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临床试验/NCT02180893
NCT02180893已完成4 期

Study of Paravertebral Block for Cardiac Surgery

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Postoperative Fentanyl

研究概览

简要总结

Pain after robotic cardiac surgery is a known problem and is often difficult to manage. Paravertebral nerve blocks are a proven method of pain relief following thoracotomy. A paravertebral block has been shown to provide good pain relief with minimal side effects, however, paravertebral blocks for robotic surgery have not been well studied. Currently the investigators routinely perform PVB on this patient population (of 50 MV robotic cases done between January and October 2012, 36 received paravertebral blocks with no adverse events noted). The investigators believe this should be studied further and that paravertebral blocks will reduce the amount of additional pain medication patients require in the first 24 hours after surgery, decrease intubation time and improve PACU and hospital discharge times.

详细描述

Pain after robotic cardiac surgery is a known problem and is often difficult to manage. Paravertebral nerve blocks are a proven method of pain relief following thoracotomy. A paravertebral block has been shown to provide good pain relief with minimal side effects, however, paravertebral blocks for robotic surgery have not been well studied. Currently we routinely perform PVB on this patient population (of 50 MV robotic cases done between January and October 2012, 36 received paravertebral blocks with no adverse events noted). We believe this should be studied further and that paravertebral blocks will reduce the amount of additional pain medication patients require in the first 24 hours after surgery, decrease intubation time and improve PACU and hospital discharge times.

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
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients over the age of 18 years of age undergoing robotic mitral valve surgery.
  • have capacity to understand and sign consent form

排除标准

  • patients that are not candidates for paravertebral block as per ASRA guidelines (Horlocker, Reg Anesth Pain Med, 2010). In short, this includes patients taking specific anti platelet agents such as clopidigrel, anticoagulants such as heparin or low molecular weight heparin, or patients with an INR of greater than 1.
  • patients with a history of COPD or other respiratory diseases that would confound data on time to extubated will be excluded.
  • Patients that with a diagnosis of chronic pain, or patients currently taking narcotics are excluded, as this would confound data on postoperative narcotic requirements.

结局指标

主要结局

Postoperative Fentanyl

时间窗: 24 hours

Visual Analog Scale (VAS) Pain Scores

时间窗: 24 hours

Possible scores range from 0-10, with 0 being no pain and 10 being highest level of pain

次要结局

  • Participant Satisfaction(48 hours)
  • Participant Satisfaction Score(48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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