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Recruiting NCT07395934

Comparing PIEB and CEI for Labor Pain Relief

No phase Interventional Labor Pain Analgesia, Epidural Analgesia, Obstetrical Labor, Obstetric

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PIEB + PCEA, CEI + PCEA.
Who it may be relevant to
Registry conditions: Labor Pain, Analgesia, Epidural, Analgesia, Obstetrical, Labor, Obstetric. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Vietnam
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparison of Continuous Epidural Infusion vs. Programmed Intermittent Epidural Bolus Combined With Patient-Controlled Epidural Analgesia for Labor Pain Relief: A Randomized Controlled Trial

Overview

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.

Detailed description

This study is a prospective, randomized controlled trial conducted at the Labor and Delivery Unit of Family Hospital, Da Nang. The investigation focuses on the clinical advantages of automated high-pressure bolus delivery (PIEB) compared to constant low-pressure flow (CEI) in optimizing the spread of local anesthetics within the epidural space.

Clinical Procedures: All participants receive a standardized initial manual bolus of 10 mL (0.1% Ropivacaine and 2 mcg/mL Fentanyl) to establish a baseline sensory block. Following this induction, patients are managed according to their assigned study arm:

PIEB Group: Analgesia is maintained using a programmed pump set to deliver an automated bolus of 8 mL every 60 minutes, starting one hour after the initial dose.

CEI Group: Analgesia is maintained via a continuous infusion of the same anesthetic solution at a constant rate of 8 mL/hour.

Analgesia Management and Rescue Protocol: Both groups have access to PCEA, allowing for self-administered 5 mL boluses with a 10-minute lockout period, capped at a maximum of 20 mL per hour.

To ensure maternal comfort, a standardized rescue protocol is strictly followed: if the Visual Analog Scale (VAS) score remains \> 4 after two consecutive PCEA demands, a manual rescue bolus of 5 mL is administered by the anesthesia team.

Interventions

  • Procedure PIEB + PCEA
    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.
  • Procedure CEI + PCEA
    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.

Primary outcome measures

  • Labor Pain Intensity [Time frame: 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 outcome measures (4)
  • Total Ropivacaine Consumption [Time frame: From the initiation of epidural analgesia until the completion of perineal repair, assessed up to 24 hours.]
  • Incidence of Maternal Motor Block [Time frame: 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 [Time frame: At 2 hours after the completion of perineal repair (assessed up to 24 hours after enrollment).]
  • Neonatal Apgar Scores [Time frame: At 1 minute and 5 minutes post-delivery.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Vietnam · 1 center
  • Family General Hospital — Da Nang

Identifiers

NCT: NCT07395934 · 02/2025/BVGD-HDĐĐ

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