Trial Outcomes & Findings for DPE Technique in Labor Epidural for Morbidly Obese Women (NCT NCT03074695)
NCT ID: NCT03074695
Last Updated: 2022-06-01
Results Overview
Composite outcome: asymmetric block, top-up interventions required, catheter adjustments, replacement of epidural catheter, or failure or block requiring emergency general anesthesia or rescue neuraxial prior to cesarean delivery Values shared are indicative of the number of participants who have the one or more of the composite elements for the composite outcome.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
141 participants
Primary outcome timeframe
From time of randomization to time of delivery, assessed at standardized times (ever 2 hour) until delivery (estimated 72 hours).
Results posted on
2022-06-01
Participant Flow
Participant milestones
| Measure |
Dural Puncture Epidural (DPE)
Women who have analgesia initiated with a DPE technique
Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm cerebral spinal fluid (CSF) position. No intrathecal dosing
Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm CSF position. No intrathecal dosing. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
|
Standard Epidural (EPL)
Women who have analgesia initiated with an epidural technique
Standard Epidural (EPL): Standard epidural placement
Standard Epidural (EPL): Standard epidural placement. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
71
|
|
Overall Study
COMPLETED
|
66
|
66
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Dural Puncture Epidural (DPE)
Women who have analgesia initiated with a DPE technique
Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm cerebral spinal fluid (CSF) position. No intrathecal dosing
Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm CSF position. No intrathecal dosing. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
|
Standard Epidural (EPL)
Women who have analgesia initiated with an epidural technique
Standard Epidural (EPL): Standard epidural placement
Standard Epidural (EPL): Standard epidural placement. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
|
|---|---|---|
|
Overall Study
Delivered with caesarean before request for analgesia
|
1
|
1
|
|
Overall Study
Research staff not available
|
1
|
2
|
|
Overall Study
Did not receive neuraxial block
|
2
|
2
|
Baseline Characteristics
DPE Technique in Labor Epidural for Morbidly Obese Women
Baseline characteristics by cohort
| Measure |
Dural Puncture Epidural (DPE)
n=66 Participants
Women who have analgesia initiated with a DPE technique
Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm cerebral spinal fluid (CSF) position. No intrathecal dosing
Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm CSF position. No intrathecal dosing. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
|
Standard Epidural (EPL)
n=66 Participants
Women who have analgesia initiated with an epidural technique
Standard Epidural (EPL): Standard epidural placement
Standard Epidural (EPL): Standard epidural placement. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.0 years
n=5 Participants
|
30.0 years
n=7 Participants
|
30.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From time of randomization to time of delivery, assessed at standardized times (ever 2 hour) until delivery (estimated 72 hours).Composite outcome: asymmetric block, top-up interventions required, catheter adjustments, replacement of epidural catheter, or failure or block requiring emergency general anesthesia or rescue neuraxial prior to cesarean delivery Values shared are indicative of the number of participants who have the one or more of the composite elements for the composite outcome.
Outcome measures
| Measure |
Dural Puncture Epidural (DPE)
n=66 Participants
Women who have analgesia initiated with a DPE technique
Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm cerebral spinal fluid (CSF) position. No intrathecal dosing
Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm CSF position. No intrathecal dosing. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
|
Standard Epidural (EPL)
n=66 Participants
Women who have analgesia initiated with an epidural technique
Standard Epidural (EPL): Standard epidural placement
Standard Epidural (EPL): Standard epidural placement. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
|
|---|---|---|
|
Number of Participants Who Required Asymmetric Block, Top-up Interventions, Catheter Adjustments, Replacement of Epidural Catheter, or Failure of Block Requiring Emergency General Anesthesia or Rescue Neuraxial Prior to Cesarean Delivery
|
34 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Data will be collected for the first 30 minutes of epidural placement to achieve target pain ≤ 1/10Time in minutes to numeric pain relief scale \<= 1. Less time is better, as the pain relief scale is from 0 - 10, where 10 is the worst imaginable and 0 is no pain.
Outcome measures
| Measure |
Dural Puncture Epidural (DPE)
n=66 Participants
Women who have analgesia initiated with a DPE technique
Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm cerebral spinal fluid (CSF) position. No intrathecal dosing
Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm CSF position. No intrathecal dosing. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
|
Standard Epidural (EPL)
n=66 Participants
Women who have analgesia initiated with an epidural technique
Standard Epidural (EPL): Standard epidural placement
Standard Epidural (EPL): Standard epidural placement. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
|
|---|---|---|
|
Time to Pain Relief
|
12 minutes
Interval 9.0 to 18.0
|
15 minutes
Interval 9.0 to 21.0
|
SECONDARY outcome
Timeframe: From time of randomization to time of baby delivery (estimated 72 hours)The Bromage Score is used to measure degree of motor block, with a range of 1 to 5. A lower score indicates more motor block, so a higher value means a better outcome.
