NCT04757805

Accuracy of Manual Palpation vs Ultrasound for Spinal Anesthesia

Completed NA Results posted Last updated 26 January 2023

What this trial tests

NA trial testing Ultrasound in Anesthesia, Local in 50 participants. Completed in 21 March 2022.

Timeline

6 May 2021

Primary endpoint
21 March 2022

21 March 2022

Quick facts

Lead sponsor	Nationwide Children's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	50
Start date	6 May 2021
Primary completion	21 March 2022
Estimated completion	21 March 2022
Sites	1 location across United States

Drugs / interventions tested

• Ultrasound

Conditions studied

• Anesthesia, Local — all drugs for Anesthesia, Local →
• Infant Conditions — all drugs for Infant Conditions →

Sponsor

Nationwide Children's Hospital

Who can join

Under 12 Months, any sex, with Anesthesia, Local or Infant Conditions. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Intended Interspace Primary · Immediately prior to spinal anesthesia

The vertebral interspace that the anesthesia provider believes that they had marked \& identified by manual palpation

L2-3

Group	Value	95% CI
Spinal Anesthesia	1

L3-4

Group	Value	95% CI
Spinal Anesthesia	24

L4-5

Group	Value	95% CI
Spinal Anesthesia	25

Actual Interspace of Provider's Mark Primary · Immediately prior to spinal anesthesia

The actual vertebral interspace that the anesthesia provider marked \& identified, as verified by ultrasound.

L2-3

Group	Value	95% CI
Spinal Anesthesia	5

L3-4

Group	Value	95% CI
Spinal Anesthesia	24

L4-5

Group	Value	95% CI
Spinal Anesthesia	21

Level of Conus Medullaris - Sitting Secondary · Immediately prior to spinal anesthesia

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

T12-L1

Group	Value	95% CI
Spinal Anesthesia	9

L1-2

Group	Value	95% CI
Spinal Anesthesia	27

L2-3

Group	Value	95% CI
Spinal Anesthesia	9

L3-4

Group	Value	95% CI
Spinal Anesthesia	3

Unable to obtain

Group	Value	95% CI
Spinal Anesthesia	2

Time to Mark Secondary · Immediately prior to spinal anesthesia

The amount of time if took for the anesthesia provider to manually palpate and mark the desired interspace.

Group	Value	95% CI
Spinal Anesthesia	25	14.3 – 32

Time to Conduct Ultrasound Secondary · 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.

Group	Value	95% CI
Spinal Anesthesia	38.5	29 – 63.8

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Manual Palpation versus Ultrasound to Identify the Intervertebral Space for Spinal Anesthesia in Infants.
   Du J, Roth C, Dontukurthy S, Tobias JD, et al · · 2023 · cited 2× · PMID 36647435 · DOI 10.2147/jpr.s392438