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临床试验/NCT03151434
NCT03151434已完成3 期

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

Indiana University1 个研究点 分布在 1 个国家目标入组 147 人开始时间: 2017年2月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
147
试验地点
1
主要终点
The Primary Endpoint of This Study Will be VAS Pain Score at 24 Hours

研究概览

简要总结

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.

详细描述

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.

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
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

  • 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

排除标准

  • 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

研究组 & 干预措施

Group #1

Active Comparator

US Guided Single Shot Paravertebral Block

干预措施: US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion) (Drug)

Group #2

Active Comparator

US Guided Paravertebral Catheter

干预措施: US Guided Paravertebral Catheter (0.2% ropivicaine bolus) (Drug)

Group #3

Active Comparator

Thoracic Epidural

干预措施: Thoracic Epidural (0.125% bupivicaine/hydromorphone) (Drug)

结局指标

主要结局

The Primary Endpoint of This Study Will be VAS Pain Score at 24 Hours

时间窗: 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

The Primary Endpoint of This Study Will be VAS Pain Score at 48 Hours

时间窗: 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

次要结局

  • Secondary Endpoint Includes Total Intravenous Opioid Consumption at 72 Hours(Opioid consumption will be measured at 1 hour post op, 24,48, and 72 hours post op. The total amount will be recorded.)

研究者

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

Yar Yeap

Director, Acute Pain Service Assistant Professor of Clinical Anesthesiology Indiana University School of Medicine Department of Anesthesiology

Indiana University

研究点 (1)

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