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.
COMPLETED
NA
128 participants
60-225 seconds
2021-07-28
Participant Flow
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
| 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
| 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 secondsTime 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
| 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 hourNumber of needle Passes before successful placement
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 hourNumber of times of success (Number of patients) with first (single) attempt needle pass success
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)
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)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place