Phase 4
N=101
Comparing Effectiveness of CSE Versus DPE for Labor Analgesia
Labor Pain
Bottom Line
View on ClinicalTrials.gov: NCT05068661 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Number of Participants With the Presence of Any of the Five Block Quality Components (or More Than One) — 16; 13 Participants — p=0.486
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ropivacaine 0.1% Injectable Solution (Drug); Bupivacaine 0.25% Injectable Solution (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Duke University
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With the Presence of Any of the Five Block Quality Components (or More Than One) |
16; 13 | 0.486 |
| SECONDARY Maternal Adverse Events |
40; 37 | 0.148 |
| SECONDARY Number of Participants With Motor Block as Measured by the Modified Bromage Score |
13; 10 | >0.999 |
| SECONDARY Duration of the Second Stage of Labor |
23; 47 | 0.128 |
| SECONDARY Total Labor Epidural Time |
443; 534 | >0.999 |
| SECONDARY Total Anesthetic Dose Required |
108; 108 | >0.999 |
| SECONDARY Number of Participants Who Self-administered PCEA (Patient-controlled Epidural Analgesia) Boluses |
40; 41 | >0.999 |
| SECONDARY Mode of Delivery |
32; 33; 2; 1; 1; 0 | >0.999 |
| SECONDARY Postpartum: Satisfaction With Analgesia Overall |
10; 10 | >0.999 |
Summary
The primary purpose of this study is to determine if there are differences in block quality between the CSE and DPE techniques for labor analgesia in parturients in active labor. We hypothesize that when compared to the CSE technique, the DPE technique will significantly improve block quality in this population and require fewer "top-ups" and catheter replacements.
Eligibility Criteria
Inclusion Criteria
- Ages 18-45, singleton, vertex fetuses at 37-41 weeks' gestation, nulliparous and multiparous women, cervical dilation of 2-7cm, pain score > 4, and English-speaking ability
Exclusion Criteria
- Women with major cardiac disease, chronic pain, chronic opioid use
Data sourced from ClinicalTrials.gov (NCT05068661). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.