Accuracy of Manual Palpation vs Ultrasound for Spinal Anesthesia

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local; Infant Conditions
• Intervention / Treatment: Diagnostic test: Ultrasound

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spinal anesthesia; Infants receiving spinal anesthesia for standard of care procedure	Diagnostic test: Ultrasound; Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2021
• Primary Completion (Actual): March 21, 2022
• Study Completion (Actual): March 21, 2022

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00000558

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No