Ultrasound Guided Bilateral Paravertebral Catheters Versus Thoracic Epidural Analgesia for Post- Operative Pain Control in Open Pancreatic Surgery: A Prospective Outcomes Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- total Maximal Pain scored via NRS 0-10 scale
研究概览
简要总结
Design: Level I randomized prospective outcomes study comparing two groups of patients. One group will receive bupivacaine and dilaudid thoracic epidural analgesia (PCA) post-operatively. The other will receive bilateral ultrasound guided paravertebral blocks with indwelling paravertebral catheters with an infusion of 0.2% ropivicaine post-operatively and a PCA.
Sample Size: 50 patients Study Duration: Approximately 12 months Population:. Patients presenting to the University of Minnesota Medical Center for elective open pancreatic surgery.
Primary Objective: To determine if bilateral paravertebral catheters in patients with open pancreatic procedures result in decreased pain compared to patients treated with thoracic epidural for post-operative pain.
Secondary Objectives:
- To determine whether the use of bilateral paravertebral catheters impacts the length of ICU and hospital stay for patients, compared to a thoracic epidurals in patients undergoing elective open pancreatic surgery.
- To determine whether the use of ultrasound guided bilateral paravertebral catheters leads to lower risk of complications, compared to use of a thoracic epidural in patients undergoing open pancreatic surgery.
详细描述
Design: Level I randomized prospective outcomes study comparing two groups of patients. One group will receive buipvacanine and dilaudid thoracic epidural analgesia (PCA) post-operatively. The other will receive bilateral ultrasound guided paravertebral blocks with indwelling paravertebral catheters with an infusion of 0.2% ropivicaine post-operatively and a PCA.
Sample Size: 50 patients Study Duration: Approximately 12 months Population:. Patients presenting to the University of Minnesota Medical Center for elective open pancreatic surgery.
Primary Objective: To determine if bilateral paravertebral catheters in patients with open pancreatic procedures result in decreased total maximal pain scores compared to patients treated with thoracic epidural for post-operative pain.
Secondary Objectives:
- To determine whether the use of bilateral paravertebral catheters impacts the length of ICU and hospital stay for patients, compared to a thoracic epidurals in patients undergoing elective open pancreatic surgery.
- To determine whether the use of ultrasound guided bilateral paravertebral catheters leads to lower risk of complications, compared to use of a thoracic epidural in patients undergoing open pancreatic surgery.
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
- Single (Outcomes Assessor)
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 open pancreatic surgery.
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 or chronic pain syndrome
- •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;
研究组 & 干预措施
Standard of Care
Epidural placed for postoperative pain control
干预措施: Epidural (Procedure)
Experimental Intervention
Bilateral paravertebral catheters placed for postoperative pain control
干预措施: Paravertebral catheters (Procedure)
结局指标
主要结局
total Maximal Pain scored via NRS 0-10 scale
时间窗: on postoperative day 1 through postoperative day 5
maximal pain scored via NRS 0-10 scale assessed by independent assessor
次要结局
- Length of stay(when the patient meets discharge criteria or is discharged home, expected length of stay 10 days)
- Nausea/vomiting(the first five days postoperatively)
- Maximal Pain scored via NRS 0-10 scale(on postoperative day 5)