Comparing the Quality of Labor Analgesia Between Modified Combined Spinal-Epidural and Dural Puncture Epidural Techniques: A Randomized Double Blinded Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 主要终点
- Comparison of the onset of effective analgesia between the study techniques
研究概览
简要总结
Epidural, Combined Spinal-Epidural, and more recently dural puncture epidural are forms of neuraxial anesthesia used to provide pain relief in laboring women . The investigators want to assess the onset of pain relief with 2 different neuraxial techniques performed at our center, but which have not yet been compared in the literature: (1) Modified CSE, with only local anesthetic injected into the spinal fluid to reduce side effects of opioids that are seen with the traditional CSE and (2) Dural Puncture Epidural (DPE), involving puncture of the spinal membrane, but without injection of medication into the spinal space. The investigators hypothesize that the onset of labor analgesia will be faster with modified CSE compared to DPE.
详细描述
Purpose of the research:
- To determine the onset of effective analgesia (Numerical Rating Scale (NRS) for pain </= 1/10 in minutes with the modified CSE and DPE techniques, which is our primary outcome.
- To assess block quality (time to T10 sensory block, motor block, asymmetric block, inadequate block) between the 2 techniques.
- To assess incidence of breakthrough pain as determined by number of physician interventions.
- To determine the incidence of side effects (maternal hypotension, pruritus, nausea, and fetal bradycardia).
- To assess delivery outcomes (vaginal vs. instrumental vs. CS).
- To compare fetal Apgar scores.
- To assess maternal satisfaction with pain relief using Likert scale at 24h.
- To evaluate for potential complications (Post-dural puncture headache, back pain, leg weakness, numbness and infection) related to the techniques at 24h.
Hypothesis:
The investigators hypothesize that the onset of effective analgesia (NRS pain </= 1, in minutes) will be faster with the modified CSE compared to DPE.
Methodology:
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
- Triple (Participant, Investigator, 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
- 是
入选标准
- •ASA II healthy adult parturients, at 37-40 weeks gestation with singleton pregnancy and vertex presentation.
- •Parturients in early labor with cervical dilatation less than 6 cm requesting epidural analgesia
- •Parturients able to provide written informed consent.
排除标准
- •Patient refusal to participate in the study.
- •Presence of clinically significant disease
- •Contraindications to neuraxial analgesia.
- •Presence of conditions associated with an increased risk of a cesarean delivery like history of uterine anomaly or surgery, morbid obesity and known fetal anomalies or non-reassuring fetal heart rate.
研究组 & 干预措施
Modified CSE
MCSE group: 1 ml of 0.25% bupivacaine will be injected intrathecally
干预措施: Modified CSE (Procedure)
Dural puncture epidural
Dural puncture performed with a spinal needle, but no medication will be injected intrathecally.
干预措施: Dural puncture epidural (Procedure)
结局指标
主要结局
Comparison of the onset of effective analgesia between the study techniques
时间窗: 1 year
Numerical Rating Scale (NRS) for pain \</= 1/10 in minutes
次要结局
- Comparison of the incidence of fetal bradycardia between the study techniques(1 year)
- Comparison of block quality between the study techniques(1 year)
- Comparison of the incidence of pruritus between the study techniques(1 year)