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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01686243
Enrollment
25
Registered
2012-09-18
Start date
2012-07-31
Completion date
2016-11-25
Last updated
2019-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidural Placement

Keywords

epidural

Brief summary

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

Interventions

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

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

OTHERstandard epidural placement

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

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Real-time ultrasound-guided paramedian epidural access:Day 1Block 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026