Dural Puncture Epidural For Early Labor Analgesia: A Randomized Comparison Between 27- and 25-Gauge Pencil Point Spinal Needles.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Time to pain ≤ 1 on NRS (0-10)
研究概览
简要总结
The rationale behind the dural puncture epidural (DPE) technique lies in the fact that a dural perforation with a spinal needle purportedly creates a conduit for accelerated translocation of local anesthetics from the epidural to the subarachnoid space. When compared with conventional epidural block, it provides improved sacral block and onset of analgesia.
Despite the benefits associated, the supportive literature remains scarce. No trial has determined if similar results could be obtained with a smaller needle.
In this trial, DPE using 25- and 27-gauge (G) spinal needles are compared. The main outcome will be the time required to obtain a pain score ≤ 1 using a 0-10 numeric rating scale (NRS). The hypothesis is that that both needle sizes will result in similar onset times and therefore designing the current study as an equivalence trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •healthy pregnant woman
- •singleton and vertex presentation
- •37-42 weeks of gestational age
- •active labor with cervical dilation < 5cm
- •body mass index between 20 and 35 kg/m2
- •desired labor epidural analgesia
排除标准
- •adults who are unable to give their own consent
- •presence of any pregnancy-related disease (e.g., gestational hypertension, preeclampsia, gestational diabetes)
- •known fetal anomalies
- •increased risk of cesarean delivery (e.g., previous uterine rupture, previous cesarean delivery)
- •coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or partial prothrombin time ≥ 50)
- •renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
- •hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
- •allergy to LA
- •prior sacral or lumbar spine surgery
结局指标
主要结局
Time to pain ≤ 1 on NRS (0-10)
时间窗: Up to 30 minutes after local anesthetic injection
Time elapsed between the end of local anesthetic injection and achievement of pain ≤ 1 on the NRS (measured every 2 minutes)
次要结局
- Type of labor(At the time of delivery)
- Number of DPE attempts(1 hour)
- Obstetric history(At the time of recruitment)
- Incidence of accidental dural puncture(1 hour)
- Gestational age(42 weeks)
- Oxytocin dose(At the time of DPE)
- Bilateral S2 sacral root block(Up to 30 minutes after local anesthetic injection)
- Presence of motor block(Up to 30 minutes after local anesthetic injection)
- Type of delivery(Delivery)
- Intervertebral level of puncture(At the time of DPE)
- State of membrane(At the time of DPE)
- Tocolysis requirement(Up to 1 hour after DPE)
- Apgar scores(At 1 and 5 minutes after delivery)
- Epidural blood patch incidence(Up to 1 week of followup)
- Cervical dilation(At the time of DPE)
- Pre-DPE level of pain(Immediate before DPE)
- Amount of IV fluids(24 hours)
- Performance time(1 hour)
- Incidence of epidural catheter adjustment or replacement(After DPE up to delivery)
- DPE side effects(After DPE up to delivery)
- DPE complications(After DPE up to 7 days postpartum)
- Sensory block height(Up to 30 minutes after local anesthetic injection)
- Number of epidural top-ups during labor(After DPE up to delivery)
- Fetal-Uterine assessment(Before and up to 1 hour after DPE)
研究者
Felipe Contreras Godoy
Clinical Instructor, Department of Anesthesia
University of Chile