Comparing PIEB and CEI for Labor Pain Relief

NCT07395934 | Recruiting

• 1 other identifier: 02/2025/BVGD-HDĐĐ
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized controlled trial is to compare the efficacy and safety of two epidural analgesia maintenance methods for labor pain relief: Programmed Intermittent Epidural Bolus (PIEB) and Continuous Epidural Infusion (CEI), both combined with Patient-Controlled Epidural Analgesia (PCEA). The study aims to evaluate which technique provides superior analgesia while minimizing anesthetic consumption and preserving maternal motor function. A total of 60 parturients at Family Hospital, Da Nang, will be randomly assigned to either the PIEB or CEI group. Outcomes including pain intensity (VAS scores), total drug consumption, maternal satisfaction, and neonatal Apgar scores will be assessed.

Conditions

Labor Pain; Analgesia, Epidural; Analgesia, Obstetrical; Labor, Obstetric

Keywords

Programmed Intermittent Epidural Bolus (PIEB); Continuous Epidural Infusion (CEI); Patient-Controlled Epidural Analgesia (PCEA); Visual Analog Scale (VAS)

Outcome Measures

Primary Outcomes (1)

• Labor Pain Intensity

  Pain intensity is assessed using the Visual Analog Scale (VAS), a self-reported scale where 0 represents "no pain" and 10 represents "the worst pain imaginable". Lower scores indicate better analgesic efficacy. Score on a scale from 0 to 10.

  Baseline (prior to epidural analgesia induction), then at 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, and 4 hours after the initiation of analgesia. Additional assessments are performed at full cervical dilation, during the fetal expulsion stage

Secondary Outcomes (4)

• Total Ropivacaine Consumption

  From the initiation of epidural analgesia until the completion of perineal repair, assessed up to 24 hours.

• Incidence of Maternal Motor Block

  From the initiation of epidural analgesia, assessed at 5, 10, 30, 60 minutes, then every 2 hours until the completion of perineal repair (assessed up to 24 hours).

• Maternal Satisfaction Score

  At 2 hours after the completion of perineal repair (assessed up to 24 hours after enrollment).

• Neonatal Apgar Scores

  At 1 minute and 5 minutes post-delivery.

Study Arms (2)

PIEB Group

EXPERIMENTAL

Maintenance of labor analgesia using Programmed Intermittent Epidural Bolus.

Procedure: PIEB + PCEA

CEI Group

ACTIVE COMPARATOR

Maintenance of labor analgesia using Continuous Epidural Infusion.

Procedure: CEI + PCEA

Interventions

PIEB + PCEA PROCEDURE

Initial dose: 10 mL (0.1% Ropivacaine + 2 mcg/mL Fentanyl). Maintenance: 8 mL bolus every 60 mins. PCEA: 5 mL bolus, 10-min lockout.

PIEB Group

CEI + PCEA PROCEDURE

Initial dose: 10 mL (0.1% Ropivacaine + 2 mcg/mL Fentanyl). Maintenance: Continuous infusion at 8 mL/hour. PCEA: 5 mL bolus, 10-min lockout.

CEI Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Da Nang Family General Hospital: lead

Study Sites (1)

Family General Hospital

Da Nang, 50000, Vietnam

RECRUITING

MeSH Terms

Conditions

Labor Pain; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: February 9, 2026
• Study Start: July 30, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-01

Locations

VN (1)