Rivanna Ultrasound for Neuraxial Block
Condition: Analgesia
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Rivanna Accuro US Device; Palpation; Neuraxial Analgesia; Spinal Block
Intervention type(s): Device; Other; Procedure; Procedure
Intervention description(s): 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.; 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.; Labor analgesia will be provided utilizing the standard medications to provide labor analgesia; Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There are 4 arms for this study--two are active comparators and two are experimental. The first arm is palpation with spinal block. The second arm is palpation with neuraxial block. The third arm is ultrasound with spinal block. The fourth arm is ultrasound with neuraxial block. Randomization is done twice - first for randomization of spinal block subjects between using palpation versus ultrasound method; and again randomization for neuraxial block (combined spinal epidural) subjects between using palpation versus ultrasound method. There will be a total of 120 planned evaluable subjects. This consists of planned evaluable randomized 60 subjects receiving spinal block for cesarean delivery (30 for palpation and 30 for ultrasound); and planned evaluable randomized 60 subjects receiving neuraxial (combined spinal epidural) block for labor analgesia.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: neuraxial analgesia; spinal block; epidural block