Clinical trial to compare efficacy and safety of 'PF-72', a sustained-release drug delivery system that is injected into the incision site during surgical operation after mixing with 0.75% ropivacine for the purpose of reducing postoperative pain, with 0.75% ropivacine in patients undergoing laparoscopic gastrectomy or laparoscopic colorectal surgery

TGelBio Co., Ltd.0 个研究点目标入组 108 人开始时间: 待定最近更新: 2019年11月5日

适应症

试验速览

暂无简介。

•1. Adults aged 19 to 70
•2. American society of anesthesiologist physical status 1, 2 or 3
•3. Patients with elective surgery scheduled for laparoscopic gastrectomy for gastric cancer or for laparoscopic colon resection for colon cancer
•4. Patients without clinically significant abnormal findings in laboratory tests
•5. Patients who decided to voluntarily participate in the trial and who agreed in writing to the consent of the study ethics review committee

•1. Patients scheduled for laparotomy
•2. Patients requiring emergency surgery
•3. Patients with a history of intra-abdominal organs resection
•4. Patients with pain greater than zero at the site of surgery on the abdomen, evaluated on the preoperative 100 mm visual analog scale (VAS)
•5. Patients scheduled for resection of the organs other than the stomach or colon
•6. Patients with cognitive impairment that do not complain of subjective pain
•7. Patients who weighed less than 50 ? for men and less than 45 ? for women
•8 Body mass index more than 35 kg/m2
•9. septic patients
•10. Women who were pregnant or lactating
•11. Clinically significant impairment of cardiovascular, hepatic, or renal function; history of cardiac arrhythmia
•12. Use of pre-operative analgesic or neuroleptic medication
•13. History of substance abuse or psychiatric disease

发起方

TGelBio Co., Ltd.