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临床试验/NCT02259374
NCT02259374Unknown不适用

Use of Tap Block in Patients After Hysterectomy

Singapore General Hospital0 个研究点目标入组 54 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
54
主要终点
Morphine consumption in the first 24 hours

研究概览

简要总结

TAP block performed under ultrasound guidance is used as part of multimodal analgesia to relieve pain after abdominal surgery in our hospital. Choices of local anaesthetic used include bupivacaine and ropivacaine. Local anaesthetic works by inhibiting nerve transmission of pain from the site of tissue injury. An important component of the pain experienced by patients after abdominal surgery derives from the abdominal wall incision. The abdominal wall sensory afferents course through the transversus abdominis (neurofascial) plane superficial to the transversus abdominis muscle. Single shot TAP block has been shown to provide pain relief of up to 24h in surgeries involving pfannenstiel incisions, hence a study period of 24h is chosen in patients undergoing hysterectomy.

This study was designed to test the hypothesis that the TAP block, as part of a multimodal analgesic regimen, even at a lower concentration, would provide effective analgesia in the first 24 h after hysterectomy, in comparison to a higher concentration of 0.4% ropivacaine.

详细描述

Our study hypothesis is that TAP block performed with 0.2% ropivacaine is not inferior to that using 0.4% ropivacaine.

The primary outcome measure in this study was 24 h morphine consumption. Secondary outcome measures included time to first request for morphine, VAS scores, and side effects associated with morphine consumption which include nausea, vomiting, sedation, pruritus, as well as patient satisfaction.

Our study hypothesis is that TAP block performed with 0.2% ropivacaine 40ml is not inferior to that using 0.4% ropivacaine 40ml, in terms of analgesia in the first 24h.

Primary Objectives Morphine consumption in the first 24h should not differ between the 2 groups by more than 10mg.

Secondary Objectives Secondary objectives are to show that morphine side effects are similar in the two groups if a lower ropivacaine provides similar pain relief as higher concentration. Patient satisfaction is also recorded.

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, Investigator)

入排标准

年龄范围
21 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • - ASA 1-3
  • age 21-60
  • undergoing open hysterectomy as planned by the surgeons
  • able to provide informed consent. A upper limit age of 60 is chosen because elderly patients may have reduced requirements for analgesia and may be more sensitive to effects of opioids.

排除标准

  • - chronic pain/ opioid usage
  • allergy to study drugs
  • Weight <50

结局指标

主要结局

Morphine consumption in the first 24 hours

时间窗: 24hours

次要结局

  • Morphine side effects(24 hours)
  • Patient satisfaction(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

thong sze ying

ASSOCIATE CONSULTANT

Singapore General Hospital

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