Rivanna Ultrasound for Neuraxial Block

Status Completed

Clinical Trial 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.

Clinical Trial Description

Administration of (neuraxial blocks) spinal and epidural blocks is commonly achieved by first palpating the landmarks for midline with spinous process and iliac crest for L3-4-5 intervertebral spaces. With an epidural block, a loss of resistance in a pressurized syringe is used to incrementally advance the epidural needle until identification of epidural space with loss of resistance in the pressurized syringe. With a spinal block, the spinal needle is advanced incrementally until a noted "feel" of dural puncture together with return of spinal fluid via the spinal needle. The palpation technique and somewhat "blind" technique to identify the spinal and epidural spaces become more difficult and less reliable particularly with the increasing prevalence of the morbid and super-morbid obese patients. Ultrasound devices have become common and successful with non-neuraxial blocks and venous accesses, both involving mostly non-bony, soft tissues. Application of conventional ultrasound for neuraxial blocks has been limited by its bulkiness, limited imaging for bony structures and lack of automated artificial intelligent algorithm for pattern recognition. Recent technological advancement has addressed the aforementioned limitations. Rivanna Accuro is one such device that has gained FDA approval and may have helped in addressing some of these issues. It is a handheld (pocket size) U/S device with real time pattern recognition for bony structures such as the spine while providing 3-D overlay for recognition of the midline spinous process and epidural spaces and distance. The investigators 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. We will compare placement of neuraxial block between palpation method versus ultrasound method. We will compare placement of spinal block for cesarean delivery with palpation versus with ultrasound method, and then comparing placement of neuraxial analgeisa block (combined spinal epidural analgesia) for labor analgesia with palpation versus ultrasound method. ;

Study Design

Related Conditions & MeSH terms

Analgesia

Clinical Trial Details

NCT number	NCT03214640
Study type	Interventional
Source	Wake Forest University Health Sciences
Contact
Status	Completed
Phase	N/A
Start date	October 23, 2017
Completion date	April 13, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.