A Randomized Prospective Trial Comparing Dural Puncture Epidural (DPE) and Standard Epidural Analgesia for Labor in Term Pregnant Women"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Time to Onset of Effective Analgesia (VAS < 3)
研究概览
简要总结
This randomized prospective study compares Dural Puncture Epidural (DPE) and Standard Epidural Analgesia in term laboring women. The study evaluates analgesic quality, onset time, maternal and neonatal outcomes, side effects, and overall patient satisfaction.
详细描述
This prospective randomized clinical trial is designed to compare the efficacy and safety of Dural Puncture Epidural (DPE) analgesia with Standard Epidural Analgesia in term laboring women requesting neuraxial analgesia. The DPE technique involves performing a dural puncture with a 27-gauge Whitacre spinal needle through the Tuohy epidural needle before catheter placement, without administering any intrathecal medication. In both groups, a bolus of 10 mL 0.125% bupivacaine with 1.5 µg/mL fentanyl is administered following a negative epidural test dose.
The primary objective of the study is to determine whether DPE provides a faster onset and higher quality of labor analgesia compared with the conventional epidural technique. Secondary objectives include evaluating maternal hemodynamic changes, sensory and motor block characteristics, the need for additional bolus doses, total local anesthetic consumption, maternal side effects (hypotension, nausea, vomiting, pruritus, urinary retention), post-dural puncture headache, fetal heart rate changes, Apgar scores, duration of labor, and overall patient satisfaction.
Term pregnant women aged 18-45 years with cervical dilation ≥4 cm, effacement ≥50-60%, and baseline VAS ≥3 will be included. Exclusion criteria include hypertensive disorders of pregnancy, placental abnormalities, contraindications to neuraxial anesthesia, morbid obesity (BMI ≥40), drug allergy, opioid dependence, or accidental dural puncture with the epidural needle. Eligible participants will be randomly assigned to either the DPE group or the Standard Epidural group in a 1:1 ratio. All procedures will be performed at the Gazi Yaşargil Training and Research Hospital by anesthesiologists experienced in obstetric neuraxial techniques, and data will be collected by an independent observer not involved in the block procedure.
The study aims to contribute to the growing body of evidence on optimizing labor analgesia techniques by determining whether the DPE approach leads to improved analgesic effectiveness, greater maternal comfort, and stable maternal-fetal outcomes compared with standard epidural analgesia.
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
- None
盲法说明
This is an open-label study. Due to the nature of the neuraxial procedures, the anesthesiologist performing the block cannot be blinded to the intervention. Participants and clinical staff are also aware of the assigned technique. No masking was applied.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Term pregnant women (≥37 weeks of gestation).
- •Requesting neuraxial labor analgesia.
- •Age between 18 and 45 years.
- •ASA physical status I-II.
- •Cervical dilation ≥ 4 cm at the time of enrollment.
- •Cervical effacement ≥ 50-60%.
- •Baseline pain score of VAS ≥
- •Ability to provide informed consent.
排除标准
- •Hypertensive disorders of pregnancy (gestational hypertension, preeclampsia, eclampsia).
- •Placental abnormalities (placenta previa, placental abruption, etc.).
- •Contraindications to neuraxial anesthesia (coagulopathy, infection at puncture site, severe hypovolemia).
- •Known allergy or hypersensitivity to local anesthetics or opioids used in the study.
- •Morbid obesity (Body Mass Index ≥ 40 kg/m²).
- •Opioid dependence or chronic opioid use.
- •Accidental dural puncture with the epidural needle prior to randomization.
- •Multiple gestation or non-cephalic presentation (if clinically relevant to your protocol).
- •Fetal distress at the time of enrollment.
- •Patient refusal to participate.
- •Any condition deemed by the investigator to pose increased risk or interfere with study outcomes.
结局指标
主要结局
Time to Onset of Effective Analgesia (VAS < 3)
时间窗: Within 30 minutes after epidural bolus
Time in minutes from the administration of the initial epidural bolus until the patient reports a pain score of VAS \< 3, indicating effective labor analgesia.
次要结局
- Sensory Block Level(Within 30 minutes after epidural bolus)
- Motor Block Score (Bromage Score)(Within 30 minutes after epidural bolus)
- Need for Additional Epidural Bolus(During labor until delivery)
- Time to First Additional Bolus(From initiation of analgesia to delivery)
- Maternal Hemodynamic Changes(First 30 minutes after epidural bolus)
- Maternal Side Effects(During labor until delivery)
- Post-Dural Puncture Headache (PDPH)(Day 3 and Day 7 postpartum)
- Fetal Heart Rate Changes(During labor until delivery)
- Duration of Labor(From initiation of analgesia to delivery)
- Neonatal Apgar Scores(At 1 minute and 5 minutes after birth)
- Maternal Satisfaction Score(Immediately after delivery)
研究者
Mehmet Baran
Clinical Investigator
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital