Rivanna Ultrasound for Neuraxial Block

NCT03214640 | Completed Results DMC FDA Device

• 1 other identifier: IRB00044968
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

neuraxial analgesia; spinal block; epidural block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Total Number of Needle Passes Per Placement

  1 hour

• Needle Passing Success at First Attempt

  1 hour

Study Arms (4)

Palpation with spinal block (Group C-P)

ACTIVE COMPARATOR

insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest) for placement of spinal block for cesarean delivery

Other: Palpation; Procedure: Spinal Block

Palpation with neuraxial block (Group L-P)

ACTIVE COMPARATOR

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; Procedure: Neuraxial Analgesia

Rivanna Accuro Ultrasound Device with spinal block (Group C-R)

EXPERIMENTAL

insertion will be identified with Rivanna Accuro U/S device for placement of spinal block for cesarean delivery

Device: Rivanna Accuro US Device; Procedure: Spinal Block

Rivanna Ultrasound Device with neuraxial block (Group L-R)

EXPERIMENTAL

insertion will be identified with Rivanna Accuro U/S device for placement of neuraxial block (combined spinal epidural) for labor analgesia

Device: Rivanna Accuro US Device; Procedure: Neuraxial Analgesia

Interventions

Rivanna Accuro US Device 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.

Rivanna Accuro Ultrasound Device with spinal block (Group C-R); Rivanna Ultrasound Device with neuraxial block (Group L-R)

Palpation OTHER

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.

Palpation with neuraxial block (Group L-P); Palpation with spinal block (Group C-P)

Neuraxial Analgesia PROCEDURE

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

Palpation with neuraxial block (Group L-P); Rivanna Ultrasound Device with neuraxial block (Group L-R)

Spinal Block PROCEDURE

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

Palpation with spinal block (Group C-P); Rivanna Accuro Ultrasound Device with spinal block (Group C-R)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Related Links

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

MeSH Terms

Conditions

Agnosia

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Peter Pan, MD
• Organization: Wake Forest Health Science

ppan@wakehealth.edu

336-716-1228

Study Officials

• Peter Pan, MD, MSEE

  Professor, Anesthesiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 11, 2017
• Study Start: October 23, 2017
• Primary Completion: April 13, 2019
• Study Completion: April 13, 2019
• Last Updated: July 28, 2021
• Results First Posted: July 28, 2021

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)