A Real-Time Ultrasound Guided Approach For Spinal Anesthesia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cardiothoracic Anesthesia and Critical Care Patient Registry

Conditions
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Patients Aged 55 or Older, BMI More Than 40 kg/m2, Scoliosis

Intervention / Treatment
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* Other: ultrasound-guided spinal anesthesia
* Other: standard spinal anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 55 or older BMI more than 40 Scoliosis Exclusion criterion: 1 Patients who have undergone previous Spine Surgery

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ultrasound-guided spinal anesthesia<br>participants will randomly assigned to use ultrasound-guided technique for block placement by Anesthesiologist. | Other: ultrasound-guided spinal anesthesia<br>* ultrasound-guided technique for block placement<br>|
| Placebo Comparator: standard spinal anesthesia<br>randomized participants will be given standard spinal anesthesia insertion technique for block placement by Anesthesiologist | Other: standard spinal anesthesia<br>* Anesthesiologist will use standard technique for placement of spinal block.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 10-15 minutes before the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 10-15 minutes before the surgery | 
| 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. | after insert the block but before the surgery | 
| Time to Perform Block (Second) | Time to perform block (from first needle insertion to injection of medication) | as measured in seconds after needle insertion, surgical date |