Randomized Prospective Study Comparing Paravertebral Catheters, Single Shot Paravertebral Block, Thoracic Epidural, for Postoperative Analgesia Following Video-assisted Thoracoscopic Surgery
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
- 否
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
US Guided Single Shot Paravertebral Block
干预措施: US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion) (Drug)
Group #2
US Guided Paravertebral Catheter
干预措施: US Guided Paravertebral Catheter (0.2% ropivicaine bolus) (Drug)
Group #3
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
Yar Yeap
Director, Acute Pain Service Assistant Professor of Clinical Anesthesiology Indiana University School of Medicine Department of Anesthesiology
Indiana University
