Accuracy of Manual Palpation vs Ultrasound for Spinal Anesthesia

Study Overview
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Brief Summary
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Although the current standard for lumbar puncture and spinal anesthesia is the use of manual palpation of surface landmarks to identify the correct interspace, performance of the procedure at too high of a level may increase the incidence of adverse effects. The current study will evaluate the efficacy of ultrasound in identifying the correct intervertebral space for lumbar puncture thereby improving the safety of the procedure.

Official Title
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Assessment of the Accuracy of the Manual Palpation of Surface Landmarks Versus Ultrasound for Identification of the Correct Intervertebral Space for Spinal Anesthesia in Children Less Than 1 Year of Age

Conditions
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Anesthesia, Local, Infant Conditions

Intervention / Treatment
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* Diagnostic Test: Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients less than 1 year of age scheduled for spinal anesthesia for elective lower abdominal, urologic, or lower extremity surgery at Nationwide Children's Hospital Exclusion Criteria: Parents unwilling for their children to undergo spinal anesthesia for surgery. Children with known spinal anomalies including sacral dimple. Children with coagulation abnormalities or receiving anticoagulation which precludes the use of spinal anesthesia. Children with superficial or deep infections over the spine which precludes the use of spinal anesthesia.

Ages Eligible for Study
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Maximum Age: 12 Months

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal anesthesia<br>Infants receiving spinal anesthesia for standard of care procedure | Diagnostic Test: Ultrasound<br>* Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intended Interspace | The vertebral interspace that the anesthesia provider believes that they had marked & identified by manual palpation | Immediately prior to spinal anesthesia | 
| Actual Interspace of Provider's Mark | The actual vertebral interspace that the anesthesia provider marked & identified, as verified by ultrasound. | Immediately prior to spinal anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Conus Medullaris - Sitting | Assessing the level of the conus medullaris by ultrasound in the sitting position. | Immediately prior to spinal anesthesia | 
| Time to Mark | The amount of time if took for the anesthesia provider to manually palpate and mark the desired interspace. | Immediately prior to spinal anesthesia | 
| Time to Conduct Ultrasound | The amount of time it took for the investigator to identify the actual space that the provider marked using ultrasound. | Immediately prior to spinal anesthesia |