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临床试验/NCT03181438
NCT03181438Unknown不适用

Efficacy of Ultrasound-guided Transverse Abdominal Plane Block for Analgesia in Renal Transplantation

Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2017年6月3日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
42
试验地点
2
主要终点
Morphine Consumption

研究概览

简要总结

The objective of this study is to evaluate the efficacy and safety of transverse abdominal plane block in patients undergoing renal transplant surgery.Adult renal transplant recipients will be prospectively randomized to receive a standard general anesthetic technique supplemented with ropivacaine 0.375% 20 mL TAP block or sham block with 20 mL 0.9% saline. Both groups will receive patient-controlled morphine analgesia. Patient assessment will occur in the postanesthetic care unit and at 1, 2, 4, 6, 12, and 24 hours. The primary outcome is total morphine consumption in the first 24 hours after renal transplantation. Other outcomes asses include pain scores, presence of nausea or vomiting, excessive sedation, and respiratory depression.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • end-stage renal disease undergoing cadaveric renal transplantation

排除标准

  • Contraindications to the use of morphine
  • Contraindications to the use ropivacaine
  • Peripheral neuropathy
  • Inability to use a Patient Control Analgesia device

结局指标

主要结局

Morphine Consumption

时间窗: 24 hours post-operative

Patient Control Analgesia: morphine sulfate 2 mg IV every 5 minutes until visual analog scale pain score (0 = no pain, 10 = worst possible pain) is 3 or less, and continued at the following settings for a 24-hour period: 1 mg bolus, 7-minute lockout, and 30 mg maximum 4-hourly dose.

次要结局

  • Pain Score(24 hours post-operative)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Leonardo Henrique Cunha Ferraro

Professor

Federal University of São Paulo

研究点 (2)

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