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Comparison of Three Different Pain Blocks for Subjects Undergoing VATS (Video Assisted Thoracoscopic Surgery) Procedure. (VATS)

2021年1月7日 更新者:Yar Yeap、Indiana University

Randomized Prospective Study Comparing Paravertebral Catheters, Single Shot Paravertebral Block, Thoracic Epidural, for Postoperative Analgesia Following Video-assisted Thoracoscopic Surgery

The purpose of this study is to compare three different pain control methods on subjects who are scheduled to undergo VATS (video-assisted thoracoscopic surgery) procedures. The study will compare their pain scores, narcotic needs, patient satisfaction scores, and narcotic side effects.

研究概览

详细说明

All patients will be consented on the morning of surgery. All the thoracic epidurals and ultrasound-guided paravertebral blocks will be placed preoperatively. The procedures will be done using sterile technique with masks, hats, and sterile gloves. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.

Thoracic epidurals will be placed using the Arrow thoracic epidural kit. The epidural will be placed at the appropriate level to cover the entry site for the VATS procedure. Placement will be determined by anatomical landmarks. The epidural needle will be advanced toward the epidural space utilizing a Paramedian approach and loss-of-resistance technique. A sterile catheter will then be secured in place and the epidural infusion will be started at the end of the case.

Ultrasound guided paravertebral catheter and single shot paravertebral block will be accomplished using an ultrasound transducer at the thoracic level. This will be done using an in-plane or out-of-plane approach, at the discretion of the anesthesia staff performing the procedure. Then a needle will be inserted the needle into the paravertebral space and local anesthetic injected. Then a catheter will be placed within the injectate and secured in place in the case of the paravertebral catheter. The 0.2% Ropivicaine will be delivered by OnQ pump.

General anesthesia will be induced and the patient will be placed in the lateral position for the VATS procedure. The patients will be intubated with dual lumen endotracheal tubes and placed on one-lung ventilation for the procedure.

All patients will receive intravenous patient-controlled analgesia (PCA hydromorphone) post-operatively for breakthrough pain. They will also be scheduled on PO acetaminophen. PO oxycodone PRN will be started on POD 1 once patients tolerate diet.

Opioid usage at 1,24,48,72 hours after the block will be recorded by a member of the research team. Pain scores at rest and on movement (knee flexion) will be measured by the investigator using Visual Analog Scale (VAS). Nausea will be measured using a categorical scoring system (none=0; mild=1; moderate=2; severe=3). Sedation scores will also be assessed by a member of the study team using a sedation scale (awake and alert=0; quietly awake=1; asleep but easily roused=2; deep sleep=3). All these parameters will be measured at 1, 24, 48 and 72 hours after the epidural or PVB. Patients will be encouraged to ambulate on postoperative day 1 under supervision.

All catheters will be removed by APS (Acute Pain Service) while patients are still in the hospital. APS will continue to follow the patients until catheter removal. Patient's hospital length of stay and readmission rate will be recorded from NSQIP (National Surgical Quality Improvement Program) data.

All patients will receive a phone call 6 months after surgery for assessment for chronic post-surgical pain. Patients will be assessed by a member of the research team over the phone. They will be assessed on their pain score and narcotic usage by using the Brief Pain Inventory. Study participation will conclude after the 6 month follow questionnaire has been completed.

研究类型

介入性

注册 (实际的)

147

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Indiana
      • Indianapolis、Indiana、美国、46202
        • Indiana University Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Pt undergoing VATS procedure at Indiana University Hospital
  • ASA 1,2,3 or 4
  • Age 18 or older, male or female
  • Desires Regional anesthesia for postoperative pain control

Exclusion Criteria:

  • Any contraindication for Thoracic Epidural or Paravertebral block
  • History of substance abuse in the past 6 months
  • Patient staying intubated after surgery
  • Known allergy or other contraindications to the study medications , which include dilaudid, bupivacaine, ropivacaine

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Group #1
US Guided Single Shot Paravertebral Block
Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.
其他名称:
  • US Guided Single Shot Paravertebral Block
有源比较器:Group #2
US Guided Paravertebral Catheter
Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.
其他名称:
  • US Guided Paravertebral Catheter
有源比较器:Group #3
Thoracic Epidural
Epidural catheter will be placed in the thoracic region prior to surgery.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The Primary Endpoint of This Study Will be VAS Pain Score at 24 Hours
大体时间:Pain scores will be measured 24 hours after surgery.
The VAS score will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using "units on a scale" of 1-10 for documentation with 10 being the worst pain and 0 being no pain
Pain scores will be measured 24 hours after surgery.
The Primary Endpoint of This Study Will be VAS Pain Score at 48 Hours
大体时间:Pain scores will be measured 48 hours after surgery.
The VAS scores will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using"units on a scale" scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
Pain scores will be measured 48 hours after surgery.

次要结果测量

结果测量
措施说明
大体时间
Secondary Endpoint Includes Total Intravenous Opioid Consumption at 72 Hours
大体时间:Opioid consumption will be measured at 1 hour post op, 24,48, and 72 hours post op. The total amount will be recorded.
Opioid consumption will be collected by a study team member post operatively up to 3 days per protocol time requirements
Opioid consumption will be measured at 1 hour post op, 24,48, and 72 hours post op. The total amount will be recorded.

其他结果措施

结果测量
措施说明
大体时间
Average Nausea Scores Over 72 Hours
大体时间:Nausea scores will be documented at 1 hour post op, 24,48,and 72 hours after the surgery.The scores will then be averaged.
Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as 0=none, 1=mild, 2=moderate, or 3=severe
Nausea scores will be documented at 1 hour post op, 24,48,and 72 hours after the surgery.The scores will then be averaged.
Average Sedation Scores Over 72 Hours
大体时间:Sedation scores will be documented at 1 hour post op, 24,48,and 72 hours after the sugery. The scores will then be averaged.
Sedation scores will be documented by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is 0=awake and alert, 1=quietly awake, 2=asleep and arousable, or 3=deep sleep.
Sedation scores will be documented at 1 hour post op, 24,48,and 72 hours after the sugery. The scores will then be averaged.
Subjects Overall Satisfaction Scores
大体时间:post operatively at hour 24
Subjects will be followed up at 24 hours post operatively by a study team member to document patient overall satisfaction scores. Score was recorded as 0=dissatisfied, 1=satisfied, 2=very satisfied.
post operatively at hour 24
Subjects Overall Satisfaction Scores
大体时间:post operatively at hour 48
Subjects will be followed up at 48 hours post operatively by a study team member to document patient overall satisfaction scores. Scores will be recorded as 0=dissatisfied, 1=satisfied, 2=very satisfied.
post operatively at hour 48

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年2月7日

初级完成 (实际的)

2018年7月30日

研究完成 (实际的)

2018年7月30日

研究注册日期

首次提交

2017年3月22日

首先提交符合 QC 标准的

2017年5月10日

首次发布 (实际的)

2017年5月12日

研究记录更新

最后更新发布 (实际的)

2021年1月27日

上次提交的符合 QC 标准的更新

2021年1月7日

最后验证

2021年1月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

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是的

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