Comparison of PIEB vs CEI for Labor Analgesia

Completed · Phase 4

Conditions studied: Labor Pain

In brief

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.

Key facts

Study ID

NCT02949271

Run by

Duke University

People needed

179

Starts

2016-11-08

Expected to finish

2017-11-01

Last updated by the study team

2019-01-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• American Society of Anesthesiology (ASA) class 2 and 3 women
• Nulliparous
• Age > 18 yrs
• gestational age > 36 weeks
• singleton pregnancies
• vertex pregnancies
• spontaneous labor or scheduled induction of labor
• cervical dilatation 2-5 cm at time of epidural placement
• Pain score > 5

You may not qualify if…

• BMI > 50 kg/m2
• history of past or current intravenous drug or chronic opioid abuse
• chronic analgesic use
• allergy or contraindication to any study medications
• any maternal or fetal condition requiring planned assisted stage 2 delivery

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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