Phase Ⅱ, randomized, double-blind, comparator-controlled study to evaluate the efficacy, safety and pharmacokinetics of single injection intercostal nerve block with HR18034 for postoperative pain management compared with ropivacaine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
96
HR18034 228mg/342mg/456mg
Ropivacaine Hydrochloride Injection 60mg/90mg/120mg
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGAUC0-72 of the NRS-A (or cough) 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 (or cough) pain intensity scores.
AUC of NRS pain intensity scores at activity (NRS-A) or cough for time periods 0-12, 12-24, 12-48, 12-72 hours.
Time frame: 0-12, 12-24,12-48, 12-72 hours
AUC of the NRS-R pain intensity scores.
AUC of NRS pain intensity scores at rest (NRS-R) for time periods 0-12, 12-24,12-48, 12-72, 0-72 hours.
Time frame: 0-12, 12-24,12-48, 12-72, 0-72 hours
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.
Time frame: 0-72 hours
Subjects' satisfaction rating
Subjects' satisfaction rating with postsurgical pain control at 72 hours.
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Time frame: 72 hours
Investigators' satisfaction rating
Investigators' satisfaction rating with postsurgical pain control at 72 hours.
Time frame: 72 hours