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 compared with ropivacaine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
89
Drug: HR18034 Drug: Ropivacaine Hydrochloride Injection Local nerve block of Ropivacaine Hydrochloride Injection to produce anesthesia for surgery and analgesia in postoperative pain management. Other Name: Ropivacaine Hydrochloride Injection, 0.5% Injectable Solution
Dongguan People's Hospital
Dongguan, Guangdong, China
AUC0-72 of the NRS-R pain intensity scores.
AUC of NRS pain intensity scores at rest (NRS-R) through 72 hours after the beginning of study drug administration.
Time frame: 0 to 72 hours
AUC of the NRS-R pain intensity scores.
AUC of NRS pain intensity scores at rest (NRS-R) for time periods 0-24, 0-48 hours.
Time frame: 0-24, 0-48 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, 0-72 hours.
Time frame: 0-24, 0-48, 0-72 hours
Pain intensity assessed using an 11-point NRS ranging.
11-point Numercal Rating Scale ranging from a score of 0 to 10. Pain-free defined as an NRS of 0 or 1. Worst imaginable pain defined as an NRS of 10
Time frame: Baseline till 72 hours after the beginning of study drug administration
Proportion of subjects who used no rescue opioid analgesic.
Proportion of subjects who used no rescue opioid analgesic through 0-24, 24-48, 48-72 and 0-72 hours after the beginning of study drug administration.
Time frame: 0-24, 24-48, 48-72, 0-72 hours
Total rescue analgesic consumption.
Total rescue analgesic consumption through 0-24, 24-48, 48-72 and 0-72 hours after the beginning of study drug administration.
Time frame: 0-24, 24-48, 48-72, 0-72 hours
Time to the first postoperative use of rescue opioid analgesics.
Time to the first postoperative use of rescue opioid analgesics 0-72 hours after the beginning of study drug administration.
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Time frame: 0-72hours
Quadriceps muscle strength score.
Quadriceps muscle strength score at 6, 8, 12, 16, 20, 24, 36, 48 and 72 hours.
Time frame: Baseline till 72 hours after the beginning of study drug administration
Subjects' satisfaction rating
Subjects' satisfaction rating with postsurgical pain control at 72 hours.
Time frame: 72 hours
Investigators' satisfaction rating
Investigators' satisfaction rating with postsurgical pain control at 72 hours.
Time frame: 72 hours