Rivanna Ultrasound for Neuraxial Block

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT03214640
• Collaborator: (none)
• Enrollment: 128
• Location: 1
• Arms: 4
• Actual Duration (Months): 17.6
• Patients Per Site Per Month: 7.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Analgesia	Device: Rivanna Accuro US Device; Other: Palpation; Procedure: Neuraxial Analgesia; Procedure: Spinal Block	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 128 participants
• 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.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
• Official Title: Evaluation of Success in Neuraxial Block Placement Between Using Palpation of Landmark Versus Pocket-Size Handheld Ultrasound (U/S) Method
• Actual Study Start Date: Oct 23, 2017
• Actual Primary Completion Date: Apr 13, 2019
• Actual Study Completion Date: Apr 13, 2019

Arms and Interventions

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	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.; Procedure: Spinal Block; Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care
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	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.; Procedure: Neuraxial Analgesia; Labor analgesia will be provided utilizing the standard medications to provide labor analgesia

Outcome Measures

Primary Outcome Measures

1. Time to Success of Neuraxial Block Placement [60-225 seconds]

   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.

Secondary Outcome Measures

1. Total Number of Needle Passes Per Placement [1 hour]

   Number of needle Passes before successful placement

2. Needle Passing Success at First Attempt [1 hour]

   Number of times of success (Number of patients) with first (single) attempt needle pass success

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novant Health Forsyth Medical Center	Winston-Salem	North Carolina	United States	27103

Sponsors and Collaborators

• Wake Forest University Health Sciences

Investigators

• Principal Investigator: Peter Pan, MD, MSEE, Professor, Anesthesiology

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 23, 2017
• Informed Consent Form - May 10, 2017

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT03214640
• Other Study ID Numbers: IRB00044968
• First Posted: Jul 11, 2017
• Last Update Posted: Jul 28, 2021
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Wake Forest University Health Sciences: neuraxial analgesia; spinal block; epidural block

Study Results

Participant Flow

Arm/Group Title	Palpation With Spinal Block (Group C-P)	Palpation With Neuraxial Block (Group L-P)	Rivanna Accuro Ultrasound Device With Spinal Block (Group C-R)	Rivanna Ultrasound Device With Neuraxial Block (Group L-R)
Arm/Group Description	insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest) for placement of spinal block for cesarean delivery Palpation description:: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Palpation method. 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.When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest). Those in group P, the neuraxial block will be performed as in the usual method using the needle insertion site identified with palpation. After placement of neuraxial labor analgesia the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not. Spinal Block: Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care	the needle insertion site for the neuraxial block will be identified with palpation for labor analgesia Palpation description:: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Palpation method. 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.When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest). Those in group P, the neuraxial block will be performed as in the usual method using the needle insertion site identified with palpation. After placement of neuraxial labor analgesia the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not. Neuraxial Analgesia: Labor analgesia will be provided utilizing the standard medications to provide labor analgesia	insertion will be identified with Rivanna Accuro U/S device for placement of spinal block for cesarean delivery 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. Spinal Block: Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care	insertion will be identified with Rivanna Accuro U/S device for placement of neuraxial block (combined spinal epidural) for labor analgesia 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. Neuraxial Analgesia: Labor analgesia will be provided utilizing the standard medications to provide labor analgesia
Period Title: Overall Study
STARTED	31	32	31	34
COMPLETED	30	30	30	30
NOT COMPLETED	1	2	1	4

