Accuracy of Manual Palpation vs Ultrasound for Spinal Anesthesia

Anesthesia, Local Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04757805
• Other study ID #: STUDY00000558
• Status: Completed
• Phase: N/A
• Start date: May 6, 2021
• Est. completion date: March 21, 2022

Study information

• Verified date: January 2023
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 21, 2022
• Est. primary completion date: March 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Local
• Infant Conditions

Intervention

Diagnostic Test:
• Ultrasound
Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intended Interspace	The vertebral interspace that the anesthesia provider believes that they had marked & identified by manual palpation	Immediately prior to spinal anesthesia
Primary	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	Level of Conus Medullaris - Sitting	Assessing the level of the conus medullaris by ultrasound in the sitting position.	Immediately prior to spinal anesthesia
Secondary	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
Secondary	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