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

NeuroTherapia, Inc.

Status: Completed

Conditions: Epidural Placement

Treatments: Other: standard epidural placement; Other: epidural needle placement with echogenic 17G Tuohy needles (Pajunk TuohySono)

Study type: Interventional

Funder types: Other

Identifiers

NCT01686243

12-560

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups, including a placebo group

echogenic 17G tuohy needles " Pajunk TuohySono

Experimental group

Description:

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

Treatment:

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

standard epidural needles

Placebo Comparator group

Description:

Epidural will be placed in standard practice with standard needles.

Treatment:

Other: standard epidural placement