Trial Outcomes & Findings for Assessment of the Use of Ultrasound for Epidural Catheter Placement and Comparison With Palpation Technique (NCT NCT02271100)
NCT ID: NCT02271100
Last Updated: 2026-03-03
Results Overview
Percentage of participants with catheters placed below the L3 Vertebra
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
110 participants
Primary outcome timeframe
immediately post epidural catheter placement
Results posted on
2026-03-03
Participant Flow
Participant milestones
| Measure |
Palpation Guidance
placement of spinal or combined spinal epidural needle using palpation to guide entry position
palpation guidance: use of palpation for position estimation
|
Ultrasound Guidance
placement of spinal or combined spinal epidural using ultrasound to guide entry position
ultrasound guidance: use of ultrasound for entry position estimation
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
|
Overall Study
COMPLETED
|
51
|
49
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
| Measure |
Palpation Guidance
placement of spinal or combined spinal epidural needle using palpation to guide entry position
palpation guidance: use of palpation for position estimation
|
Ultrasound Guidance
placement of spinal or combined spinal epidural using ultrasound to guide entry position
ultrasound guidance: use of ultrasound for entry position estimation
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Physician Decision
|
2
|
4
|
Baseline Characteristics
Assessment of the Use of Ultrasound for Epidural Catheter Placement and Comparison With Palpation Technique
Baseline characteristics by cohort
| Measure |
Palpation Guidance
n=51 Participants
placement of spinal or combined spinal epidural needle using palpation to guide entry position
palpation guidance: use of palpation for position estimation
|
Ultrasound Guidance
n=49 Participants
placement of spinal or combined spinal epidural using ultrasound to guide entry position
ultrasound guidance: use of ultrasound for entry position estimation
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Age, Continuous
|
33.7 years
STANDARD_DEVIATION 5.2 • n=41 Participants
|
33.3 years
STANDARD_DEVIATION 4.9 • n=35 Participants
|
33.5 years
STANDARD_DEVIATION 5.0 • n=76 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=41 Participants
|
49 Participants
n=35 Participants
|
100 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
14 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=41 Participants
|
43 Participants
n=35 Participants
|
86 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
16 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
24 Participants
n=76 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=41 Participants
|
26 Participants
n=35 Participants
|
60 Participants
n=76 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Nulliparity
|
29 Participants
n=41 Participants
|
27 Participants
n=35 Participants
|
56 Participants
n=76 Participants
|
PRIMARY outcome
Timeframe: immediately post epidural catheter placementPercentage of participants with catheters placed below the L3 Vertebra
Outcome measures
| Measure |
Ultrasound Guidance
n=49 Participants
placement of spinal or combined spinal epidural using ultrasound to guide entry position
ultrasound guidance: use of ultrasound for entry position estimation
|
Palpation Guidance
n=51 Participants
placement of spinal or combined spinal epidural needle using palpation to guide entry position
palpation guidance: use of palpation for position estimation
|
|---|---|---|
|
Placement Below L3 Vertebra
|
49 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: During the procedureThe time in minutes for completion of the procedure measured from the start of the procedure defined as administration of the first medication until the epidural test dose was administered
Outcome measures
| Measure |
Ultrasound Guidance
n=49 Participants
placement of spinal or combined spinal epidural using ultrasound to guide entry position
ultrasound guidance: use of ultrasound for entry position estimation
|
Palpation Guidance
n=51 Participants
placement of spinal or combined spinal epidural needle using palpation to guide entry position
palpation guidance: use of palpation for position estimation
|
|---|---|---|
|
Time to Placement
|
162 seconds
Standard Deviation 121
|
173 seconds
Standard Deviation 185
|
SECONDARY outcome
Timeframe: immediately post epidural catheter placement up to 30 minutesRelief of labor pain defined by verbal pain score less than 4 after administration of medication; verbal pain score consisted of a scale from 0 to 10 with 0 representing no pain and 10 representing worst possible pain, with higher numbers representing greater pain felt by the patient
Outcome measures
| Measure |
Ultrasound Guidance
n=49 Participants
placement of spinal or combined spinal epidural using ultrasound to guide entry position
ultrasound guidance: use of ultrasound for entry position estimation
|
Palpation Guidance
n=51 Participants
placement of spinal or combined spinal epidural needle using palpation to guide entry position
palpation guidance: use of palpation for position estimation
|
|---|---|---|
|
Success of the Epidural Catheter Placement
|
49 Participants
|
51 Participants
|
Adverse Events
Palpation Guidance
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ultrasound Guidance
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