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Comparison of PIEB vs CEI for Labor Analgesia
The aim of this prospective, doubled-blinded randomized study is to compare two modes of epidural analgesia delivery, programmed intermittent epidural boluses (PIEB) versus continuous epidural infusion (CEI) with patient controlled epidural analgesia (PCEA) dosing, for providing labor epidural analgesia. The primary outcome will be the volume of local anesthetic received through PCEA. Secondary outcomes will measure time to first PCEA bolus, labor pain scores, degree of motor blockade, mode of delivery, PCEA attempts and ratio of successful to unsuccessful attempts, frequency of hypotension, duration of first and second stages of labor and level of patient satisfaction. The investigator plans to enroll 120 nulliparous participants at 2-5 com cervical dilation, with 60 patients to each arm. The subject will be assigned to receive either delivery of epidural medication ropivacaine 0.1% with fentanyl 2mcg/mL with PIEB + PCEA dosing method or CEI + PCEA. Continuous data will be analyzed using the Kruskal-Wallis test or t-test as appropriate. Categorical data will be analyzed using Chi-square test or Fisher's exact test as appropriate.
Details
| Lead sponsor | Duke University |
|---|---|
| Phase | PHASE4 |
| Status | COMPLETED |
| Enrolment | 179 |
| Start date | Tue Nov 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Wed Nov 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Labor Pain
Interventions
- Programmed Intermittent Epidural Bolus
- Continuous Epidural Infusion
- Ropivacaine
- Fentanyl
Countries
United States