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

NCT ID: NCT01686243

Last Updated: 2019-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2016-11-25

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

echogenic 17G tuohy needles " Pajunk TuohySono

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

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

standard epidural needles

Epidural will be placed in standard practice with standard needles.

Group Type: PLACEBO_COMPARATOR

standard epidural placement

Intervention Type: OTHER

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

Interventions

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)

Intervention Type: OTHER

standard epidural placement

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Loran Mounir Solimin, MD

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sherif Zaky, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30865772 (View on PubMed)

Other Identifiers

12-560

Identifier Type: -

Identifier Source: org_study_id