Trial Outcomes & Findings for 3D Ultrasound-guided Labor Epidural Analgesia in the Morbid Obese Parturient (NCT NCT03405311)
NCT ID: NCT03405311
Last Updated: 2026-02-17
Results Overview
An epidural insertion attempt will be defined as advancement of the needle in an effort to enter the epidural space; a needle requiring withdrawal for redirection or reinsertion through the skin/another skin puncture will be counted as an additional attempt.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Beginning of needle insertion till catheter placement-15 minutes
Results posted on
2026-02-17
Participant Flow
Participant milestones
| Measure |
Palpation
The control group (Group 2: Epidural) will receive the 'Blind/standard approach', which is the current standard of care using palpation in administering labor epidural analgesia. Additionally, an anesthesiologist will scan patient's back with Accuro device in turn off mode.
Palpation: The control group (Group 2: Epidural) will receive the 'Blind approach/palpation', which is using palpation in administering labor epidural analgesia. Additionally, anesthesiologist will scan patient's back with Accuro device in turned off mode
|
Rivanna Accuro 3D Ultrasound Device
The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device.
Rivanna Accuro 3D Ultrasound Device: The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
3D Ultrasound-guided Labor Epidural Analgesia in the Morbid Obese Parturient
Baseline characteristics by cohort
| Measure |
Palpation
n=20 Participants
The control group (Group 2: Epidural) will receive the 'Blind/standard approach', which is the current standard of care using palpation in administering labor epidural analgesia. Additionally, an anesthesiologist will scan patient's back with Accuro device in turn off mode.
Palpation: The control group (Group 2: Epidural) will receive the 'Blind approach/palpation', which is using palpation in administering labor epidural analgesia. Additionally, anesthesiologist will scan patient's back with Accuro device in turned off mode
|
Rivanna Accuro 3D Ultrasound Device
n=20 Participants
The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device.
Rivanna Accuro 3D Ultrasound Device: The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=25 Participants
|
20 Participants
n=20 Participants
|
40 Participants
n=45 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=25 Participants
|
20 Participants
n=20 Participants
|
40 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=25 Participants
|
8 Participants
n=20 Participants
|
16 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=25 Participants
|
11 Participants
n=20 Participants
|
21 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=25 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=45 Participants
|
PRIMARY outcome
Timeframe: Beginning of needle insertion till catheter placement-15 minutesAn epidural insertion attempt will be defined as advancement of the needle in an effort to enter the epidural space; a needle requiring withdrawal for redirection or reinsertion through the skin/another skin puncture will be counted as an additional attempt.
Outcome measures
| Measure |
Palpation
n=20 Participants
The control group (Group 2: Epidural) will receive the 'Blind/standard approach', which is the current standard of care using palpation in administering labor epidural analgesia. Additionally, an anesthesiologist will scan patient's back with Accuro device in turn off mode.
Palpation: The control group (Group 2: Epidural) will receive the 'Blind approach/palpation', which is using palpation in administering labor epidural analgesia. Additionally, anesthesiologist will scan patient's back with Accuro device in turned off mode
|
Rivanna Accuro 3D Ultrasound Device
n=20 Participants
The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device.
Rivanna Accuro 3D Ultrasound Device: The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device
|
|---|---|---|
|
Number of Needle Insertion Attempts Calculated Across All Participants
|
2 number of attempts
|
2 number of attempts
|
PRIMARY outcome
Timeframe: Within first 90 minutes following catheter placementNumber of Participants With Successful Epidural Catheter Placements.
Outcome measures
| Measure |
Palpation
n=20 Participants
The control group (Group 2: Epidural) will receive the 'Blind/standard approach', which is the current standard of care using palpation in administering labor epidural analgesia. Additionally, an anesthesiologist will scan patient's back with Accuro device in turn off mode.
Palpation: The control group (Group 2: Epidural) will receive the 'Blind approach/palpation', which is using palpation in administering labor epidural analgesia. Additionally, anesthesiologist will scan patient's back with Accuro device in turned off mode
|
Rivanna Accuro 3D Ultrasound Device
n=20 Participants
The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device.
Rivanna Accuro 3D Ultrasound Device: The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device
|
|---|---|---|
|
Number of Participants With Successful Epidural Catheter Placements
|
20 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: Beginning of needle insertion till catheter placement-15 minutesAn epidural insertion attempt will be defined as advancement of the needle in an effort to enter the epidural space; a needle requiring withdrawal for redirection or reinsertion through the skin/another skin puncture will be counted as an additional attempt.
Outcome measures
| Measure |
Palpation
n=20 Participants
The control group (Group 2: Epidural) will receive the 'Blind/standard approach', which is the current standard of care using palpation in administering labor epidural analgesia. Additionally, an anesthesiologist will scan patient's back with Accuro device in turn off mode.
