Health TrialsbyHealthPanel

Comparing PIEB and CEI for Labor Pain Relief

ConditionsLabor PainAnalgesia, EpiduralAnalgesia, ObstetricalLabor, Obstetric
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorDa Nang Family General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • PIEB + PCEA

    Procedure/Surgery

    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.

  • CEI + PCEA

    Procedure/Surgery

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: PIEB GroupExperimental treatment 1 intervention
Group B: CEI GroupActive comparator 1 intervention

Trial outcomes

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.

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 outcomes

1

Total Ropivacaine Consumption

The total dose of Ropivacaine (in milligrams) administered to each participant throughout the entire labor and delivery process. This sum includes the 10 mg initial manual bolus , the programmed intermittent boluses (8 mg/hour) or continuous infusion (8 mg/hour) , and any 5 mg patient-controlled epidural analgesia (PCEA) or manual rescue doses administered.

Time frame
From the initiation of epidural analgesia until the completion of perineal repair, assessed up to 24 hours.
2

Incidence of Maternal Motor Block

The presence and severity of motor blockade are evaluated using the Modified Bromage Scale (0 = No motor block; 1 = Inability to raise extended legs; 2 = Inability to flex knees; 3 = Inability to flex ankles). Higher scores mean a worse outcome (greater motor impairment).

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).
3

Maternal Satisfaction Score

Overall satisfaction is assessed using a 5-point Likert scale. The scale ranges from 1 to 5, where 1 indicates "Not Satisfied" and 5 indicates "Very Satisfied". Higher scores mean a better outcome (greater satisfaction).

Time frame
At 2 hours after the completion of perineal repair (assessed up to 24 hours after enrollment).
4

Neonatal Apgar Scores

Newborn health is assessed using the Apgar Scale. The total score ranges from 0 to 10, calculated based on five criteria (each scored 0-2). Higher scores mean a better outcome (better neonatal condition).

Time frame
At 1 minute and 5 minutes post-delivery.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Da Nang Family General Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now