Actively Recruiting
Comparison of Continuous Epidural Infusion vs. Programmed Intermittent Epidural Bolus Combined With Patient-Controlled Epidural Analgesia for Labor Pain Relief: A Randomized Controlled Trial
Led by Da Nang Family General Hospital · Updated on 2026-02-09
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two methods of epidural analgesia for relieving labor pain: Programmed Intermittent Epidural Bolus (PIEB) and Continuous Epidural Infusion (CEI), both combined with Patient-Controlled Epidural Analgesia (PCEA). This randomized controlled trial aims to compare how well each method controls pain while reducing anesthetic use and preserving maternal motor function. Sixty women in labor at Family Hospital, Da Nang, will be randomly assigned to either the PIEB or CEI group, and outcomes like pain levels, drug consumption, maternal satisfaction, and newborn Apgar scores will be assessed. All participants receive an initial manual epidural dose of 10 mL containing 0.1% Ropivacaine and 2 mcg/mL Fentanyl to start analgesia. The PIEB group then receives automated 8 mL boluses every hour, while the CEI group gets a continuous infusion at 8 mL per hour. Both groups can self-administer 5 mL boluses via PCEA with a 10-minute lockout and a maximum of 20 mL per hour. If pain remains high after two PCEA demands, a 5 mL rescue bolus is given by the anesthesia team. Participants will be monitored for pain intensity at multiple time points up to 4 hours after analgesia starts and during labor stages. Researchers will also measure total anesthetic consumption, maternal motor block incidence, maternal satisfaction, and newborn Apgar scores. Monitoring continues until perineal repair is complete, with assessments up to 24 hours after enrollment. The trial is scheduled to start in July 2025 and end in August 2026.
CONDITIONS
Brief Title
Comparing PIEB and CEI for Labor Pain Relief
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female parturients indicated for labor analgesia for vaginal delivery via epidural anesthesia
- Age from 18 to 40 years
- Physical status ASA II
- Singleton pregnancy, full-term, vertex presentation in labor
- Indication for vaginal delivery
- No contraindications to epidural anesthesia
- Agreement to participate in the research and signed written informed consent
You will not qualify if you...
- Contraindications to epidural analgesia
- History of allergy to local anesthetics (Ropivacaine) or opioids (Fentanyl)
- High-risk pregnancies: Preeclampsia, placenta previa, placental abruption
- Fetal distress or fetal abnormalities
- Chronic use of analgesic drugs or neurological/psychiatric disorders
- Parturients who refuse to participate or request to withdraw from the research
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From epidural initiation until delivery and perineal repair (up to 24 hours)
Participants receive labor analgesia via epidural anesthesia using either programmed intermittent epidural bolus or continuous epidural infusion, combined with patient-controlled epidural analgesia (PCEA) for pain relief during labor.
Continuous monitoring during labor with assessments at multiple timepoints including baseline, 5, 10, 30 minutes, 1, 2, and 4 hours after analgesia initiation, and during labor stages
Trial Site Locations
Total: 1 location
1
Family General Hospital
Da Nang, Vietnam, 50000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here