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临床试验/NCT03570996
NCT03570996终止不适用

A Randomized Controlled Trial Comparing Transversus Abdominis Plane Catheter Versus Epidural After Esophagectomy

Swedish Medical Center2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
38
试验地点
2
主要终点
Pain scores

研究概览

简要总结

A randomized trial comparing perioperative outcomes between bilateral transversus abdominis plane TAP catheters with patient controlled analgesia (PCA) to epidural for esophagectomy patients with a VATS chest approach. Further objectives are to determine pain requirements between multiple modalities of pain control and compare the subsequent sequelae of narcotic use and blood pressure control and to compare complications such as anastomotic leak, atrial fibrillation and perioperative morbidity and mortality between the two groups.

详细描述

Epidural analgesia is considered the 'gold standard' for post-operative analgesia following open esophagectomy. Epidurals have been shown to reduce post-operative pulmonary morbidity and mortality. However, epidurals are often associated with sympathetic blockade that creates hypotension and could therefore adversely affect the conduit. Pain management techniques that use peripheral nerve blockade are becoming more prevalent, reducing the need for an epidural. Transversus abdominis plane (TAP) catheters have been used in colorectal and abdominal surgery showing equivocal pain scores to epidurals. With the minimally invasive chest approach, the analgesia coverage focuses on the abdominal incision where both epidurals and TAPs are considered standard of care.

The investigators have completed a retrospective study in preparation for a randomized control trial. The investigators previous retrospective study found that TAP blocks/catheters are a reasonable alternative to epidurals, providing adequate pain coverage for abdominal incisions. The study found no statistical difference in pain scores between the two groups. The TAP group had a lower prevalence of hypotension and lower crystalloid resuscitation needs. Pulmonary complications were similar between the two groups. This retrospective review showed that TAP blocks are a reasonable alternative to epidurals and may reduce episodes of hypotension. The investigators aim is to now expand this study to a randomized control trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

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

  • All adult individuals who undergo an esophagectomy with a minimally invasive approach of the chest at Swedish Medical Center-First Hill. These approaches include:
  • 3 hole with R video-assisted thoracoscopic surgery (VATS)
  • Ivor Lewis R VATS
  • Transhiatal

排除标准

  • Unable to consent
  • Additional surgical procedures planned
  • Patient with chronic pain on a daily regimen of narcotics
  • Patients who remain intubated greater than 24 hours post operatively
  • Non-English speaking

结局指标

主要结局

Pain scores

时间窗: Up to post-operative day 4

Pain scores on a scale of 0-10 will be collected from patients twice a day

次要结局

  • Volume Resuscitation(Up to post-operative day 4)
  • Hypotension(Up to post-operative day 4)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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