Comparison of Continuous Epidural Infusion vs. Programmed Intermittent Epidural Bolus Combined With Patient-Controlled Epidural Analgesia for Labor Pain Relief: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Labor Pain Intensity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
PIEB Group
Maintenance of labor analgesia using Programmed Intermittent Epidural Bolus.
干预措施: PIEB + PCEA (Procedure)
CEI Group
Maintenance of labor analgesia using Continuous Epidural Infusion.
干预措施: CEI + PCEA (Procedure)
结局指标
主要结局
Labor Pain Intensity
时间窗: 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.
次要结局
- 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.)