Ultrasound Guided Paravertebral Catheter Versus Patient Controlled Analgesia for Postoperative Pain Control in Video Assisted Thoracoscopic Surgery: A Prospective Outcomes Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Maximum NRS Pain score
研究概览
简要总结
Level I randomized prospective outcomes study comparing two groups of patients. One group will receive Dilaudid patient controlled analgesia (PCA) post-operatively. The other will receive an ultrasound guided paravertebral block with indwelling paravertebral catheter with an infusion of 0.2% Ropivicaine post-operatively and a PCA.
详细描述
Design: Level I randomized prospective outcomes study comparing two groups of patients. One group will receive Dilaudid patient controlled analgesia (PCA) post-operatively. The other will receive an ultrasound guided paravertebral block with indwelling paravertebral catheter with an infusion of 0.2% Ropivicaine post-operatively and a PCA.
Sample Size: 50 patients Study Duration: Approximately 24 months Population:. Patients presenting to the University of Minnesota Medical Center for elective Video Assisted Thoracoscopic Surgery (VATS), for thoracic, lung, or mediastinal lesions or masses.
Primary Objective: To determine if post-operative paravertebral catheters in patients with elective VATS procedures result in decreased pain compared to patients treated with PCA for post-operative pain.
Secondary Objectives:
- To determine whether the use of paravertebral catheters impacts the length of ICU and hospital stay for patients, compared to a PCA in patients undergoing elective Video Assisted Thoracoscopic Surgery (VATS).
- To determine whether the use of paravertebral catheters leads to lower risk of complications, compared to use of a PCA in patients undergoing elective Video Assisted Thoracoscopic Surgery (VATS).
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• All patients undergoing elective VATS.
排除标准
- •• Previous difficult airway or multiple previous intubations
- •History of myasthenic syndrome
- •Systemic infection
- •Pre-existing sensory deficit
- •PT >14 or PTT >40 sec
- •Platelet count less than 50,000
- •Creatinine > 1.5
- •Allergy to local anesthetics
- •Patients who remain intubated for one week after surgery or who are unable to provide information as to their feelings of pain post-operatively for the first week post-operatively
- •Use of a spinal or epidural anesthetic for surgery
- •Daily use of opioid for more than a week
- •Lack of patient cooperation
- •Contraindication to regional anesthesia
- •Infection at injection site
- •Inability to guarantee sterile equipment or sterile conditions for the block
- •Patient refusal
- •Risk of local anesthetic toxicity
- •Coagulopathy or bleeding disorder
- •Severe respiratory disease (where the patient depends on intercostal muscle function for ventilation);
- •Ipsilateral diaphragmatic paresis;
- •Severe spinal deformities (kyphosis or scoliosis)
- •Previous thoracotomy
研究组 & 干预措施
Paravertebral catheter
a paravertebral catheter is placed and an elastomeric pump is connected to infuse 0.2% ropivacaine postoperatively
干预措施: Paravertebral catheter (Device)
Paravertebral catheter
a paravertebral catheter is placed and an elastomeric pump is connected to infuse 0.2% ropivacaine postoperatively
干预措施: Ropivacaine (Drug)
Paravertebral catheter
a paravertebral catheter is placed and an elastomeric pump is connected to infuse 0.2% ropivacaine postoperatively
干预措施: Elastomeric Pump (Device)
IV PCA
opioid PCA consisting of hydromorphone is connected to patient in the post anesthesia care unit
干预措施: opioid iv pca (Device)
结局指标
主要结局
Maximum NRS Pain score
时间窗: 0-24 hours after surgery
pain at movement or maximum in first 24 hours after surgery
次要结局
- total opioid use(the first 5 days after surgery)
- length of stay(time until patient is ready to be discharged or is discharged, expected 5 days)