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

This study is currently recruiting participants.
Verified October 2017 by Loran Mounir Solimin, MD, The Cleveland Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT01686243
First Posted: September 18, 2012
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Loran Mounir Solimin, MD, The Cleveland Clinic
  Purpose

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 Intervention
Epidural Placement Other: epidural needle placement with echogenic 17G Tuohy needles (Pajunk TuohySono) Other: standard epidural placement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science

Further study details as provided by Loran Mounir Solimin, MD, The Cleveland Clinic:

Primary Outcome Measures:
  • feasibility [ Time Frame: Day 1 ]
    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"


Estimated Enrollment: 25
Study Start Date: July 2012
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01686243


Contacts
Contact: Sherif Zaky, M.D. 216-445-1072 zakys@ccf.org
Contact: Roberta Johnson 216-444-9950 johnsor13@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Sherif Zaky, M.D.    216-445-1072    zakys@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Sherif Zaky, M.D. The Cleveland Clinic
  More Information

Responsible Party: Loran Mounir Solimin, MD, M.D., The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01686243     History of Changes
Other Study ID Numbers: 12-560
First Submitted: July 18, 2012
First Posted: September 18, 2012
Last Update Posted: November 6, 2017
Last Verified: October 2017

Keywords provided by Loran Mounir Solimin, MD, The Cleveland Clinic:
epidural