Adults 18 to 42, female only, with Morbid Obesity or Labor Pain. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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 DeliveryPrimary· 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.
Group
Value
95% CI
Dural Puncture Epidural (DPE)
34
Standard Epidural (EPL)
32
Time to Pain ReliefSecondary· Data will be collected for the first 30 minutes of epidural placement to achieve target pain ≤ 1/10
Time 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.
Group
Value
95% CI
Dural Puncture Epidural (DPE)
12
9 – 18
Standard Epidural (EPL)
15
9 – 21
Degree of Motor Block as Measured by the Lowest Bromage ScoreSecondary· 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.
Group
Value
95% CI
Dural Puncture Epidural (DPE)
5
5 – 5
Standard Epidural (EPL)
5
5 – 5
Number of Participants With Maternal Adverse EventsSecondary· From time of randomization to time of 24 hours after baby delivery (estimated 72 hours)
Duration of Second Stage of LaborSecondary· 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.
Group
Value
95% CI
Dural Puncture Epidural (DPE)
0.6
0.16 – 1.16
Standard Epidural (EPL)
0.32
0.2 – 1.48
Total Labor Epidural TimeSecondary· Total anesthetic time from time of epidural placement until discontinuation (estimated 72 hours)
Total labor epidural time
Group
Value
95% CI
Dural Puncture Epidural (DPE)
10.76
4.6 – 18.61
Standard Epidural (EPL)
10.11
6.01 – 15.19
Total Anesthetic (Ropivacaine 0.1% + Fentanyl 2) Dose Required Per HourSecondary· 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.
Group
Value
95% CI
Dural Puncture Epidural (DPE)
10.48
8.54 – 14.26
Standard Epidural (EPL)
10.88
8.15 – 16.11
Mode of DeliverySecondary· From time of randomization to time of baby delivery (estimated 72 hours)
Spontaneous, assisted, or cesarean delivery
Group
Value
95% CI
Dural Puncture Epidural (DPE)
39
Standard Epidural (EPL)
40
Dural Puncture Epidural (DPE)
4
Standard Epidural (EPL)
3
Dural Puncture Epidural (DPE)
23
Standard Epidural (EPL)
23
Highest Recorded Pain RatingSecondary· 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.
Group
Value
95% CI
Dural Puncture Epidural (DPE)
0
0 – 4
Standard Epidural (EPL)
1
0 – 5
Satisfaction in Anesthetic Care - Likert ScaleSecondary· Postpartum day 1
Maternal satisfaction with anesthetic care on a Likert scale from 0 - 10, 0 being unsatisfied to 10 being completely satisfied.
Group
Value
95% CI
Dural Puncture Epidural (DPE)
10
8 – 10
Standard Epidural (EPL)
9
8 – 10
Adverse events — posted to ClinicalTrials.gov
Time frame: From time of randomization to time of 24 hours after baby delivery (estimated 72 hours).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The primary purpose of this study is to determine differences in block quality between the "dural-puncture epidural" (DPE) and standard epidural (EPL) techniques for labor analgesia in the morbidly obese patient. The investigators hypothesize that when compared to the standard EPL, the DPE technique will improve block quality .
Study participants will be randomized by computer-generated sequence to EPL or DPE arms, stratified by class of obesity (BMI 35-39.9 kg/m2, 40\< 50 kg/m2 and ≥ 50 kg/m2) and by parity (nulliparous versus multiparous). All patients will receive a neuraxial technique in the sitting position at L3/4 or L4/5 using loss of resistance to saline. In the DPE group, a 25-g Whitacre needle will be used to puncture the dura. In both groups, the epidural catheter will be threaded 5 cm in the epidural space with an initiation dose of 15 ml of ropivacaine 0.1% with fentanyl (2 mcg/ml) over 6 minutes as per standard practice. After the initial loading dose and epidural pump is started, the blinded investigator will enter the patient's room to start data collection (time 0). Data will be collected for the first 30 minutes of epidural placement at 3,6,9,12,15,18 21, and 30 minutes to detect the time to achieve target pain ≤ 1/10, then assessed at standardized times (ever 2 hour) until delivery. Breakthrough pain will be managed by a standardized protocol. Other data to be collected will include: catheter adjustments and replacements, physician top-ups, asymmetrical block, pain score, motor block, sensory level to ice, hypotension, total anesthetic dose required, and PCEA use.
The primary outcome of this study is block quality defined by a composite of five components: (1) asymmetric block after 30 minutes of initiation, (2) top-up interventions, (3) catheter adjustments (4) failed catheter requiring replacement, and (5) failed epidural requiring general anesthesia or replacement neuraxial anesthesia for emergency cesarean section. Secondary outcomes include time to numeric pain rating scale ≤1, maternal adverse events (hypotension, fetal bradycardia, PDPH), motor block, duration of second stage of labor, total labor epidural time, total anesthetic dose required, PCEA use, and mode of delivery.
There is no increased risk/safety issue with placing a dural puncture technique than with epidural for labor analgesia.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Duke University
Last refreshed: 1 June 2022
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