Trial Outcomes & Findings for Rivanna Ultrasound for Neuraxial Block (NCT NCT03214640)

NCT ID: NCT03214640

Last Updated: 2021-07-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

128 participants

Primary outcome timeframe

60-225 seconds

Results posted on

2021-07-28

Participant Flow

Participant milestones

Participant milestones
Measure
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 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
Palpation With Neuraxial Block (Group L-P)
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
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 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
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 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
Overall Study
STARTED
31
32
31
34
Overall Study
COMPLETED
30
30
30
30
Overall Study
NOT COMPLETED
1
2
1
4

Reasons for withdrawal

Reasons for withdrawal
Measure
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 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
Palpation With Neuraxial Block (Group L-P)
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
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 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
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 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
Overall Study
Protocol Violation
1
2
1
4

Baseline Characteristics

Rivanna Ultrasound for Neuraxial Block

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Palpation With Spinal Block (Group C-P)
n=30 Participants
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
Palpation With Neuraxial Block (Group L-P)
n=30 Participants
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
Rivanna Accuro Ultrasound Device With Spinal Block (Group C-R)
n=30 Participants
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
Rivanna Ultrasound Device With Neuraxial Block (Group L-R)
n=30 Participants
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
n=120 Participants
Total of all reporting groups
Race (NIH/OMB)
Black or African American
8 Participants
n=5 Participants
7 Participants
n=7 Participants
5 Participants
n=5 Participants
4 Participants
n=4 Participants
24 Participants
n=21 Participants
Race (NIH/OMB)
White
20 Participants
n=5 Participants
22 Participants
n=7 Participants
24 Participants
n=5 Participants
26 Participants
n=4 Participants
92 Participants
n=21 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Region of Enrollment
United States
30 participants
n=5 Participants
30 participants
n=7 Participants
30 participants
n=5 Participants
30 participants
n=4 Participants
120 participants
n=21 Participants
Age, Continuous
32.4 years
STANDARD_DEVIATION 5.8 • n=5 Participants
27.3 years
STANDARD_DEVIATION 5.3 • n=7 Participants
29.8 years
STANDARD_DEVIATION 4.8 • n=5 Participants
28.6 years
STANDARD_DEVIATION 6.4 • n=4 Participants
29.53 years
STANDARD_DEVIATION 5.6 • n=21 Participants
Sex/Gender, Customized
Female Subjects
30 Participants
n=5 Participants
30 Participants
n=7 Participants
30 Participants
n=5 Participants
30 Participants
n=4 Participants
120 Participants
n=21 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
2 Participants
n=21 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Palpation With Spinal Block (Group C-P)
n=30 Participants
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
Palpation With Neuraxial Block (Group L-P)
n=30 Participants
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
Rivanna Accuro Ultrasound Device With Spinal Block (Group C-R)
n=30 Participants
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
Rivanna Ultrasound Device With Neuraxial Block (Group L-R)
n=30 Participants
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
Time to Success of Neuraxial Block Placement
122 seconds
Interval 60.0 to 225.0
111 seconds
Interval 72.7 to 211.0
50 seconds
Interval 26.0 to 106.0
78.5 seconds
Interval 48.7 to 115.5

SECONDARY outcome

Timeframe: 1 hour

Number of needle Passes before successful placement

Outcome measures

Outcome measures
Measure
Palpation With Spinal Block (Group C-P)
n=30 Participants
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
Palpation With Neuraxial Block (Group L-P)
n=30 Participants
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
Rivanna Accuro Ultrasound Device With Spinal Block (Group C-R)
n=30 Participants
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
Rivanna Ultrasound Device With Neuraxial Block (Group L-R)
n=30 Participants
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 Number of Needle Passes Per Placement
2 number of needle passes needed to succes
Interval 1.0 to 4.0
1 number of needle passes needed to succes
Interval 1.0 to 2.0
1 number of needle passes needed to succes
Interval 1.0 to 2.0
1 number of needle passes needed to succes
Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: 1 hour

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

Outcome measures

Outcome measures
Measure
Palpation With Spinal Block (Group C-P)
n=30 Participants
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
Palpation With Neuraxial Block (Group L-P)
n=30 Participants
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
Rivanna Accuro Ultrasound Device With Spinal Block (Group C-R)
n=30 Participants
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
Rivanna Ultrasound Device With Neuraxial Block (Group L-R)
n=30 Participants
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
Needle Passing Success at First Attempt
10 participants
18 participants
18 participants
24 participants

Adverse Events

Palpation With Spinal Block (Group C-P)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Palpation With Neuraxial Block (Group L-P)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Rivanna Accuro Ultrasound Device With Spinal Block (Group C-R)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Rivanna Ultrasound Device With Neuraxial Block (Group L-R)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Peter Pan, MD

Wake Forest Health Science

Phone: 336-716-1228

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place