Accuracy of Manual Palpation vs Ultrasound for Spinal Anesthesia

• Sponsor: Nationwide Children's Hospital (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04757805
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 18.9
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, Local; Infant Conditions	Diagnostic Test: Ultrasound	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: 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
• Actual Study Start Date: May 6, 2021
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Accuracy of manual palpation [Baseline]

   Whether the interspace marked & identified by manual palpation was the correct space as assessed by ultrasound

Secondary Outcome Measures

1. Level of conus medullaris - lateral [Baseline]

   Assessing the level of the conus medullaris by ultrasound in the lateral position.

2. Level of conus medullaris - sitting [Baseline]

   Assessing the level of the conus medullaris by ultrasound in the sitting position.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 12 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nationwide Children's Hospital	Columbus	Ohio	United States	43205

Sponsors and Collaborators

• Nationwide Children's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Giorgio Veneziano, Associate Professor of Clinical Anesthesiology and Pain Medicine, Nationwide Children's Hospital
• ClinicalTrials.gov Identifier: NCT04757805
• Other Study ID Numbers: STUDY00000558
• First Posted: Feb 17, 2021
• Last Update Posted: Aug 19, 2021
• Last Verified: Aug 1, 2021

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

Study Results

No Results Posted as of Aug 19, 2021