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

Sponsor
The Cleveland Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT01686243
Collaborator
(none)
25
1
2
52.8
0.5

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: epidural needle placement with echogenic 17G Tuohy needles (Pajunk TuohySono)
  • Other: standard epidural placement
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Study Start Date :
Jul 1, 2012
Actual Primary Completion Date :
Nov 25, 2016
Actual Study Completion Date :
Nov 25, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: echogenic 17G tuohy needles " Pajunk TuohySono

Epidural will be placed with the aid of ultrasound and echogenic 17G Tuohy needles (Pajunk TuohySono).

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)

Placebo Comparator: standard epidural needles

Epidural will be placed in standard practice with standard needles.

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

Outcome Measures

Primary Outcome Measures

  1. 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"

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cleveland Clinic Cleveland Ohio United States 44195

Sponsors and Collaborators

  • The Cleveland Clinic

Investigators

  • Principal Investigator: Sherif Zaky, M.D., The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Loran Mounir Solimin, MD, M.D., The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01686243
Other Study ID Numbers:
  • 12-560
First Posted:
Sep 18, 2012
Last Update Posted:
Apr 8, 2019
Last Verified:
Apr 1, 2019
Keywords provided by Loran Mounir Solimin, MD, M.D., The Cleveland Clinic

Study Results

No Results Posted as of Apr 8, 2019