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临床试验/NCT02029755
NCT02029755已完成不适用

Ultrasound-guided-transversus Abdominis Plane(TAP) Block Versus Local Anesthetic(LA) Infiltration-the Effectiveness of Post-operative Pain Control in the Abdominal Surgery

Taipei Medical University Hospital2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
108
试验地点
2
主要终点
Opioid Consumption

研究概览

简要总结

Postoperative analgesia is an important part of the anesthetic care. According to the recent studies, multimodal analgesia can provide better analgesia & patient satisfaction with fewer side effect. For example, combining intravenous, intramuscular or oral analgesics with transversus abdominis plane (TAP) block or local anesthetic (LA) infiltration as the multimodal analgesia, can furnish a more effective pain control after the abdominal surgery.

For abdominal surgery, both local infiltration and TAP block target on relieving somatic pain. Local anesthetic wound infiltration is easy to perform with low risk. As the advancement of ultrasound technology, performing the TAP block also becomes easier, safer and more accurate. But whether LA infiltration or TAP block is better for the multimodal analgesia regimen remains unclear.

This study is to compare the postoperative pain score, opioid consumption, side effects, and quality of recovery between these two analgesic methods in patients undergoing abdominal surgery. The investigators hypothesized that TAP block may be more effective than LA infiltration as a part of the multimodal analgesia, and can improve the recovery after the abdominal surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • Adult (20~65y/o)
  • American Society of Anesthesiologists (ASA) physical status I~II
  • Patients scheduled for regular abdominal surgery under general anesthesia

排除标准

  • ASA physical status ≥ 3
  • Allergy to morphine or local anesthetics
  • Morphine tolerance
  • Drug abuse or addiction
  • Bleeding tendency

结局指标

主要结局

Opioid Consumption

时间窗: postoperative 48 hour

opioid consumption of the participants will be followed at postoperative 1, 6, 12, 24, 36, 48 hour (up to 48 hours).

Pain Score (NRS: Numerical Rating Scale)

时间窗: postoperative 24 hour dynamic

pain scores of the participants will be followed at postoperative 1, 6, 24, 48 hour (up to 48 hours). (NRS: from 0 to 10, 0 = no pain, 10 = the worst pain) The higher score idicates the worse outcome.

次要结局

  • Sedation Scale(postoperative 1, 6, 24, 48 hour)
  • Nausea and Vomiting Categorical Score(postoperative 1, 6, 24, 48 hour)
  • Rescue Antiemetics Use(postoperative 1, 6, 12, 24, 36, 48 hour)
  • Time to the First Request of Analgesics(an expected average of 5 days)
  • Heart Rate Variability(preoperative, postoperative 1 hour and 1 day)
  • Length of Hospital Stay(an expected average of 5 days)
  • Rescue Analgesic Use(postoperative 1, 6, 12, 24, 36, 48 hour)
  • Time to Flatus(an expected average of 5 days)
  • Quality of Recovery 40(postoperative 48 hour)
  • Pruritus(postoperative 1, 6, 24, 48 hour)
  • Number of Participants With Intervention-related Complication(an expected average of 5 days)

研究者

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

hsiao chien tsai

fellow researcher

Taipei Medical University Hospital

研究点 (2)

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