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临床试验/NCT01204892
NCT01204892已完成不适用

Postoperative Pain After Laparoscopic Cholecystectomy in Patients Receiving Bilateral Ultrasound-guided Transverse Abdominis Plane Block Compared With Local Anesthetic Infiltration of Trochar Insertion Sites With Ropivacaine 0.5%

Baylor College of Medicine2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2010年9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
80
试验地点
2
主要终点
Pain

研究概览

简要总结

The purpose if to find out if analgesia with bilateral ultrasound-guided Tranversus Abdominis Plane (TAP) block with Ropivacaine 0.5% is better than analgesia with local infiltration of trochar sites with Ropivacaine 0.5% in patients undergoing laparoscopic cholecystectomy.

Our hypothesis is that in laparoscopic cholecystectomy, bilateral TAP blocks will reduce postoperative pain scores when compared to conventional postoperative pain control with local infiltration of trochar insertion sites.

详细描述

The purpose if to find out if analgesia with bilateral ultrasound-guided Tranversus Abdominis Plane (TAP) block with Ropivacaine 0.5% is better than analgesia with local infiltration of trochar sites with Ropivacaine 0.5% in patients undergoing laparoscopic cholecystectomy.

Our hypothesis is that in laparoscopic cholecystectomy, bilateral TAP blocks will reduce postoperative pain scores when compared to conventional postoperative pain control with local infiltration of trochar insertion sites.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient ages 18-64
  • American Society of Anesthesiology Physical Status I, II or III
  • Inpatients scheduled to undergo laparoscopic cholecystectomy at Ben Taub General Hospital

排除标准

  • Open cholecystectomy - excluded due to increased levels of pain in open procedures
  • Scheduled for ambulatory surgery
  • Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications
  • Coagulopathy or anticoagulation - increased risk of bleeding from nerve block injection
  • Allergy or contraindication to any of the study medications or anesthetic agents
  • Chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone
  • Patient inability to properly describe postoperative pain to investigators (language barrier, dementia, delirium, psychiatric disorder)
  • Patient or surgeon refusal

结局指标

主要结局

Pain

时间窗: 24 hours

Pain scores on NAS scale (0-10) at the following times: Preop, Time 0, Time 1, Time 2, Time 4, Time 8, Time 12, Time 24

次要结局

  • Narcotics use(24 hours)
  • PONV (Postoperative nausea and vomiting)(24 hours)

研究者

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

Jaime Ortiz

Assistant Professor of Anesthesiology

Baylor College of Medicine

研究点 (2)

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