Outcome measures
| Measure |
Dural Puncture Epidural (DPE)
n=66 Participants
Women who have analgesia initiated with a DPE technique
Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm cerebral spinal fluid (CSF) position. No intrathecal dosing
Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm CSF position. No intrathecal dosing. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
|
Standard Epidural (EPL)
n=66 Participants
Women who have analgesia initiated with an epidural technique
Standard Epidural (EPL): Standard epidural placement
Standard Epidural (EPL): Standard epidural placement. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
|
|---|---|---|
|
Degree of Motor Block as Measured by the Lowest Bromage Score
|
5 score on a scale
Interval 5.0 to 5.0
|
5 score on a scale
Interval 5.0 to 5.0
|
SECONDARY outcome
Timeframe: From time of randomization to time of 24 hours after baby delivery (estimated 72 hours)Hypotension, fetal bradycardia, post-dural puncture headache
Outcome measures
| Measure |
Dural Puncture Epidural (DPE)
n=66 Participants
Women who have analgesia initiated with a DPE technique
Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm cerebral spinal fluid (CSF) position. No intrathecal dosing
Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm CSF position. No intrathecal dosing. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
|
Standard Epidural (EPL)
n=66 Participants
Women who have analgesia initiated with an epidural technique
Standard Epidural (EPL): Standard epidural placement
Standard Epidural (EPL): Standard epidural placement. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
|
|---|---|---|
|
Number of Participants With Maternal Adverse Events
Hypotension
|
2 Participants
|
6 Participants
|
|
Number of Participants With Maternal Adverse Events
Fetal Bradycardia
|
7 Participants
|
7 Participants
|
|
Number of Participants With Maternal Adverse Events
Post-dural Puncture Headache
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From time of randomization to time of baby delivery (estimated 72 hours)The second stage of labor begins when the cervix is completely dilated and ends with the delivery of the baby.
Outcome measures
| Measure |
Dural Puncture Epidural (DPE)
n=66 Participants
Women who have analgesia initiated with a DPE technique
Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm cerebral spinal fluid (CSF) position. No intrathecal dosing
Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm CSF position. No intrathecal dosing. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
|
Standard Epidural (EPL)
n=66 Participants
Women who have analgesia initiated with an epidural technique
Standard Epidural (EPL): Standard epidural placement
Standard Epidural (EPL): Standard epidural placement. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
|
|---|---|---|
|
Duration of Second Stage of Labor
|
0.6 hours
Interval 0.16 to 1.16
|
0.32 hours
Interval 0.2 to 1.48
|
SECONDARY outcome
Timeframe: Total anesthetic time from time of epidural placement until discontinuation (estimated 72 hours)Total labor epidural time
Outcome measures
| Measure |
Dural Puncture Epidural (DPE)
n=66 Participants
Women who have analgesia initiated with a DPE technique
Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm cerebral spinal fluid (CSF) position. No intrathecal dosing
Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm CSF position. No intrathecal dosing. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
|
Standard Epidural (EPL)
n=66 Participants
Women who have analgesia initiated with an epidural technique
Standard Epidural (EPL): Standard epidural placement
Standard Epidural (EPL): Standard epidural placement. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
|
|---|---|---|
|
Total Labor Epidural Time
|
10.76 hours
Interval 4.6 to 18.61
|
10.11 hours
Interval 6.01 to 15.19
|
SECONDARY outcome
Timeframe: From time of randomization to time of baby delivery (estimated 72 hours)Consumption of epidural medications in ml including physician boluses, programmed boluses and patient controlled boluses.
