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

NCT01686243 | Completed

• 1 other identifier: 12-560
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Epidural Placement

Keywords

epidural

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

echogenic 17G tuohy needles " Pajunk TuohySono

EXPERIMENTAL

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)

standard epidural needles

PLACEBO COMPARATOR

Epidural will be placed in standard practice with standard needles.

Other: standard epidural placement

Interventions

epidural needle placement with echogenic 17G Tuohy needles (Pajunk TuohySono) OTHER

Anesthesiologist will place epidural with aid of ultrasound and placement with echogenic 17G Tuohy needles (Pajunk TuohySono)

echogenic 17G tuohy needles " Pajunk TuohySono

standard epidural placement OTHER

Anesthesiologist will place epidural within standard practice, with standard needles.

standard epidural needles

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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"

You may not qualify if:

• Current or recent drug abuse (within past 6 months).
• Allergy to local anesthetics
• Patient refusal.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Elsharkawy H, Saasouh W, Babazade R, Soliman LM, Horn JL, Zaky S. Real-time Ultrasound-Guided Lumbar Epidural with Transverse Interlaminar View: Evaluation of an In-Plane Technique. Pain Med. 2019 Sep 1;20(9):1750-1755. doi: 10.1093/pm/pnz026.

  PMID: 30865772 DERIVED

Study Officials

• Sherif Zaky, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: July 18, 2012
• First Posted: September 18, 2012
• Study Start: July 1, 2012
• Primary Completion: November 25, 2016
• Study Completion: November 25, 2016
• Last Updated: April 8, 2019

Record last verified: 2019-04

Locations

US (1)