenic 17G Tuohy needles (Pajunk TuohySono)

standard epidural placement

Other

Anesthesiologist will place epidural within standard practice, with standard needles.

Primary outcomes

  1. Real-time ultrasound-guided paramedian epidural access:

    Time frame: Day 1

    Block success rate will be measured as the rate of cases that will have succesful insertion of the epidural catheter using ultrasound guidance and the case is done completely under epidural anesthesia. The aim of this study is to demonstrate the feasibility of a new technique using real time ultrasound guided paramedian approach to the epidural space. This approach will use transverse view of the spine utilizing curvilinear low frequency ultrasound probe "Sonosite S nerve" and echogenic 17G tuohy needles " Pajunk TuohySono"

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Sep 18, 2012
Registry last updated
Apr 8, 2019

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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