Name (Synonyms) | Correlation |
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There is one clinical trial.
Primary objective: The primary objective of this study is to evaluate either a) the postsurgical total opioid consumption or b) postsurgical pain control after presurgical iovera° treatment plus EXPAREL® and standardized multimodal therapy compared with presurgical sham iovera° treatment plus EXPAREL and standardized multimodal therapy in subjects undergoing primary unilateral total knee arthroplasty (TKA). A single primary objective, either a or b, will be declared by an unblinded Independent Review Committee (IRC) in an interim analysis after 30 randomized and treated subjects complete the Day 42 assessments. The primary objective not selected will be placed in the secondary objectives category. Secondary objectives: The secondary objectives of this study are to compare postsurgical pain control or postsurgical total opioid consumption (whichever is not chosen as the primary objective), opioid-free status, physical function, sleep quality, and safety of presurgical iovera° treatment plus EXPAREL and standardized multimodal therapy with presurgical sham iovera° treatment plus EXPAREL and standardized multimodal therapy in subjects undergoing primary unilateral TKA
Description: NRS scale is 0 to 10 with 0 being no pain and 10 being the worst pain
Measure: The area under the curve (AUC) of the Numeric Rating Scale (NRS) "worst pain" intensity scores from TKA (Day 1) to Day 42 (6 weeks post-TKA) Time: Day 1 to Day 42Description: NRS scale is 0 to 10 with 0 being no pain and 10 being the worst pain
Measure: Numeric Rating Scale (NRS) pain intensity scores "right now" at Day 15, 30, 42, and Day 90 Time: Day 15 to Day 90Description: NRS scale is 0 to 10 with 0 being no pain and 10 being the worst pain
Measure: Numeric Rating Scale (NRS) pain intensity scores "average pain" at Day 4 to Day 42 Time: Day 4 to Day 42