Labor PainCOPILOTNCT07395934
Comparing PIEB and CEI for Labor Pain Relief
A study testing PIEB + PCEA and CEI + PCEA in people with Labor Pain and Analgesia, Epidural, run by Da Nang Family General Hospital at 1 site in Vietnam.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Labor Pain, Analgesia, Epidural, Analgesia, Obstetrical
- What is being tested?
- PIEB + PCEA and CEI + PCEA
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- 30 Jul 2025to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Family General Hospital
Da Nang, 50000
Thi Lan Phuong Nguyen, MD, MSc, +84375410293, lanphuongydh@gmail.com
Thi Lan Phuong Nguyen, MD, MSc
About this study
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
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.
Read the 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.
- Being tested
- PIEB + PCEA, CEI + PCEA
- Keywords
- Programmed Intermittent Epidural Bolus (PIEB), Continuous Epidural Infusion (CEI), Patient-Controlled Epidural Analgesia (PCEA), Visual Analog Scale (VAS)
- Medical subject headings
- Labor Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIEB + PCEAProcedure or 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 + PCEAProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| PIEB Group | Experimental | Maintenance of labor analgesia using Programmed Intermittent Epidural Bolus. Receives: Procedure: PIEB + PCEA |
| CEI Group | Active comparator | Maintenance of labor analgesia using Continuous Epidural Infusion. Receives: Procedure: CEI + PCEA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: From the initiation of epidural analgesia until the completion of perineal repair, assessed up to 24 hours.
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).
Measured: 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
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).
Measured: At 2 hours after the completion of perineal repair (assessed up to 24 hours after enrollment).
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).
Measured: At 1 minute and 5 minutes post-delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start30 Jul 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Da Nang Family General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395934
- Sponsor's protocol ID
- 02/2025/BVGD-HDĐĐ
- Acronym
- COPILOT
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07395934
- Acronym / sponsor ID
- COPILOT / 02/2025/BVGD-HDĐĐ
- Keywords
- Programmed Intermittent Epidural Bolus (PIEB), Continuous Epidural Infusion (CEI), Patient-Controlled Epidural Analgesia (PCEA), Visual Analog Scale (VAS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Da Nang Family General HospitalUniversity, hospital or other
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PIEB Group | Experimental | Procedure: PIEB + PCEAMaintenance of labor analgesia using Programmed Intermittent Epidural Bolus. |
| CEI Group | Active comparator | Procedure: CEI + PCEAMaintenance of labor analgesia using Continuous Epidural Infusion. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PIEB + PCEAInitial 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 or surgery | PIEB Group |
| CEI + PCEAInitial dose: 10 mL (0.1% Ropivacaine + 2 mcg/mL Fentanyl). Maintenance: Continuous infusion at 8 mL/hour. PCEA: 5 mL bolus, 10-min lockout. | Procedure or surgery | CEI Group |
Primary outcome
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
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.
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PIEB + PCEA and CEI + PCEA in people with Labor Pain and Analgesia, Epidural, run by Da Nang Family General Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.