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OpenTrials
Completed

NCT Number: NCT04757805

Accuracy of Manual Palpation vs Ultrasound for Spinal Anesthesia

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.

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Key information

Conditions

Anesthesia, Local Infant Conditions

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound

Diagnostic Test

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

Primary outcomes

  1. Intended Interspace

    Time frame: Immediately prior to spinal anesthesia

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

  2. Actual Interspace of Provider's Mark

    Time frame: Immediately prior to spinal anesthesia

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

Secondary outcomes

  1. Level of Conus Medullaris - Sitting

    Time frame: Immediately prior to spinal anesthesia

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

  2. Time to Mark

    Time frame: Immediately prior to spinal anesthesia

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

  3. Time to Conduct Ultrasound

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 17, 2021
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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