Evaluation of Safety and Efficacy of Etodolac Injection in Patients with Post-Operative Orthopedic Pain.

Ipca Laboratories Limited0 个研究点目标入组 541 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1) Male and female patients aged between 18 and 65 years.
•2) Patients undergoing open reduction and internal fixation of long bone fracture surgery.
•3) Patients with the post operative orthopedic pain of at least 5 cm on the 10 cm pain intensity VAS and at least a score if 2 on 4 point VRS
•4) Patients fulfilling the American Society of Anesthesiology (ASA) physical status classification of Class I and Class II
•5) Patients able to understand and willing to fully comply with study procedures and restrictions
•6) Patients ready to give informed consent, as per applicable regulatory requirements, for participation in the study.

•1) Patients who are unable to remain at the hospital for the duration of the study.
•2) Patients having complication during or after surgical procedure.
•3) Patients with systemic infection before the surgery is performed
•4) Patients with abnormal renal function (Serum Cr >1.5 mg/dL)
•5) Patients with abnormal liver function (AST and ALT, total bilirubin or alkaline phosphatase more than 2.5 times the upper limit of normal values)
•6) Patients with known history of HIV 1 or HIV 2, Hepatitis B or C viruses or syphilis infection or malignancy
•7) Patients with dementia, other cognitive impairment prohibiting informed consent.
•8) Patients with any other clinically significant abnormality(ies) interfering with assessment of disease under evaluation.

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