Phase 4
N=179
Comparison of PIEB vs CEI for Labor Analgesia
Labor Pain
Bottom Line
View on ClinicalTrials.gov: NCT02949271 ↗Enrolled (actual)
179
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Volume of Local Anesthetic Received Through Patient Controlled Epidural Analgesia (PCEA) Per Hour — 4.03; 4.52 milliliters per hour — p=0.17
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Programmed Intermittent Epidural Bolus (Other); Continuous Epidural Infusion (Other); Ropivacaine (Drug); Fentanyl (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Duke University
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Volume of Local Anesthetic Received Through Patient Controlled Epidural Analgesia (PCEA) Per Hour |
4.03; 4.52 | 0.17 |
| SECONDARY Volume of Local Anesthetic Required Per Hour |
11.49; 12.38 | 0.18 |
| SECONDARY Time to First Patient Controlled Epidural Analgesia (PCEA) Bolus |
— | — |
| SECONDARY Maximum Reported Labor Pain Score |
3; 2 | 0.27 |
| SECONDARY Degree of Motor Blockade Measured as Lowest Recorded Modified Bromage Score |
37; 26; 9; 20; 4; 3 | 0.28 |
| SECONDARY Total Number of Subjects Experiencing Each Mode of Delivery |
41; 37; 5; 5; 15; 17 | 0.85 |
| SECONDARY Number of Patient Controlled Epidural Analgesia (PCEA) Attempts |
0.75; 0.63 | 0.53 |
| SECONDARY Ratio of Patient Controlled Epidural Analgesia (PCEA) Successful Attempts to Unsuccessful Attempts |
0.17; 0.12 | 0.03 sig |
| SECONDARY Number of Subjects Experiencing Hypotension Requiring Vasopressor Treatment |
8; 3 | 0.21 |
| SECONDARY Duration of Second Stage of Labor |
44; 63 | — |
| SECONDARY Number of Subjects Who Were Satisfied With Procedure |
35; 39; 9; 3 | 0.08 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02949271). 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.