Phase Ⅱ, randomized, double-blind, comparator-controlled study to evaluate the efficacy, safety and pharmacokinetics of single injection adductor canal block with HR18034 for postoperative pain management in total knee arthroplasty compared with ropivacaine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
15
HR18034
Ropivacaine Hydrochloride Injection
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
AUC0-72h of the NRS-A pain intensity scores.
AUC of NRS pain intensity scores at activity (NRS-A) through 72 hours after the beginning of study drug administration.
Time frame: 0 to 72 hours
AUC of the NRS-A pain intensity scores.
AUC of NRS pain intensity scores at activity (NRS-A) for time periods 0-24, 0-48 hours.
Time frame: 0-24, 0-48hours
AUC of the NRS-R pain intensity scores.
Time frame: 0-24, 0-48,0-72 hours
AUC of NRS pain intensity scores at rest (NRS-R) for time periods 0-24, 0-48 ,0-72 hours.
Time frame: 0-24, 0-48 ,0-72 hours.
Pain intensity assessed using an 12-point NRS ranging.
Time frame: Baseline till 72 hours after the beginning of study drug administration
Proportion of subjects who used no rescue opioid analgesic.
Time frame: 0-24, 24-48, 48-72, 0-72 hours
Total rescue analgesic consumption.
Time frame: 0-24, 24-48, 48-72, 0-72 hours
Time to the first postoperative use of rescue opioid analgesics.
Time frame: 0-72hours
Quadriceps muscle strength score.
Time frame: Baseline till 72 hours after the beginning of study drug administration
Range of motion of the knee joint.
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Time frame: Baseline till 72 hours after the beginning of study drug administration
Subjects' satisfaction rating
Time frame: 72 hours
Investigators' satisfaction rating
Time frame: 72 hours