Baseline Characteristics

Arm/Group Title	Palpation With Spinal Block (Group C-P)	Palpation With Neuraxial Block (Group L-P)	Rivanna Accuro Ultrasound Device With Spinal Block (Group C-R)	Rivanna Ultrasound Device With Neuraxial Block (Group L-R)	Total
Arm/Group Description	insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest) for placement of spinal block for cesarean delivery Palpation description:: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Palpation method. 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.When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest). Those in group P, the neuraxial block will be performed as in the usual method using the needle insertion site identified with palpation. After placement of neuraxial labor analgesia the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not. Spinal Block: Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care	the needle insertion site for the neuraxial block will be identified with palpation for labor analgesia Palpation description:: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Palpation method. 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.When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest). Those in group P, the neuraxial block will be performed as in the usual method using the needle insertion site identified with palpation. After placement of neuraxial labor analgesia the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not. Neuraxial Analgesia: Labor analgesia will be provided utilizing the standard medications to provide labor analgesia	insertion will be identified with Rivanna Accuro U/S device for placement of spinal block for cesarean delivery 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. Spinal Block: Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care	insertion will be identified with Rivanna Accuro U/S device for placement of neuraxial block (combined spinal epidural) for labor analgesia 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. Neuraxial Analgesia: Labor analgesia will be provided utilizing the standard medications to provide labor analgesia	Total of all reporting groups
Overall Participants	30	30	30	30	120
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.4 (5.8)	27.3 (5.3)	29.8 (4.8)	28.6 (6.4)	29.53 (5.6)
Sex/Gender, Customized (Count of Participants)
Female Subjects	30 100%	30 100%	30 100%	30 100%	120 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 3.3%	0 0%	0 0%	0 0%	1 0.8%
Asian	1 3.3%	0 0%	1 3.3%	0 0%	2 1.7%
Native Hawaiian or Other Pacific Islander	0 0%	1 3.3%	0 0%	0 0%	1 0.8%
Black or African American	8 26.7%	7 23.3%	5 16.7%	4 13.3%	24 20%
White	20 66.7%	22 73.3%	24 80%	26 86.7%	92 76.7%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	30 100%	30 100%	30 100%	30 100%	120 100%

Outcome Measures

1. Primary Outcome

Title	Time to Success of Neuraxial Block Placement
Description	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.
Time Frame	60-225 seconds

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Palpation With Spinal Block (Group C-P)	Palpation With Neuraxial Block (Group L-P)	Rivanna Accuro Ultrasound Device With Spinal Block (Group C-R)	Rivanna Ultrasound Device With Neuraxial Block (Group L-R)
Arm/Group Description	insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest) for placement of spinal block for cesarean delivery Palpation description:: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Palpation method. 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.When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest). Those in group P, the neuraxial block will be performed as in the usual method using the needle insertion site identified with palpation. After placement of neuraxial labor analgesia the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not. Spinal Block: Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care	the needle insertion site for the neuraxial block will be identified with palpation for labor analgesia Palpation description:: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Palpation method. 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.When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest). Those in group P, the neuraxial block will be performed as in the usual method using the needle insertion site identified with palpation. After placement of neuraxial labor analgesia the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not. Neuraxial Analgesia: Labor analgesia will be provided utilizing the standard medications to provide labor analgesia	insertion will be identified with Rivanna Accuro U/S device for placement of spinal block for cesarean delivery 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. Spinal Block: Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care	insertion will be identified with Rivanna Accuro U/S device for placement of neuraxial block (combined spinal epidural) for labor analgesia 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. Neuraxial Analgesia: Labor analgesia will be provided utilizing the standard medications to provide labor analgesia
Measure Participants	30	30	30	30
Median (Inter-Quartile Range) [seconds]	122	111	50	78.5

2. Secondary Outcome

Title	Total Number of Needle Passes Per Placement
Description	Number of needle Passes before successful placement
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Palpation With Spinal Block (Group C-P)	Palpation With Neuraxial Block (Group L-P)	Rivanna Accuro Ultrasound Device With Spinal Block (Group C-R)	Rivanna Ultrasound Device With Neuraxial Block (Group L-R)
Arm/Group Description	insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest) for placement of spinal block for cesarean delivery Palpation description:: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Palpation method. 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.When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest). Those in group P, the neuraxial block will be performed as in the usual method using the needle insertion site identified with palpation. After placement of neuraxial labor analgesia the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not. Spinal Block: Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care	the needle insertion site for the neuraxial block will be identified with palpation for labor analgesia Palpation description:: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Palpation method. 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.When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest). Those in group P, the neuraxial block will be performed as in the usual method using the needle insertion site identified with palpation. After placement of neuraxial labor analgesia the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not. Neuraxial Analgesia: Labor analgesia will be provided utilizing the standard medications to provide labor analgesia	insertion will be identified with Rivanna Accuro U/S device for placement of spinal block for cesarean delivery 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. Spinal Block: Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care	insertion will be identified with Rivanna Accuro U/S device for placement of neuraxial block (combined spinal epidural) for labor analgesia 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. Neuraxial Analgesia: Labor analgesia will be provided utilizing the standard medications to provide labor analgesia
Measure Participants	30	30	30	30
Median (Inter-Quartile Range) [number of needle passes needed to succes]	2	1	1	1

