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

Epidural Placement Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01686243
• Other study ID #: 12-560
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: November 25, 2016

Study information

• Verified date: April 2019
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 25, 2016
• Est. primary completion date: November 25, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epidural Placement

Intervention

Other:
• epidural 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)
• standard epidural placement
Anesthesiologist will place epidural within standard practice, with standard needles.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Real-time ultrasound-guided paramedian epidural access:	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"	Day 1