Accuracy of Manual Palpation vs Ultrasound for Spinal Anesthesia

NCT ID: NCT04757805

Last Updated: 2023-01-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-06

Study Completion Date

2022-03-21

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthesia, Local Infant Conditions

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Spinal anesthesia

Infants receiving spinal anesthesia for standard of care procedure

Group Type EXPERIMENTAL

Ultrasound

Intervention Type DIAGNOSTIC_TEST

Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia.

Interventions

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Ultrasound

Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Giorgio Veneziano

Associate Professor of Clinical Anesthesiology and Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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STUDY00000558

Identifier Type: -

Identifier Source: org_study_id

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