Trial Outcomes & Findings for Utility of Ultrasound in Identification of Midline and Placement of Epidural in Severely Obese Parturients (NCT NCT03100968)
NCT ID: NCT03100968
Last Updated: 2021-09-29
Results Overview
Comparing the time it takes for epidural placement in the palpation group vs. the ultrasound group. Measured in minutes from local anesthesia skin wheal to administration of the epidural test dose.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
Baseline up to 1 hour
Results posted on
2021-09-29
Participant Flow
Participant milestones
| Measure |
Palpation Group
The palpation group will have an epidural placed after manual palpation of the spine.
Palpation: Traditional epidural methods used for the identification of the midline using palpation prior to procedure
|
Ultrasound Group
The ultrasound group will have an epidural placed after identifying midline with the ultrasound.
Ultrasound: Lumbar spinal ultrasound performed for identification of the midline prior to procedure.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
|
Overall Study
COMPLETED
|
75
|
75
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Palpation Group
n=75 Participants
The palpation group will have an epidural placed after manual palpation of the spine.
Palpation: Traditional epidural methods used for the identification of the midline using palpation prior to procedure
|
Ultrasound Group
n=75 Participants
The ultrasound group will have an epidural placed after identifying midline with the ultrasound.
Ultrasound: Lumbar spinal ultrasound performed for identification of the midline prior to procedure.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=75 Participants
|
0 Participants
n=75 Participants
|
0 Participants
n=150 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
75 Participants
n=75 Participants
|
75 Participants
n=75 Participants
|
150 Participants
n=150 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=75 Participants
|
0 Participants
n=75 Participants
|
0 Participants
n=150 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=75 Participants
|
75 Participants
n=75 Participants
|
150 Participants
n=150 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=75 Participants
|
0 Participants
n=75 Participants
|
0 Participants
n=150 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
75 participants
n=75 Participants
|
75 participants
n=75 Participants
|
150 participants
n=150 Participants
|
|
Body Mass Index
|
44.4 kg/m^2
STANDARD_DEVIATION 6.9 • n=75 Participants
|
43.3 kg/m^2
STANDARD_DEVIATION 7.1 • n=75 Participants
|
43.8 kg/m^2
STANDARD_DEVIATION 7.0 • n=150 Participants
|
|
Height
|
163.9 Centimeters
STANDARD_DEVIATION 8.2 • n=75 Participants
|
164.2 Centimeters
STANDARD_DEVIATION 7.1 • n=75 Participants
|
164.1 Centimeters
STANDARD_DEVIATION 7.7 • n=150 Participants
|
|
Weight
|
119.5 Kilograms
STANDARD_DEVIATION 20.6 • n=75 Participants
|
116.8 Kilograms
STANDARD_DEVIATION 20.2 • n=75 Participants
|
118.1 Kilograms
STANDARD_DEVIATION 20.4 • n=150 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 1 hourComparing the time it takes for epidural placement in the palpation group vs. the ultrasound group. Measured in minutes from local anesthesia skin wheal to administration of the epidural test dose.
Outcome measures
| Measure |
Palpation Group
n=75 Participants
The palpation group will have an epidural placed after manual palpation of the spine.
Palpation: Traditional epidural methods used for the identification of the midline using palpation prior to procedure
|
Ultrasound Group
n=75 Participants
The ultrasound group will have an epidural placed after identifying midline with the ultrasound.
Ultrasound: Lumbar spinal ultrasound performed for identification of the midline prior to procedure.
|
|---|---|---|
|
Time for Epidural Placement
|
9.0 minutes
Standard Deviation 6.8
|
6.2 minutes
Standard Deviation 3.8
|
PRIMARY outcome
Timeframe: Baseline up to 1 hourOutcome measures
| Measure |
Palpation Group
n=75 Participants
The palpation group will have an epidural placed after manual palpation of the spine.
Palpation: Traditional epidural methods used for the identification of the midline using palpation prior to procedure
|
Ultrasound Group
n=75 Participants
The ultrasound group will have an epidural placed after identifying midline with the ultrasound.
Ultrasound: Lumbar spinal ultrasound performed for identification of the midline prior to procedure.
|
|---|---|---|
|
Number of Needle Passes
|
2.8 needle passes
Standard Deviation 2.0
|
2.1 needle passes
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: Baseline up to 1 hourOutcome measures
| Measure |
Palpation Group
n=75 Participants
The palpation group will have an epidural placed after manual palpation of the spine.
Palpation: Traditional epidural methods used for the identification of the midline using palpation prior to procedure
|
Ultrasound Group
n=75 Participants
The ultrasound group will have an epidural placed after identifying midline with the ultrasound.
Ultrasound: Lumbar spinal ultrasound performed for identification of the midline prior to procedure.
|
|---|---|---|
|
Total Time
|
9.5 Minutes
Standard Deviation 6.8
|
6.9 Minutes
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: Baseline up to 1 hourComparing the time it takes to locate midline of the back in the palpation group vs. the ultrasound group. Measured in minutes from the start of the identification process until completion of the midline identification process.
Outcome measures
| Measure |
Palpation Group
n=75 Participants
The palpation group will have an epidural placed after manual palpation of the spine.
Palpation: Traditional epidural methods used for the identification of the midline using palpation prior to procedure
|
Ultrasound Group
n=75 Participants
The ultrasound group will have an epidural placed after identifying midline with the ultrasound.
Ultrasound: Lumbar spinal ultrasound performed for identification of the midline prior to procedure.
|
|---|---|---|
|
Time to Identify Midline
|
30.9 seconds
Standard Deviation 16.3
|
44.5 seconds
Standard Deviation 24.7
|
SECONDARY outcome
Timeframe: Baseline up to 1 hourComparing the number of epidural failures in the palpation vs. ultrasound group.
Outcome measures
| Measure |
Palpation Group
n=75 Participants
The palpation group will have an epidural placed after manual palpation of the spine.
Palpation: Traditional epidural methods used for the identification of the midline using palpation prior to procedure
|
Ultrasound Group
n=75 Participants
The ultrasound group will have an epidural placed after identifying midline with the ultrasound.
Ultrasound: Lumbar spinal ultrasound performed for identification of the midline prior to procedure.
|
|---|---|---|
|
Epidural Failure Rate
|
7 failed epidurals
|
3 failed epidurals
|
SECONDARY outcome
Timeframe: Baseline up to 1 hourOutcome measures
| Measure |
Palpation Group
n=75 Participants
The palpation group will have an epidural placed after manual palpation of the spine.
Palpation: Traditional epidural methods used for the identification of the midline using palpation prior to procedure
|
Ultrasound Group
n=75 Participants
The ultrasound group will have an epidural placed after identifying midline with the ultrasound.
Ultrasound: Lumbar spinal ultrasound performed for identification of the midline prior to procedure.
|
|---|---|---|
|
Number of Top-offs Required
|
0.5 number of topoffs required
Standard Deviation 1.1
|
0.4 number of topoffs required
Standard Deviation 0.9
|
Adverse Events
Palpation Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ultrasound Group
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place