A Real-Time Ultrasound Guided Approach For Spinal Anesthesia
Primary Purpose
Patients Aged 55 or Older, BMI More Than 40 kg/m2, Scoliosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ultrasound-guided spinal anesthesia
standard spinal anesthesia
Sponsored by
About this trial
This is an interventional supportive care trial for Patients Aged 55 or Older
Eligibility Criteria
Inclusion Criteria:
- Patients aged 55 or older
- BMI more than 40
- Scoliosis
Exclusion criterion:
1 Patients who have undergone previous Spine Surgery
Sites / Locations
- Cleveland Clinic Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ultrasound-guided spinal anesthesia
standard spinal anesthesia
Arm Description
participants will randomly assigned to use ultrasound-guided technique for block placement by Anesthesiologist.
randomized participants will be given standard spinal anesthesia insertion technique for block placement by Anesthesiologist
Outcomes
Primary Outcome Measures
Number of Attempts
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 Outcome Measures
Difficulty of Block Insertion
Difficulty of insertion, was rated by the performing anesthesiologist on a 10-point Likert scale from one (easy) to ten (extremely difficult)
Patient Satisfaction
Record patient satisfaction on a five-point Likert scale, where a value of 1 indicates extremely unsatisfied and a value of 5 indicates extremely satisfied.
Time to Perform Block (Second)
Time to perform block (from first needle insertion to injection of medication)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01570491
Brief Title
A Real-Time Ultrasound Guided Approach For Spinal Anesthesia
Official Title
Cardiothoracic Anesthesia and Critical Care Patient Registry
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 2012 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients Aged 55 or Older, BMI More Than 40 kg/m2, Scoliosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ultrasound-guided spinal anesthesia
Arm Type
Active Comparator
Arm Description
participants will randomly assigned to use ultrasound-guided technique for block placement by Anesthesiologist.
Arm Title
standard spinal anesthesia
Arm Type
Placebo Comparator
Arm Description
randomized participants will be given standard spinal anesthesia insertion technique for block placement by Anesthesiologist
Intervention Type
Other
Intervention Name(s)
ultrasound-guided spinal anesthesia
Intervention Description
ultrasound-guided technique for block placement
Intervention Type
Other
Intervention Name(s)
standard spinal anesthesia
Intervention Description
Anesthesiologist will use standard technique for placement of spinal block.
Primary Outcome Measure Information:
Title
Number of Attempts
Description
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
Time Frame
10-15 minutes before the surgery
Secondary Outcome Measure Information:
Title
Difficulty of Block Insertion
Description
Difficulty of insertion, was rated by the performing anesthesiologist on a 10-point Likert scale from one (easy) to ten (extremely difficult)
Time Frame
10-15 minutes before the surgery
Title
Patient Satisfaction
Description
Record patient satisfaction on a five-point Likert scale, where a value of 1 indicates extremely unsatisfied and a value of 5 indicates extremely satisfied.
Time Frame
after insert the block but before the surgery
Title
Time to Perform Block (Second)
Description
Time to perform block (from first needle insertion to injection of medication)
Time Frame
as measured in seconds after needle insertion, surgical date
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 55 or older
BMI more than 40
Scoliosis
Exclusion criterion:
1 Patients who have undergone previous Spine Surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hesham Elsharkawy, M.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
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A Real-Time Ultrasound Guided Approach For Spinal Anesthesia
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