A single-center randomized, open-label, prospective study to evaluate efficacy and safety of DDK(Drug delivery kit, Welpass) for pain relief after gynecologic laparotomy surgery

Asan Medical Center0 个研究点目标入组 110 人开始时间: 待定最近更新: 2023年10月16日

研究概览

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•1) Those who signed and sealed the clinical trial subject’s written consent to participate in the trial
•2) Those who are over 18 years of age but under 80 years of age
•3) Patients scheduled for open surgery for benign gynecological diseases using a transverse abdominal incision (Pfannenstiel)
•4) Adequate hematological function, liver function, and renal function confirmed in preoperative examination
•5) Patients scheduled to use a self-administered pain control device (PCA)

•1) Patients with a history of hypersensitivity to Ropivacaine or other amide-based local anesthetics
•2) Patients with or history of hypersensitivity to fentanyl, its components, or other opioid drugs
•3) Patients suffering from massive bleeding or shock
•4) Patients with confirmed active (excluding asymptomatic urinary tract infection) or uncontrolled systemic infection
•5) Patients who have continuously taken narcotic analgesics within 4 weeks before registration
•6) Underweight (BMI 18.5 or less) or severe obesity (BMI 30 or more)
•7) Currently have severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, hepatic, renal, neurological, or metabolic disease)
•8) If you have high blood pressure that cannot be controlled with appropriate medication
•9) Patients who have a thrombotic disorder or are receiving antithrombotic therapy
•10) Patients who are pregnant or breastfeeding
•11) Patients who participated in another clinical trial within 30 days before participating in the trial

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