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临床试验/NCT03366935
NCT03366935已完成不适用

Combined Implementation of Dural Puncture Epidural Technique and Programmed Intermittent Epidural Bolus for Labor Analgesia

Shanghai First Maternity and Infant Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年10月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Compare time of onset of labor analgesia among the study groups

研究概览

简要总结

This study intends to carry out a prospective, randomized double-blind study to evaluate the safety and efficacy of the combined implementation of Dural puncture epidural (DPE) technique and Programmed intermittent epidural bolus (PIEB) for labor analgesia.

详细描述

Epidural (EPL) technique is the standard technique for labor analgesia, but can be associated with slow onset and inadequate sacral spread, unilateral or patchy sensory blockade, motor impairment. The combined spinal epidural (CSE) technique can provide rapid onset of analgesia, but is associated with greater side effects, including pruritus, fetal bradycardia and delayed testing of epidural catheters. Dural puncture epidural (DPE) technique is a modification of CSE technique. A spinal needle is introduced through the epidural needle to create a single dural puncture , after intrathecal space was identified by the free flow of cerebrospinal fluid (CSF) , the needle was removed without direct medication administration into the subarachnoid space. Privous studies have demonstrated that the DPE technique can improve block quality over the EPL technique with fewer maternal and fetal side effects than the CSE technique for parturients requesting labor analgesia. Besides the neuraxial techniques, maintenance regimens is another factor that affect the analgesic effect. Programmed intermittent epidural bolus (PIEB) provides greater spread of local anesthetic solution within the epidural space and therefore superior quality of analgesia compared with continuous epidural infusion (CEI). We designed this prospective randomized, double-blind study to evaluate the safety and efficacy of the combined implementation of DPE technique and PIEB for labor 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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women requeste labor analgesia
  • ASA I or II
  • at 37-42 weeks' gestation
  • nulliparous
  • singleton pregnancy, vertex presentation
  • visual Numerical Rating Scale (VNRS) at requesting analgesia > 5 (NRPS 0-10)
  • cervical dilatation < 5 cm

排除标准

  • patient refusal to participate in the study
  • age <20 years or >40 years
  • body mass Index(BMI)>50 (Kg/m2)
  • clinically significant diseases of pregnancy (i.e.,gestational hypertension, preeclampsia, gestational placenta previa, placental abruption diabetes)
  • contraindications to neuraxial analgesia
  • conditions associated with an increased risk of a cesarean delivery (i.e., history of uterine anomaly or surgery, morbid obesity) and known anomalies

研究组 & 干预措施

EPL and CEI

Experimental

Those with receive a standard epidural (EPL) and continuous epidural infusion(CEI) + patient-controlled epidural analgesia (PCEA)

干预措施: EPL and CEI (Other)

DPE and CEI

Active Comparator

Those with receive a dural puncture labor epidural (DPE) and continuous epidural infusion(CEI) + patient-controlled epidural analgesia (PCEA)

干预措施: DPE and CEI (Other)

DPE and PIEB

Active Comparator

Those with receive a dural puncture labor epidural (DPE) and programmed intermittent epidural boluses(PIEB) + patient-controlled epidural analgesia (PCEA)

干预措施: DPE and PIEB (Other)

结局指标

主要结局

Compare time of onset of labor analgesia among the study groups

时间窗: From epidural infusion initiate to delivery

Visual Numerical Rating Scale (VNRS) ≤ 10 mm on a 100-mm scale

次要结局

  • Total anesthetic dose required(From epidural infusion initiate to 1h post delivery)
  • Incidence of side effect(24 hours post delivery)
  • Sensory block level(24 hours post delivery)
  • Mode of delivery(From epidural infusion initiate to delivery)
  • Apgar scores(30 mins post delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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