Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04214574 |
| Other study ID # |
BIO-2018-0589 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 15, 2020 |
| Est. completion date |
August 2024 |
Study information
| Verified date |
June 2024 |
| Source |
American University of Beirut Medical Center |
| Contact |
Marwan Rizk, MD |
| Phone |
+961 01 350 000 |
| Email |
mr04[@]aub.edu.lb |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In this prospective randomized observational study, we aim to compare real time
ultrasound-guided paramedian technique using parasagittal oblique view with real time
ultrasound-guided paramedian technique using the paramedian transverse median view. Our aim
is to find the most suitable real time ultrasound guided approach with regard to ease of
performance defined as success rate at first attempt, number of puncture attempts, spinal
procedure time, and patient satisfaction.
Description:
Background: Since its first introduction in 1898 by Bier, Spinal anesthesia has been
performed using the anatomical landmark guided approach. Despite being useful, the landmark
technique doesn't take into account anatomical variations, spine abnormalities or age-related
changes in the lumbar spine as seen in elderly, obese or pregnant patients and thus can lead
to incorrect identification of a certain interspace. Neuraxial ultrasonography has been
introduced as a technique to allow the operator to preview spinal anatomy, identify the
midline, determine the interspace and guide the needle insertion site and trajectory. It was
found to be a feasible and promising technique that can result in successful cerebrospinal
fluid acquisition where other methods have failed.
While pre-procedural Ultrasound has been used by many studies to identify the right epidural
or subarachnoid spaces and have an idea about the angle of needle insertion, it remains a
blind technique. Real-time ultrasound guided technique was found to improve the limitations
of the pre-puncture ultrasound guided techniques by direct, real-time visualization of the
needle trajectory.
In spinal anesthesia, a midline approach has been the most common technique used for needle
insertion. However, this approach is often technically difficult in the geriatric population
because of poorly palpable surface landmarks, lumbar scoliosis, marked thoracic kyphosis,
degenerative changes and inability to flex the lumbar spine in the sitting position. While
the parasagittal oblique approach tends to provide a better sonographic window into the
vertebral canal than the midline approach, it is still not evident whether it will lead to an
easier paramedian needle insertion. In the literature, there are no studies directly
comparing the paramedian transverse and parasagittal oblique approaches in the performance of
real time ultrasound guided spinal anesthesia.
Specific Aim: The aim of this study is to find out the optimal approach to perform spinal
anesthesia under real time ultrasound guidance in the elderly population. Thus, we will
compare real time ultrasound-guided paramedian approach using parasagittal oblique view with
real time ultrasound guided paramedian approach using the paramedian transverse median view.
The aim is thus to adopt a real time ultrasound guided technique that will result in an
easier access to the subarachnoid space in patients with difficult anatomy and results in
better patient satisfaction and less discomfort.
Methodology and analysis: In a prospective randomized observational study, 84 patients
scheduled for surgery amenable to spinal anesthesia, aged more than 65 years, with American
Society of Anesthesiologists physical status 1 to 3 will be assigned to receive spinal
anesthesia to one of two treatment groups: real time ultrasound-guided parasagittal oblique
technique (group RTU-PO) or Real time ultrasound-guided paramedian transverse technique
(group RTU-T). Ultrasonography of the lumbar spine and Real time spinal blockade will be
performed by the experienced anesthesiologist. Patients in both groups will have an
ultrasound scan of the lumbar spine to measure the depth of the dura, to specify and guide
the needle insertion site and trajectory. The primary outcome is the rate of successful dural
puncture on the first needle insertion attempt under real time ultrasound guidance. Normally
distributed data will be summarized as mean ± SD and nonnormally distributed data will be
summarized as median [interquartile range].
Significance: We believe that real time US-guided technique is a superior modality of
performance of spinal anesthesia. However, we would like to evaluate which approach will be
better for the acquisition of cerebrospinal fluid in elderly patients. We think that this
study would have an impact on our current practice in term of introducing real time
ultrasound guided technique into everyday practice and determining the best approach to
perform a successful neuraxial block in a patient with a suspected difficult back. The
anticipated benefits to subjects will be demonstrated by a higher success rate from first
attempt, lower number of puncture attempts, reduced spinal procedure time, and higher patient
satisfaction.
