Efficacy of intralesional infusion of local anesthetics in patients undergoing major abdominal surgery: a randomized double-blind trial. - PT-SM-13-YR

Fondazione IRCCS Policlinico San Matteo0 个研究点目标入组 120 人开始时间: 2013年3月22日最近更新: 2018年2月26日

适应症

试验速览

暂无简介。

•- Male and females 18-75 years old scheduled to use PCA with morphine for postoperative pain control
•- HIV-negative
•- Classification American Society of Anesthesiologists (ASA) I: without systemic disease
•- Classification ASA II or III (moderate systemic disease or severe systemic disease that limits activity without disability)
•- Scheduled for major abdominal and urologic surgery (no emergency surgery)
•- Signed informed consent
•- No severe hepatic or renal impairment (cholinesterase <3000 mU / ml, total bilirubiemia <2 mg / dl and creatinine <1.2 mg / dl)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 90
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•- regular use of opioid analgesics;
•- History of abuse of drugs and / or alcohol;
•- Postoperative hospitalization in intensive care with sedation and / or mechanical ventilation;
•- severe renal impairment (creatinine> 2 g / dl, creatinine clearance <30 ml / h) and / or hepatic impairment (cholinesterase <2000 IU);
•- Cardiac disorders (arrhythmias, heart failure);
•- Neurological disorders (epilepsy);
•- Cognitive disorders, mental retardation, psychiatric disorders;
•- Changes in the normal coagulation or coagulopathy (INR> 2, PTT> 44 sec);
•- Platelet count less than 100.000/mm3;
•- BMI> 30;
•- immunodepression (WBC<5.000)
•- Allergy to study drugs.

发起方