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临床试验/NCT02475031
NCT02475031已完成4 期

Randomized, Prospective, Double Blind Study Comparing Single Shot Versus Continuous Transverses Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Live Donor Nephrectomy

Indiana University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
70
试验地点
1
主要终点
Total Narcotic Usage at 48 Hours

研究概览

简要总结

The purpose of this study is to determine whether continuous transversus abdominis plane (TAP) block is superior to single shot TAP for postoperative pain after laparoscopic donor nephrectomy

详细描述

This study is a randomized, prospective, double blind study comparing single shot versus continuous transversus abdominis plane (TAP) block for postoperative analgesia after laparoscopic live donor nephrectomy.

Good pain control after surgery has been shown to decrease complications. To address the problem of postoperative pain control in donor nephrectomy patients,the study investigators began performing Transversus Abdominis Plane (TAP) blocks. The TAP block involves injection of local anesthetic between the abdominal muscle planes (internal oblique muscle and transversus abdominis muscle), to block the somatic nerves that supply sensation to the skin, muscles, and parietal peritoneum of the anterior abdominal wall. Prior reports of TAP blocks have shown that it provides good analgesia for postoperative pain after abdominal surgery. However because the duration of postoperative pain exceeds that of the single shot TAP block, the investigators hypothesized that by placing a catheter through which a continuous infusion of local anesthetic could be delivered, investigators could provide analgesia throughout the postoperative period. The study investigators also hypothesized that improved analgesia would decrease the need for opioid pain medications, hence decreasing the side effects associated with opioid use.

This study is designed to test our hypothesis that placing a TAP catheter is superior to single shot TAP, because it provides a longer duration of analgesia and decreases narcotic use.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Placebo Group (TAP-S)

Placebo Comparator

(TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter

干预措施: TAP-S (Drug)

Active Group (TAP-C)

Active Comparator

(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter

干预措施: TAP-C (Device)

结局指标

主要结局

Total Narcotic Usage at 48 Hours

时间窗: 48 hours

The primary endpoint of this study will be narcotic requirement at 48 hours

次要结局

  • Sedation Scores at 48 Hours(48 hours)
  • Secondary Endpoints Measured Will be Total Narcotic Usage at 60 Hours(up to 60 hours)
  • Average Pain Scores(up to 60 hours)
  • Nausea Scores at 48 Hours(up to 48 hours)

研究者

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

Yar Yeap

Assistant Professor of Clinical Anesthesia

Indiana University

研究点 (1)

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