An observational study in Ultrasound Spinal Anesthesia, sponsored by Sunnybrook Health Sciences Centre. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-06.
Sponsored by Sunnybrook Health Sciences Centre · Observational
The traditional landmarks to locate the injection site and orientation of the spinal needle for spinal anesthesia are based on palpation of surface bony landmarks. However the actual injection target into the CSF is located at an unknown depth inside the patients 3 dimensional spinal anatomy which can itself vary in its orientation relative to these surface markers.Also bony surface markers may not be palpable in some patients or the patient may have altered spinal alignment. Thus an already blind procedure can become even more misguided involving multiple trial and error needle insertions. On the other hand ultrasound allows visualisation of deep target structures which are impalpable, it allows assessment of spinal alignment and thus directs the orientation of the seeking needle more accurately. Performing US in real-time during needle insertion gives continuous feedback about the correct needle approach path which should reduce the number of blind needle passes.
Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 133 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients presenting for elective lower limb orthopaedic surgery to a specialist orthopaedic hospital.
Inclusion Criteria:
Exclusion Criteria (are as for Spinal anesthesia generally)
Patients of at least 18 years of age undergoing spinal anesthesia for elective lower limb surgery will be recruited. Therefore inclusion and exclusion criteria are the same as for traditionally administered spinal anesthesia as below. Additionally we will exclude those patients who are incapable of providing fully informed consent, patients who are currently enrolled in other studies and patients with communication difficulties
Procedure: Real-time ultrasound guided spinal anesthesia
The neuraxial US scan will be performed with the patient in the sitting or lateral position with the hip and knees slightly flexed using full aseptic technique. The spinal needle will be inserted in real-time under direct ultrasound guidance to administer the spinal anesthetic.
Number of ventral passes of the spinal needle into the patient
Time frame: Assessed at time of spinal anesthetic injection (baseline)
Rate of successful performance of real-time ultrasound guided spinal needle insertion
Time frame: Assessed at time of spinal anesthetic injection (baseline)
Time for the procedure from first needle contact to the skin to injection of the medication into the spinal canal
Time frame: Assessed at time of spinal anesthetic injection (baseline)
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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Sunnybrook Health Sciences Centre