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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by The Cleveland Clinic.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Sherif Zaky, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01686243
First received: July 18, 2012
Last updated: September 12, 2012
Last verified: September 2012
  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 touhy needles " Pajunk TouhySono"

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 succesful 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 touhy needles (Pajunk TouhySono)
Other: standard epidural placement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • feasability [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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 touhy needles " Pajunk TouhySono"


Estimated Enrollment: 20
Study Start Date: July 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: echogenic 17G touhy needles " Pajunk TouhySono
Epidural will be placed with the aid of ultrasound and echogenic 17G touhy needles (Pajunk TouhySono).
Other: epidural needle placement with echogenic 17G touhy needles (Pajunk TouhySono)
Anesthesiologist will place epidural with aid of ultrasound and placement with echogenic 17G touhy needles (Pajunk TouhySono)
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

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01686243

Contacts
Contact: Sherif Zaky, M.D. 216-445-1072 zakys@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

No publications provided

Responsible Party: Sherif Zaky, M.D., The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01686243     History of Changes
Other Study ID Numbers: 12-560
Study First Received: July 18, 2012
Last Updated: September 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
epidural

ClinicalTrials.gov processed this record on October 19, 2014