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临床试验/NCT03946982
NCT03946982已完成不适用

Comparisons Between Low Thoracic and Lumbar Epidural Analgesia on Postoperative Pain Management Qualities After Cesarean Delivery: a Randomized Controlled Trial

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2019年5月28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
189
试验地点
1
主要终点
Pain intensity

研究概览

简要总结

Whether low thoracic epidural analgesia improves postoperative cesarean pain qualities than conventional lumbar epidural analgesia?

详细描述

Postoperative pain remains the leading cause of concern in women faced with undergoing a cesarean delivery. Inadequate acute pain management is associated with numerous negative effects, including delayed postpartum recovery, interference with mother-child bonding because postoperative pain limits breastfeeding, and a high risk of postpartum depression and persistent pain.

Epidural analgesia (EA) is being increasingly preferred to systemic opioid because of better analgesic effect. Although EA is widely used for cesarean delivery, the effect of the site of epidural catheter insertion on the quality of postoperative pain management remains inadequately investigated. For example, placement of the epidural catheter in the low thoracic intervertebral spaces may be more suitable for catheter-incision-congruent analgesia during caesarean delivery than in the lumbar intervertebral space; however, epidural catheter insertion is conventionally recommended at the lumbar intervertebral space. Therefore, in this study, we aim to investigate the difference in post-cesarean pain control quality between low thoracic EA and lumbar EA.

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 (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •age between 20-yr and 50-yr parturients
  • •elective cesarean delivery

排除标准

  • •contraindicated to regional anesthesia, eg. coagulopathy (INR> 1.5; platelet< 80000...etc)
  • •significant co-morbidities, eg. preeclamspia, heart failure with New York Heart Association (NYHA) Classification> class 2
  • •allergy to opioids or local anesthetics

研究组 & 干预措施

Low thoracic epidural morphine

Active Comparator

干预措施: low thoracic epidural (Procedure)

Lumbar epidural morphine

Active Comparator

干预措施: lumbar epidural (Procedure)

Lumbar epidural patient controlled epidural analgesia

Active Comparator

干预措施: lumbar epidural (Procedure)

Low thoracic patient controlled epidural analgesia

Experimental

干预措施: low thoracic epidural (Procedure)

结局指标

主要结局

Pain intensity

时间窗: postoperative two days

pain intensities in three category, namely static, dynamic and uterine cramping, gauged by a 100 mm visual analogue scale

Proportion of women with a visual analogue scale> 33 mm

时间窗: postoperative two days

次要结局

  • Adverse effects(postoperative two days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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