Rivanna Ultrasound for Neuraxial Block

Evaluation of Success in Neuraxial Block Placement Between Using Palpation of Landmark Versus Pocket-Size Handheld Ultrasound (U/S) Method

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.

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Other: Palpation; Procedure: Spinal Block; Procedure: Neuraxial Analgesia; Device: Rivanna Accuro US Device

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.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health Forsyth Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• BMI >30
• Female requesting analgesia for delivery, be it via vaginal or cesarean delivery

Exclusion Criteria:

• Allergy to ultrasound gel
• Contraindication to receiving neuraxial analgesia
• Under the age of 18

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Palpation with spinal block (Group C-P); insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest) for placement of spinal block for cesarean delivery	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: Spinal Block; Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care
Active Comparator: Palpation with neuraxial block (Group L-P); the needle insertion site for the neuraxial block will be identified with palpation for labor analgesia, using the spinous process and iliac crest for reference	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
Experimental: Rivanna Accuro Ultrasound Device with spinal block (Group C-R); insertion will be identified with Rivanna Accuro U/S device for placement of spinal block for cesarean delivery	Procedure: Spinal Block; Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care; 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.
Experimental: Rivanna Ultrasound Device with neuraxial block (Group L-R); insertion will be identified with Rivanna Accuro U/S device for placement of neuraxial block (combined spinal epidural) for labor analgesia	Procedure: Neuraxial Analgesia; Labor analgesia will be provided utilizing the standard medications to provide labor analgesia; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Success of Neuraxial Block Placement	Time it takes to successfully identify the epidural space (defined by loss of resistance) for the groups of subjects receiving labor neuraxial analgesia; and spinal fluid flow into the hub of spinal needle for the groups of subjects receiving cesarean spinal anesthetic - length of time (in minutes) it takes to get block placed, between palpation and ultrasound groups among patients with labor neuraxial analgesia patients and cesarean spinal anesthetic, respectively and spinal fluid flow with spinal needle - length of time (in seconds) it takes to get block placed, between the 2 groups.	60-225 seconds

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of Needle Passes Per Placement	Number of needle Passes before successful placement	1 hour
Needle Passing Success at First Attempt	Number of times of success (Number of patients) with first (single) attempt needle pass success	1 hour

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Peter Pan, MD, MSEE, Professor, Anesthesiology

Publications and helpful links

Helpful Links

• 510(k) clearance for the Rivanna Accuro handheld ultrasound device

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2017
• Primary Completion (Actual): April 13, 2019
• Study Completion (Actual): April 13, 2019

Study Registration Dates

• First Submitted: July 6, 2017
• First Submitted That Met QC Criteria: July 7, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 7, 2021
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: neuraxial analgesia; spinal block; epidural block
• Other Study ID Numbers: IRB00044968

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No