N/A
N=50
Accuracy of Manual Palpation vs Ultrasound for Spinal Anesthesia
Anesthesia, Local · Infant Conditions
Bottom Line
View on ClinicalTrials.gov: NCT04757805 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Intended Interspace — 1; 24; 25 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ultrasound (Diagnostic_test)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Nationwide Children's Hospital
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intended Interspace |
1; 24; 25 | — |
| PRIMARY Actual Interspace of Provider's Mark |
5; 24; 21 | — |
| SECONDARY Level of Conus Medullaris - Sitting |
9; 27; 9; 3; 2 | — |
| SECONDARY Time to Mark |
25 | — |
| SECONDARY Time to Conduct Ultrasound |
38.5 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04757805). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.