Palpation: The control group (Group 2: Epidural) will receive the 'Blind approach/palpation', which is using palpation in administering labor epidural analgesia. Additionally, anesthesiologist will scan patient's back with Accuro device in turned off mode
|
Rivanna Accuro 3D Ultrasound Device
n=20 Participants
The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device.
Rivanna Accuro 3D Ultrasound Device: The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device
|
|---|---|---|
|
Number of Needle Insertion Redirections Calculated Across All Participants
|
2 number of redirections
|
2 number of redirections
|
SECONDARY outcome
Timeframe: Beginning of needle insertion till catheter placement-15 minutesProcedural difficulty will be rated by the performing anesthesiologist on a 10-point Likert scale from one (easy) to ten (extremely difficult).
Outcome measures
| Measure |
Palpation
n=20 Participants
The control group (Group 2: Epidural) will receive the 'Blind/standard approach', which is the current standard of care using palpation in administering labor epidural analgesia. Additionally, an anesthesiologist will scan patient's back with Accuro device in turn off mode.
Palpation: The control group (Group 2: Epidural) will receive the 'Blind approach/palpation', which is using palpation in administering labor epidural analgesia. Additionally, anesthesiologist will scan patient's back with Accuro device in turned off mode
|
Rivanna Accuro 3D Ultrasound Device
n=20 Participants
The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device.
Rivanna Accuro 3D Ultrasound Device: The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device
|
|---|---|---|
|
Procedural Difficulty Rated by the Performing Anesthesiologist on a 10-point Likert Scale
|
3 score on a scale
Interval 1.0 to 10.0
|
3 score on a scale
Interval 1.0 to 10.0
|
SECONDARY outcome
Timeframe: Beginning of needle insertion till catheter placement-15 minutesWe will also record thouy needle depth from skin and measured depth by ultrasound.
Outcome measures
| Measure |
Palpation
n=20 Participants
The control group (Group 2: Epidural) will receive the 'Blind/standard approach', which is the current standard of care using palpation in administering labor epidural analgesia. Additionally, an anesthesiologist will scan patient's back with Accuro device in turn off mode.
Palpation: The control group (Group 2: Epidural) will receive the 'Blind approach/palpation', which is using palpation in administering labor epidural analgesia. Additionally, anesthesiologist will scan patient's back with Accuro device in turned off mode
|
Rivanna Accuro 3D Ultrasound Device
n=20 Participants
The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device.
Rivanna Accuro 3D Ultrasound Device: The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device
|
|---|---|---|
|
Needle Depth
|
7.2 cm
Standard Deviation 1.3
|
7.2 cm
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Before epidural placementPressure pain thresholds will be obtained immediately prior to the epidural placement using the pressure pain device.
Outcome measures
| Measure |
Palpation
n=20 Participants
The control group (Group 2: Epidural) will receive the 'Blind/standard approach', which is the current standard of care using palpation in administering labor epidural analgesia. Additionally, an anesthesiologist will scan patient's back with Accuro device in turn off mode.
Palpation: The control group (Group 2: Epidural) will receive the 'Blind approach/palpation', which is using palpation in administering labor epidural analgesia. Additionally, anesthesiologist will scan patient's back with Accuro device in turned off mode
|
Rivanna Accuro 3D Ultrasound Device
n=20 Participants
The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device.
Rivanna Accuro 3D Ultrasound Device: The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device
|
|---|---|---|
|
Pressure Pain Thresholds
|
48 Newtons
Standard Deviation 19
|
45 Newtons
Standard Deviation 19
|
SECONDARY outcome
Timeframe: Within 30 days of admissionThe number of complications related to the epidural recorded within 30 days of admission.
Outcome measures
| Measure |
Palpation
n=20 Participants
The control group (Group 2: Epidural) will receive the 'Blind/standard approach', which is the current standard of care using palpation in administering labor epidural analgesia. Additionally, an anesthesiologist will scan patient's back with Accuro device in turn off mode.
Palpation: The control group (Group 2: Epidural) will receive the 'Blind approach/palpation', which is using palpation in administering labor epidural analgesia. Additionally, anesthesiologist will scan patient's back with Accuro device in turned off mode
|
Rivanna Accuro 3D Ultrasound Device
n=20 Participants
The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device.
Rivanna Accuro 3D Ultrasound Device: The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device
|
|---|---|---|
|
Number of Complications Recorded Calculated Across All Participants
|
0 number of complications
|
0 number of complications
|
Adverse Events
Palpation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rivanna Accuro 3D Ultrasound Device
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
Dr. Rovnat Babazade
University of Texas Medical Branch, Galveston
Phone: (409)772-1011
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place