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临床试验/NCT03634111
NCT03634111已完成不适用

The Transversus Abdominis Plane Block

Gia Dinh People Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年7月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Total morphine consumption during 24 hours

研究概览

简要总结

The transversus abdominis plane block (TAP block) has effect to postoperative analgesia for cesarean section with spinal anesthesia but it was limited for cesarean section with general anesthesia. The hypothesis that this technique has effect to postoperative analgesia for cesarean section with general anesthesia and it could reduce 50% of total morphine consumption during 24 hours after surgery.

详细描述

This is a randomized, controlled, no-blind clinical trial. The investigators selected 60 cases, who were cesarean section under general anesthesia, age from18 years, and American Society Anesthesiologists (ASA) classification was from II-III. The cases of acute fetal impairment, local anesthesia contraindication, tolerance opioids, liver failure, renal failure, and spinal anesthesia failure were excluded. All cases were randomized assigned two groups: the TAP block group (T group) and controlled group (C group). Each group has 30 cases. The TAP block was performed under the ultrasound guidance with 0.25% of ropivacaine 20 ml each side. The both groups was treated postoperative analgesia with intravenous morphine to patients controlled analgesia (PCA). The primary outcome was total morphine consumption during 24 hours after surgery. The secondary outcomes were the time of required the first dose of morphine, pain score, the complications of TAP block, the side effects of morphine, and satisfaction score of participants. Data was described and analyzed with SPSS 25.0. The sample size was calculated with the hypothesis that TAP block could reduce 50% of dose morphine during 24 hours after surgery, 80% of power, 10% of loss, and 0.05 of alpha error.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

盲法说明

Participants were cesarean section with general anesthesia

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Cesarean section with general anesthesia.
  • The ASA classification was from II to III

排除标准

  • The acute fetal impairment.
  • The severe live or renal failure.
  • Tolerance opioids

研究组 & 干预措施

T group

Active Comparator

The TAP block group was called T group. The participants were performed TAP block under guidance at the end of surgery.

干预措施: TAP block (Procedure)

T group

Active Comparator

The TAP block group was called T group. The participants were performed TAP block under guidance at the end of surgery.

干预措施: Morphine (Drug)

T group

Active Comparator

The TAP block group was called T group. The participants were performed TAP block under guidance at the end of surgery.

干预措施: Ropivacaine (Drug)

C group

Placebo Comparator

The controlled group was called C group. The participants has not TAP block and were treated postoperative analgesia with intravenous morphine to patients controlled analgesia

干预措施: Morphine (Drug)

C group

Placebo Comparator

The controlled group was called C group. The participants has not TAP block and were treated postoperative analgesia with intravenous morphine to patients controlled analgesia

干预措施: Ropivacaine (Drug)

结局指标

主要结局

Total morphine consumption during 24 hours

时间窗: 24 hours

Morphine was intravenous perfusion to participants during 24 hours with patients controlled analgesia (PCA).

次要结局

  • The time required the first of dose of morphine (hours)(24 hours)
  • Pain score: VAS(24 hours)
  • The rate of complications of TAP block(24 hours)
  • The rate of side effect of morphine(24 hours)
  • The satisfaction of participants: Likert(24 hours)

研究者

发起方
Gia Dinh People Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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