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

Not Applicable

Completed

• Conditions: Epidural Placement
• Interventions: Other: standard epidural placement; Other: epidural needle placement with echogenic 17G Tuohy needles (Pajunk TuohySono)

• Registration Number: NCT01686243
• Lead Sponsor: The Cleveland Clinic

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-18
• Study First Submitted QC: 2012-09-12
• Study First Posted: 2012-09-18
• Primary Completion: 2016-11-25
• Study Completion: 2016-11-25
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-04
• Last Update Posted: 2019-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard epidural needles	standard epidural placement	Epidural will be placed in standard practice with standard needles.
echogenic 17G tuohy needles " Pajunk TuohySono	epidural needle placement with echogenic 17G Tuohy needles (Pajunk TuohySono)	Epidural will be placed with the aid of ultrasound and echogenic 17G Tuohy needles (Pajunk TuohySono).

Primary Outcome Measures

Name	Time	Method
Real-time ultrasound-guided paramedian epidural access:	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"

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States