Safety and Efficacy of Patient Controlled Analgesia using the Sublingual Sufentanil Tablet System (SSTS) in a fast track rehabilitation program after Total Knee Arthroplasty.

Ghent University Hospital0 个研究点目标入组 156 人开始时间: 2019年11月20日最近更新: 2022年5月23日

适应症

试验速览

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•Consenting male and female patients
•between the age of 40 – 75 years, who are admitted for
•elective total knee arthroplasty, qualify for a fast track rehabilitation program with early mobilization and early hospital discharge, understand the Patient controlled analgesia (PCA) principle and are capable to operate the SSTS device.
•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 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 56

•-Outside age range
•-Contra indication for anti-inflammatory drugs
•-Revision total knee arthroplasty
•-history of substance abuse,
•-pregnancy ,lactation
•-severe hepatic impairment (INR>1,5 and/or AST/ALT above x3 highest normal value),
•-sleep apnea (documented by sleep laboratory study),
•-severe chronic kidney disease (eGFR<30 mL/min/1.73 m2),
•-severe and very severe COPD (GOLD III and IV)
•-opioid tolerance (use of >15mg oral morphine equivalent per day within the past 3 months),
•-chronic pain conditions necessitating gabapentinoids, steroids
•-hypersensitivity to sufentanil
•-significant respiratory depression (need for outpatient supplemental oxygen therapy),
•-participation in another clinical trial

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