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
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 1
- 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
研究组 & 干预措施
A
Active Comparator
Patients randomized to receive thoracic paravertebral nerve blockade in addition to general endotracheal anesthesia during video assisted thoracoscopy procedure
干预措施: Thoracic Paravertebral Nerve Block (Procedure)
B
Sham Comparator
Patients randomized to receive sham single-injection thoracic peripheral nerve blockade (no injection) in addition to general endotracheal anesthesia
干预措施: Thoracic Paravertebral Nerve Block (Procedure)
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 (1)
Loading locations...
相似试验
已完成
不适用
Local or Regional or General Anesthesia for Hernia Repair: a Randomized Controlled TrialAnesthetics Adverse ReactionHerniaInflammationNCT01845376Mingkwan Wongyingsinn, MD54
Unknown
不适用
Postoperative Inflammation and Recovery After TracheostomyTracheostomy ComplicationInflammationPost-operative ComplicationsNCT02096640Sormland County Council, Sweden150
Unknown
4 期
On-pump Beating Coronary Artery Bypass Grafting by Ventricular AssistCoronary Artery BypassNCT02731794Henan Institute of Cardiovascular Epidemiology70
已完成
不适用
Effect of Different Final Irrigation Protocols on Postoperative Endodontic Pain in Devital TeethPostoperative PainEndodontically Treated TeethNCT04310254Istanbul Medipol University Hospital90
招募中
不适用
Differences in Postoperative Symptoms With Four Ureteral StentsUrinary StoneNCT06083051University of Wisconsin, Madison272