The Cardio-pulmonary and Analgesic Effects of Pre-peritoneal Infusion VS Epidural Infusion of Levo - Bupivacaine on Patients Undergoing Major Upper Abdominal Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- change in Respiratory mechanics
研究概览
简要总结
60 Patients will be randomly assigned using computer generated randomization program (http://www.randomizer.org) into two groups, First group (Control group ,Group of continous epidural infusion [CEI]), where patients will receive continuous epidural infusion of L-bupivacaine 0.125 % at a rate of .1 ml/kg/h during the first 48 hours after surgery. Second group (Group of continous preperitoneal infusion [CPI]), where patients will receive continuous pre-peritoneal wound infusion with L-bupivacaine 0.25% at 10 ml/h during the first 48 hours after surgery.
详细描述
All patients will receive IV morphine when needed for a period of 48 hours with a PCA device programmed to deliver 1 mg/dose with a 10-minute lockout time without background infusion.
CEI group The epidural catheter will be placed via a paramedian approach as close as possible to the surgical procedure via the inter-vertebral space (from T7 to T10) so that the affected dermatomes of the surgical wound would receive the benefits of bupivacaine infusion. Proper placement of the catheter was verified through an aspiration test and a test dose (2 ml) of lidocaine 2%. At the end of surgery, a 14 ml bolus of L-bupivacaine 0.125 will be administered through the catheter and then a continuous rate of .1 ml/kg/h infusion of L-bupivacaine 0.125 will be delivered.
CPI group At the end of surgery and after the closure of the peritoneal layer, the catheter will be allocated above the peritoneum within the musculofascial layer and secured to the skin with an occlusive dressing. Thereafter, a 20 ml bolus of L-bupivacaine 0.25% will be administered through the catheter and then a continuous fixed-rate infusion of L-bupivacaine 0.25% will be delivered.
Outcome Measures The primary outcome will be the pulmonary effects including
. Respiratory mechanics: Forced Vital Capacity (FVC) &Forced Expiratory Volume in one second (FEV1) will be assessed preoperatively and at 12h, 24h and 48 hours postoperatively.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients subjected to major upper abdominal cancer surgery.
- •The enrolled age will be from 18 years to 70 years
- •ASA, I-III and NYHA, I-III.
排除标准
- •ASA physical status and NYHA >III,
- •pregnant women,
- •body mass index >40 kg/m2,
- •preoperative opioid consumption,
- •Contraindications or patient's refusal of epidural analgesia, and inability to use a PCA device.
- •Contraindications of use of spirometry device :
- •A) Cerebral aneurysm, Recent brain surgery, recent concussion, recent eye surgery& Significant glaucoma.
- •B) Recent sinus surgery or middle ear surgery or infection. C) Pneumothorax, Significant aortic aneurysm, Recent thoracic surgery or Recent abdominal surgery .
- •D) Systemic hypotension or severe hypertension (eg, >200/120 mmHg), Significant atrial/ ventricular arrhythmia , Noncompensated heart failure , Recent myocardial infarction or pulmonary embolus.
- •E) History of syncope related to forced exhalation/cough. F) Active tuberculosis , Hemoptysis or oral bleeding . 7-Uncooperative patients regarding use of spirometry [Inability to follow directions (eg, confusion, dementia, young age, language barrier)].
结局指标
主要结局
change in Respiratory mechanics
时间窗: preoperative-Day 1 & Day2 postoperative
Forced Vital Capacity (FVC) \&Forced Expiratory Volume in one second (FEV1) will be assessed preoperativly and at Day 1 \& Day2 postoperative.
次要结局
- change in Visual analogue pain score(immediately postoperative then at 2 hours, 4hours ,6hours ,12hours, 24hours ,36hours &48 hours after surgery)
- change in Cardiac enzymes levels(preoperatively and postoperative Day 1 and Day 2.)
研究者
Mohammed Farghaly Abd El hamid Ahmed
assisstant lecturer
South Egypt Cancer Institute