Accuracy of Manual Palpation vs Ultrasound for Spinal Anesthesia

Not Applicable

Completed

• Conditions: Anesthesia, Local; Infant Conditions
• Interventions: Diagnostic Test: Ultrasound

• Registration Number: NCT04757805
• Lead Sponsor: Nationwide Children's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-12
• Study First Posted: 2021-02-17
• Study Start: 2021-05-06
• Primary Completion: 2022-03-21
• Study Completion: 2022-03-21
• Results First Submitted: 2022-08-18
• Results First Submitted QC: 2022-08-18
• Results First Posted: 2022-09-15
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-23
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spinal anesthesia	Ultrasound	Infants receiving spinal anesthesia for standard of care procedure

Primary Outcome Measures

Name	Time	Method
Intended Interspace	Immediately prior to spinal anesthesia	The vertebral interspace that the anesthesia provider believes that they had marked \& identified by manual palpation
Actual Interspace of Provider's Mark	Immediately prior to spinal anesthesia	The actual vertebral interspace that the anesthesia provider marked \& identified, as verified by ultrasound.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States