Study:
n/a
Rationale:
n/a
Purpose:
200 patients undergoing elective total joint arthroplasty of the lower extremity will be
studied in both the ultrasound guided and the standard technique group (total sample size of
N=400). Patients who consent to receive spinal anesthesia (as opposed to some other
anesthetic technique) and who meet the inclusion/exclusion criteria for the study (given
below) will be randomized on day of surgery after obtaining informed consent to either
ultrasound-guided or standard spinal anesthesia technique. A block randomization scheme
with random block sizes ranging from 2-8 patients will be used. The outcomes will be
recorded by a third party observer in the block room/operating room who might be a nurse or
resident or clinical research fellow not directly involved with performing the block. The
post procedure outcomes will also be recorded by a clinical research fellow or resident who
was not directly involved with performing the block. The analysis will be conducted by a
statistician who will be blinded.
Study Status: Recruiting
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Patients Aged 55 or Older
BMI More Than 40 kg/m2
Scoliosis |
Other: ultrasound guided placement spinal block
Other: standard spinal anesthesia |
N/A |
Verified by
The Cleveland Clinic
December, 2012
Sponsored by: The Cleveland Clinic
Information provided by: The Cleveland Clinic
ClinicalTrials.gov identifier: NCT01570491
Study Type: Interventional
Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Hesham Elsharkawy, M.D.., Principal Investigator