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Rivanna Ultrasound for Neuraxial Block

NCT03214640 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2021-07-28

Study results available
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Summary

We hypothesize that the Rivanna Accuro or similar U/S device would reduce time to success of identifying epidural and/or intrathecal spaces as compared to conventional palpation method.

Conditions

  • Analgesia

Interventions

DEVICE

Rivanna Accuro US Device

When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Rivanna Accuro U/S device. For subjects in group C-R or L-R, the needle insertion site will be the site identified by the Rivanna Accuro U/S device. After placement of spinal for Cesarean or epidural for labor, the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.

OTHER

Palpation

When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Palpation method using conventional landmarks (spinous process and iliac crest). For subjects in group C-P or L-P, the needle insertion site will be the site identified by the Palpation method. After placement of spinal for Cesarean or epidural for labor, the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.

PROCEDURE

Neuraxial Analgesia

Labor analgesia will be provided utilizing the standard medications to provide labor analgesia

PROCEDURE

Spinal Block

Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Peter Pan, MD, MSEE · Professor, Anesthesiology

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-23
Primary Completion
2019-04-13
Completion
2019-04-13
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03214640 on ClinicalTrials.gov