Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03074695 · ClinicalTrials.gov registry record · Phase 4
DPE Technique in Labor Epidural for Morbidly Obese Women
A Phase 4 study of Morbid Obesity and Labor Pain, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 141
- Enrollment target
- 1
- Study location
NCT03074695 is a Phase 4 study of Morbid Obesity and Labor Pain that has completed, run by Duke University. The registered enrollment target is 141 participants, above the 116-participant average among 24 other Morbid Obesity trials with a reported enrollment target (22% higher). The trial reports 1 study location across 1 state.
The verdict
NCT03074695, a Phase 4 study of Morbid Obesity and Labor Pain, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 141 participants
- Enrollment target
- 1
- Study location
Study Summary
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
Conditions Studied
Interventions
- PROCEDURE Dural puncture epidural (DPE)
- PROCEDURE Standard Epidural (EPL)
- DRUG Dural puncture epidural (DPE)
- DRUG Standard Epidural (EPL)
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2017-04-01 |
| Est. Completion | 2020-11-06 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03074695
The ClinicalTrials.gov registry entry for NCT03074695 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 141 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 116-participant average among 24 other Morbid Obesity trials with a reported enrollment target (22% higher). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Morbid Obesity appearing as the primary indexed condition, and to 4 interventions - of which Dural puncture epidural (DPE) is the first listed.
NCT03074695 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT03074695 about?
NCT03074695 is a clinical study titled "DPE Technique in Labor Epidural for Morbidly Obese Women". 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...
What is the current status of trial NCT03074695?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 141 participants. The study started on 2017-04-01. Estimated completion is 2020-11-06.
What conditions does trial NCT03074695 study?
This clinical trial studies the following conditions: Morbid Obesity, Labor Pain.
What interventions are being tested in trial NCT03074695?
The interventions under investigation include: Dural puncture epidural (DPE) (PROCEDURE), Standard Epidural (EPL) (PROCEDURE), Dural puncture epidural (DPE) (DRUG), Standard Epidural (EPL) (DRUG).
Who is sponsoring clinical trial NCT03074695?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03074695 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Morbid Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Impact GLP-1 Agonists Following Bariatric
RECRUITING · Phase 4
-
Induction of Labor in Morbidly Obese Patients
RECRUITING · Early Phase 1
-
Whole Transcriptome Profiling and Metabolic Phenotyping in Children With ROHHAD Syndrome
RECRUITING
-
Gut Microbiota in Metabolic Surgery
RECRUITING
-
Effect of Limb Length Ratio on Roux-en-Y Gastric Bypass Outcomes (CLIMB II Study)
RECRUITING · NA
-
Metabolic Responses to Bariatric Surgery
RECRUITING
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.