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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ultrasound-guided spinal anesthesia | Active Comparator | participants will randomly assigned to use ultrasound-guided technique for block placement by Anesthesiologist. |
|
| standard spinal anesthesia | Placebo Comparator | randomized participants will be given standard spinal anesthesia insertion technique for block placement by Anesthesiologist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrasound-guided spinal anesthesia | Other | ultrasound-guided technique for block placement |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion criterion:
1 Patients who have undergone previous Spine Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Hesham Elsharkawy, M.D. | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
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patients were recruited and enrolled from 4/2012 to 10/2012 at Cleveland clinic, main campus.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ultrasound-guided Spinal Anesthesia | Anesthesiologist will use ultrasound-guided technique for spinal anesthesia block placement. ultrasound guided placement spinal block: Anesthesiologist will use ultrasound as a guide for placement of spinal block. |
| FG001 | Standard Spinal Anesthesia | Anesthesiologist will use standard spinal anesthesia insertion technique for block placement. standard spinal anesthesia: Anesthesiologist will use standard technique for placement of spinal block. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ultrasound-guided Spinal Anesthesia | Anesthesiologist will use ultrasound-guided technique for spinal anesthesia block placement. ultrasound guided placement spinal block: Anesthesiologist will use ultrasound as a guide for placement of spinal block. |
| BG001 | Standard Spinal Anesthesia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Median | Inter-Quartile Range | Attempts | 10-15 minutes before the surgery |
|
from date of surgery to hospital discharge, on average of 1 week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ultrasound-guided Spinal Anesthesia | Anesthesiologist will use ultrasound-guided technique for spinal anesthesia block placement. ultrasound guided placement spinal block: Anesthesiologist will use ultrasound as a guide for placement of spinal block. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Sessler, MD | Cleveland Clinic | 2164444900 | sessled@ccf.org |
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| standard spinal anesthesia | Other | Anesthesiologist will use standard technique for placement of spinal block. |
|
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 |
Anesthesiologist will use standard spinal anesthesia insertion technique for block placement. standard spinal anesthesia: Anesthesiologist will use standard technique for placement of spinal block. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Secondary | 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) | Posted | Median | Inter-Quartile Range | units on a scale | 10-15 minutes before the surgery |
|
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | after insert the block but before the surgery |
|
|
|
|
| Secondary | Time to Perform Block (Second) | Time to perform block (from first needle insertion to injection of medication) | Posted | Median | Inter-Quartile Range | second | as measured in seconds after needle insertion, surgical date |
|
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Standard Spinal Anesthesia | Anesthesiologist will use standard spinal anesthesia insertion technique for block placement. standard spinal anesthesia: Anesthesiologist will use standard technique for placement of spinal block. | 0 | 18 | 0 | 18 | 0 | 18 |
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