3. Secondary Outcome

Title	Needle Passing Success at First Attempt
Description	Number of times of success (Number of patients) with first (single) attempt needle pass success
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Palpation With Spinal Block (Group C-P)	Palpation With Neuraxial Block (Group L-P)	Rivanna Accuro Ultrasound Device With Spinal Block (Group C-R)	Rivanna Ultrasound Device With Neuraxial Block (Group L-R)
Arm/Group Description	insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest) for placement of spinal block for cesarean delivery Palpation description:: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Palpation method. 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.When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest). Those in group P, the neuraxial block will be performed as in the usual method using the needle insertion site identified with palpation. After placement of neuraxial labor analgesia the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not. Spinal Block: Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care	the needle insertion site for the neuraxial block will be identified with palpation for labor analgesia Palpation description:: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Palpation method. 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.When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest). Those in group P, the neuraxial block will be performed as in the usual method using the needle insertion site identified with palpation. After placement of neuraxial labor analgesia the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not. Neuraxial Analgesia: Labor analgesia will be provided utilizing the standard medications to provide labor analgesia	insertion will be identified with Rivanna Accuro U/S device for placement of spinal block for cesarean delivery 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. Spinal Block: Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care	insertion will be identified with Rivanna Accuro U/S device for placement of neuraxial block (combined spinal epidural) for labor analgesia 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. Neuraxial Analgesia: Labor analgesia will be provided utilizing the standard medications to provide labor analgesia
Measure Participants	30	30	30	30
Number [participants]	10 33.3%	18 60%	18 60%	24 80%

Adverse Events

Time Frame	Time frame of monitoring AEs and SAEs was from time of enrollment to 24 hours post delivery
Adverse Event Reporting Description	Study staff looked for postdural puncture headaches, neurological injury, or other serious events such as significant cv pul neurological and systemic complications. Study staff followed all Subjects the next day within 24 hours after delivery to make sure no untoward event no AR or SAEs.
Arm/Group Title	Palpation With Spinal Block (Group C-P)		Palpation With Neuraxial Block (Group L-P)		Rivanna Accuro Ultrasound Device With Spinal Block (Group C-R)		Rivanna Ultrasound Device With Neuraxial Block (Group L-R)
Arm/Group Description	insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest) for placement of spinal block for cesarean delivery Palpation description:: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Palpation method. 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.When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest). Those in group P, the neuraxial block will be performed as in the usual method using the needle insertion site identified with palpation. After placement of neuraxial labor analgesia the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not. Spinal Block: Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care		the needle insertion site for the neuraxial block will be identified with palpation for labor analgesia Palpation description:: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Palpation method. 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.When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest). Those in group P, the neuraxial block will be performed as in the usual method using the needle insertion site identified with palpation. After placement of neuraxial labor analgesia the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not. Neuraxial Analgesia: Labor analgesia will be provided utilizing the standard medications to provide labor analgesia		insertion will be identified with Rivanna Accuro U/S device for placement of spinal block for cesarean delivery 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. Spinal Block: Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care		insertion will be identified with Rivanna Accuro U/S device for placement of neuraxial block (combined spinal epidural) for labor analgesia 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. Neuraxial Analgesia: Labor analgesia will be provided utilizing the standard medications to provide labor analgesia
All Cause Mortality
	Palpation With Spinal Block (Group C-P)		Palpation With Neuraxial Block (Group L-P)		Rivanna Accuro Ultrasound Device With Spinal Block (Group C-R)		Rivanna Ultrasound Device With Neuraxial Block (Group L-R)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)		0/30 (0%)		0/30 (0%)
Serious Adverse Events
	Palpation With Spinal Block (Group C-P)		Palpation With Neuraxial Block (Group L-P)		Rivanna Accuro Ultrasound Device With Spinal Block (Group C-R)		Rivanna Ultrasound Device With Neuraxial Block (Group L-R)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)		0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Palpation With Spinal Block (Group C-P)		Palpation With Neuraxial Block (Group L-P)		Rivanna Accuro Ultrasound Device With Spinal Block (Group C-R)		Rivanna Ultrasound Device With Neuraxial Block (Group L-R)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)		0/30 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.