Outcome measures
| Measure |
Dural Puncture Epidural (DPE)
n=66 Participants
Women who have analgesia initiated with a DPE technique
Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm cerebral spinal fluid (CSF) position. No intrathecal dosing
Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm CSF position. No intrathecal dosing. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
|
Standard Epidural (EPL)
n=66 Participants
Women who have analgesia initiated with an epidural technique
Standard Epidural (EPL): Standard epidural placement
Standard Epidural (EPL): Standard epidural placement. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
|
|---|---|---|
|
Total Anesthetic (Ropivacaine 0.1% + Fentanyl 2) Dose Required Per Hour
|
10.48 mL/hour
Interval 8.54 to 14.26
|
10.88 mL/hour
Interval 8.15 to 16.11
|
SECONDARY outcome
Timeframe: From time of randomization to time of baby delivery (estimated 72 hours)Spontaneous, assisted, or cesarean delivery
Outcome measures
| Measure |
Dural Puncture Epidural (DPE)
n=66 Participants
Women who have analgesia initiated with a DPE technique
Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm cerebral spinal fluid (CSF) position. No intrathecal dosing
Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm CSF position. No intrathecal dosing. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
|
Standard Epidural (EPL)
n=66 Participants
Women who have analgesia initiated with an epidural technique
Standard Epidural (EPL): Standard epidural placement
Standard Epidural (EPL): Standard epidural placement. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
|
|---|---|---|
|
Mode of Delivery
Spontaneous
|
39 Participants
|
40 Participants
|
|
Mode of Delivery
Assisted
|
4 Participants
|
3 Participants
|
|
Mode of Delivery
Cesarean delivery
|
23 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: From time of randomization, every 2 hours until time of delivery (estimated 72 hours)Numeric pain rating scale (0-10), where higher values indicate more pain or larger change.
Outcome measures
| Measure |
Dural Puncture Epidural (DPE)
n=66 Participants
Women who have analgesia initiated with a DPE technique
Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm cerebral spinal fluid (CSF) position. No intrathecal dosing
Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm CSF position. No intrathecal dosing. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
|
Standard Epidural (EPL)
n=66 Participants
Women who have analgesia initiated with an epidural technique
Standard Epidural (EPL): Standard epidural placement
Standard Epidural (EPL): Standard epidural placement. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
|
|---|---|---|
|
Highest Recorded Pain Rating
|
0 score on a scale
Interval 0.0 to 4.0
|
1 score on a scale
Interval 0.0 to 5.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Postpartum day 1Maternal satisfaction with anesthetic care on a Likert scale from 0 - 10, 0 being unsatisfied to 10 being completely satisfied.
Outcome measures
| Measure |
Dural Puncture Epidural (DPE)
n=66 Participants
Women who have analgesia initiated with a DPE technique
Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm cerebral spinal fluid (CSF) position. No intrathecal dosing
Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm CSF position. No intrathecal dosing. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
|
Standard Epidural (EPL)
n=66 Participants
Women who have analgesia initiated with an epidural technique
Standard Epidural (EPL): Standard epidural placement
Standard Epidural (EPL): Standard epidural placement. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
|
|---|---|---|
|
Satisfaction in Anesthetic Care - Likert Scale
|
10 score on a scale
Interval 8.0 to 10.0
|
9 score on a scale
Interval 8.0 to 10.0
|
Adverse Events
Dural Puncture Epidural (DPE)
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Standard Epidural (EPL)
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dural Puncture Epidural (DPE)
n=66 participants at risk
Women who have analgesia initiated with a DPE technique
Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm cerebral spinal fluid (CSF) position. No intrathecal dosing
Dural puncture epidural (DPE): Epidural with spinal needle placed to confirm CSF position. No intrathecal dosing. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
|
Standard Epidural (EPL)
n=66 participants at risk
Women who have analgesia initiated with an epidural technique
Standard Epidural (EPL): Standard epidural placement
Standard Epidural (EPL): Standard epidural placement. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
|
|---|---|---|
|
Cardiac disorders
Hypotension
|
3.0%
2/66 • From time of randomization to time of 24 hours after baby delivery (estimated 72 hours)
|
9.1%
6/66 • From time of randomization to time of 24 hours after baby delivery (estimated 72 hours)
|
|
Pregnancy, puerperium and perinatal conditions
Fetal Bradycardia
|
10.6%
7/66 • From time of randomization to time of 24 hours after baby delivery (estimated 72 hours)
|
10.6%
7/66 • From time of randomization to time of 24 hours after baby delivery (estimated 72 hours)
|
|
Nervous system disorders
Post-dural Puncture Headache
|
0.00%
0/66 • From time of randomization to time of 24 hours after baby delivery (estimated 72 hours)
|
0.00%
0/66 • From time of randomization to time of 24 hours after baby delivery (estimated 72 hours)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
40.9%
27/66 • From time of randomization to time of 24 hours after baby delivery (estimated 72 hours)
|
37.9%
25/66 • From time of randomization to time of 24 hours after baby delivery (estimated 72 hours)
|
|
General disorders
Nausea
|
16.7%
11/66 • From time of randomization to time of 24 hours after baby delivery (estimated 72 hours)
|
16.7%
11/66 • From time of randomization to time of 24 hours after baby delivery (estimated 72 hours)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place