NCT00639795终止不适用
Prospective Randomized Trial Evaluating the Effects of Paravertebral Nerve Blocks on Postoperative Pain and the Perioperative Inflammatory Response Following Video Assisted Thorascopic Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Comparing the degree of systemic post-operative inflammation with the degree of post-operative pain
研究概览
简要总结
The purpose of this study is to compare:
- The degree of systemic postoperative inflammation (cytokine measurement) with the degree of post-operative pain
- The degree of pain and nausea and
- The pre and post operative pulmonary functions
following Video Assisted Thorascopic Surgery (VATS) performed under general anesthesia with the addition of intra-operative single-injection paravertebral blockade vs general anesthesia with a sham intra-operative paravertebral nerve blockade
详细描述
- Enrolled subjects scheduled to undergo video-assisted thorascopic surgery (VATS) will be randomized to receive either paravertebral block or placebo(adhesive bandage applied at the site).
- All patients will undergo a standardized general anesthetic regimen.
- Human biological specimens will be collected preoperatively, postoperatively (in the PACU) at the first morning blood draw of POD 1, POD 2, POD 3, and POD 10-14 (follow-up visit at surgeons office)and analyzed for CRP, Cortisol & inflammatory markers (IL-1beta,IL-2,IL-4,IL-5,IL-6, IL-8, IL-10,INF-gamma, TNF-alpha)
- Pulmonary functions (FEV1/FEV6) will be performed in the pre-op holding area prior to sedation and post-operatively on the morning of post-op day 1.
- Pain levels will be assessed with the Wong-Baker Faces and Visual Analog Scale pre-operatively in the PACU and hourly for a total of 6 hours and then every 8 hrs.and with patient self-report in diary after discharge.
- Pain levels will be assessed with the McGill-Melzack Pain Questionnaire pre-operatively, the evening of POD1-POD3 and by patient self-report in diary after discharge.
- Nausea assessments will occur at arrival on floor and every 8 hours thereafter until discharge.
- Narcotic requirements will be collected daily in the hospital and by patient self report in diary thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Age greater than 18
- •Planned thoracoscopy with low probability(by surgeon estimate) of conversion to open procedure
排除标准
- •Age less than 18
- •Clinical or laboratory evidence of systemic infection
- •Current pregnancy as assessed by preoperative urine HCG test
- •Serious, uncontrolled, non-malignant illness
- •Malignant illness requiring systemic chemotherapy in the last 6 months
- •Documented allergy to oxycodone, morphine sulfate or acetaminophen
- •Contraindication to peripheral nerve blockade or general anesthesia including:
- •patient refusal
- •active infection at site of planned block
- •documented allergy to any local or general anesthetic medications
- •significant coagulopathy( prothrombin time >15 seconds, INR>1.5
- •pre-existing neuropathy and medical conditions or deformities which would compromise block or anesthetic safety
- •Planned pleurodesis
- •Current use of high dose inhaled or systemic steroids
- •Current use of Amiodarone (Cordarone)
- •Morbid obesity (BMI=40kg/m2)
- •Patients with clinically significant mental health issues such as psychosis requiring treatment with antipsychotic medications.
- •Patients unable to consent
- •Patients with active infections requiring antibiotics within one month of registration
- •Participation in other clinical trials that may interfere with this study
结局指标
主要结局
Comparing the degree of systemic post-operative inflammation with the degree of post-operative pain
时间窗: 1 year
次要结局
- To compare the degree of pain and nausea(1 year)
研究者
研究点 (2)
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