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临床试验/NCT03333902
NCT03333902已完成不适用

The Comparison Of Different Nerve Blocks For Postoperative Analgesia In Cesarean Delivery: A Randomized Controlled Trial

Feng Xia1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2017年12月1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
发起方
入组人数
102
试验地点
1
主要终点
the change trend of Visual Analogue Scale (VAS) at rest and movement

研究概览

简要总结

The purpose of this study is to investigate the effect of different kinds of popular peripheral nerve blocks for postoperative analgesia after cesarean delivery is completed, compared with traditional epidual analgesia.

详细描述

Visual Analogue Scale (VAS) and morphine consumption was adopted to evaluate the pain relief.

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, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • American Society of Anesthesiologists (ASA) physical status I or II
  • weight from 50 to 70 kilogrammes
  • a normal singleton pregnancy
  • ≥37 weeks gestation

排除标准

  • congenital coagulopathy
  • anatomic abnormalities
  • localized skin infection
  • allergy to any of the drugs used

研究组 & 干预措施

QLB type 2

Experimental

Ultrasound-guided, Inject at the point posterior to quadratus lumborum muscle, 0.2% ropivacaine 30mL in each side for a total of 60mL.

Subjects also receive an intravenous patient controlled analgesia (PCA) pump of 0.5 mg/mL morphine for 48 hours.

干预措施: QLB (Procedure)

QLB type 2

Experimental

Ultrasound-guided, Inject at the point posterior to quadratus lumborum muscle, 0.2% ropivacaine 30mL in each side for a total of 60mL.

Subjects also receive an intravenous patient controlled analgesia (PCA) pump of 0.5 mg/mL morphine for 48 hours.

干预措施: Intravenous patient controlled analgesia (PCA) (Procedure)

QLB type 3

Experimental

Ultrasound-guided, Inject at the point between the quadratus lumborum and the psoas major muscle, 0.2% ropivacaine 30mL in each side for a total of 60mL.

Subjects also receive an intravenous patient controlled analgesia (PCA) pump of 0.5 mg/mL morphine for 48 hours.

干预措施: QLB (Procedure)

QLB type 3

Experimental

Ultrasound-guided, Inject at the point between the quadratus lumborum and the psoas major muscle, 0.2% ropivacaine 30mL in each side for a total of 60mL.

Subjects also receive an intravenous patient controlled analgesia (PCA) pump of 0.5 mg/mL morphine for 48 hours.

干预措施: Intravenous patient controlled analgesia (PCA) (Procedure)

QLB type 2+3

Experimental

Ultrasound-guided, conduct both QLB type 2 and 3, 0.2% ropivacaine 15mL in each point of injection, for a total of 60mL.

Subjects also receive an intravenous patient controlled analgesia (PCA) pump of 0.5 mg/mL morphine for 48 hours.

干预措施: QLB (Procedure)

QLB type 2+3

Experimental

Ultrasound-guided, conduct both QLB type 2 and 3, 0.2% ropivacaine 15mL in each point of injection, for a total of 60mL.

Subjects also receive an intravenous patient controlled analgesia (PCA) pump of 0.5 mg/mL morphine for 48 hours.

干预措施: Intravenous patient controlled analgesia (PCA) (Procedure)

epidural anesthesia group (EA)

Active Comparator

Epidural catheter placement was conducted when finishing spinal anesthesia. After surgery, 30 mL saline (placebo) was Injected at the point posterior to the quadratus lumborum in each side for a total of 60mL. We used a single bolus of 0.15% ropivacaine + 2 mg morphine (diluted in 6 ml saline) via epidural cathether.

Subjects also receive an intravenous patient controlled analgesia (PCA) pump of 0.5 mg/mL morphine for 48 hours.

干预措施: QLB (Procedure)

epidural anesthesia group (EA)

Active Comparator

Epidural catheter placement was conducted when finishing spinal anesthesia. After surgery, 30 mL saline (placebo) was Injected at the point posterior to the quadratus lumborum in each side for a total of 60mL. We used a single bolus of 0.15% ropivacaine + 2 mg morphine (diluted in 6 ml saline) via epidural cathether.

Subjects also receive an intravenous patient controlled analgesia (PCA) pump of 0.5 mg/mL morphine for 48 hours.

干预措施: Intravenous patient controlled analgesia (PCA) (Procedure)

结局指标

主要结局

the change trend of Visual Analogue Scale (VAS) at rest and movement

时间窗: 0-48 hours postoperatively

The purpose is to view the change of the level of pain assessed by subjects at adjacent time points. We would set 0, 4, 6, 12, 24, 48 hours postoperatively as observational time points.

次要结局

  • total morphine consumption(0-48 hours postoperatively)
  • complications(0-48 hours postoperatively)

研究者

发起方
Feng Xia
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Feng Xia

Professor

First Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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