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Clinical Trials/NCT01570491
NCT01570491
Completed
N/A

Cardiothoracic Anesthesia and Critical Care Patient Registry

The Cleveland Clinic1 site in 1 country38 target enrollmentMarch 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Patients Aged 55 or Older
Sponsor
The Cleveland Clinic
Enrollment
38
Locations
1
Primary Endpoint
Number of Attempts
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Our goal was to compare the number of attempts to perform spinal anesthesia using real-time ultrasound guidance versus landmark technique in patients meeting predefined criteria for difficult spinal anesthesia.

Detailed Description

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. No sample size estimation methodology currently exists for the right-censored count data models. We expect less number of attempts in the ultrasound group a 20 % difference between the two groups which we feel is a minimum of a clinically-relevant effect. At the 0.05 level of significance with a power of 0.8, we will require a minimum of 20 patients per group,therefore we plan to recruit 40 patients in total. The analysis will be conducted by a statistician who will be blinded.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
December 2016
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients aged 55 or older
  • BMI more than 40
  • Exclusion criterion:
  • 1 Patients who have undergone previous Spine Surgery

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Number of Attempts

Time Frame: 10-15 minutes before the surgery

Number of attempts (defined as number of needle reinsertions form the skin and NOT number of redirection of the needle) at the beginning of surgery

Secondary Outcomes

  • Time to Perform Block (Second)(as measured in seconds after needle insertion, surgical date)
  • Difficulty of Block Insertion(10-15 minutes before the surgery)
  • Patient Satisfaction(after insert the block but before the surgery)

Study Sites (1)

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