The Effect of Dexamethasone on the Duration and Functionality of Bupivacaine Intercostal Nerve Blockade
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Post operative pain
研究概览
简要总结
The proposed study is a randomized, double-blinded, non-placebo-controlled evaluation of the effect of the addition of dexamethasone to intraoperative intercostal nerve block bupivicaine solutions on the duration of pain relief and post operative pulmonary function.
详细描述
Our study proposes two groups of 25 patients undergoing similar VATS surgery with a single surgeon, Dr. R. McKenna, who will receive interoperatively placed intercostal nerve blocks at the same levels. Each group will receive intercostals nerve blocks with one of two different solutions: group one will receive intercostal nerve blocks with only 0.46% bupivacaine (19.5 ml of 0.5% bupivacaine + .5 cc saline), group 2 will receive intercostal blocks with 0.46% bupivacaine and dexamethasone(19.5 ml of 0.5% bupivacaine + .5ml .4% dexamethasone). The patients will have pulmonary lung function objectively assessed by portable spirometry and clinical factors both preoperatively and postoperatively. Our study objective is to examine and quantify the potentially beneficial effects of intercostal nerve blockade prolongation with dexamethasone on postoperative pulmonary function and postoperative recovery.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 80 years old of either gender, scheduled for unilateral VATS procedure with Dr. McKenna for resection of lung tumor.
排除标准
- •ASA IV and above
- •Intolerance, allergy, or contraindication to use of any medications used in this study
- •Significant coronary artery disease (abnormal stress test, myocardial infarction within the last 3 months)
- •Uncontrolled hypertension (BP > 140/90)
- •History of prior ipsilateral thorascopic surgery
- •Cardiac arrhythmias particularly prolonged QT syndrome
- •Drugs known to cause prolonged qT: class IA antiarrhythmics (quinidine, procainamide, dysopyramide), class III antiarrhythmics (sotalol, dofetalide, ibutalide, amiodarone), haloperidol, thioridazine, arsenic trioxide, HIV protease inhibitors, tricyclic antidepressants
- •Individuals with significant psychological disorders including: schizophrenia, mania, bipolar disorder or psychosis
- •Pregnant or lactating women
- •Morbid obesity (BMI > 40 kg/m2) AND/OR weight > 150 kg
- •Chronic renal failure ( creatinine > 2.0 mg/dL)
- •Liver failure e.g., active cirrhosis
- •Alcohol or substance abuse within in the past 3 months
- •Uncorrected hypokalemia, hypomagnesemia, hypocalcemia (can be due to diuretics, mineralocorticoid use, laxatives)
- •Restrictive lung disease (pulmonary fibrosis, myasthenia gravis) or FEV1 or FEV less than 70% of predicted value.
- •Type 2 diabetes
- •Neuropathic pain
- •Chronic opioid consumption (>30mg oxycodone or greater per day)
- •Cahexia from any cause
- •systemic use of corticosteroids for greater than 2 weeks in the 6 months prior to surgery
研究组 & 干预措施
Group 2
an intercostal nerve block with a solution consisting of 0.46% bupivicaine (19.5 ml of 0.5% bupivicaine + .5ml .4% dexamethasone)
干预措施: Bupivacaine and Dexamethasone (Drug)
Group 1
an intercostal nerve block with a solution consisting of 0.46% bupivicaine (19.5 ml of 0.5% bupivicaine + .5ml normal saline)
干预措施: Placebo (Drug)
结局指标
主要结局
Post operative pain
时间窗: 72 hours post operatively
Patients will be evaluated for post operative pain using the NRS pain evaulation
次要结局
未报告次要终点
研究者
dermot Maher
Resident Department of Anesthesia
Cedars-Sinai Medical Center