This is a multicenter, randomized, double-blind, placebo-controlled, two-stage phase II clinical study. The main objective is to evaluate the efficacy and safety of HSK21542 injection and explore the recommended dose and administration frequency for subsequent Phase II studies in conjunction with the pharmacodynamic (PD) and pharmacokinetic (PK) characteristics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
124
Once preoperative and once each at 0, 8, and 16 h postoperative, for a total of 4 administrations
Once preoperative and once each at 0, 8, and 16 h postoperative, for a total of 4 administrations
once each at 0, 8, and 16 h postoperative, for a total of 3 administrations
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
Sum of Pain Intensity Differences (SPID)
The time-weighted SPID at rest within 0-24 h after the first postoperative administration in each group
Time frame: Frome administration until 24 hours after administration
Sum of Pain Intensity Differences (SPID)
The time-weighted sum of pain intensity differences of the rest pain in each group within 0-12 h after the first postoperative dose
Time frame: Frome administration until 24 hours after administration
Use of remedial analgesics
Cumulative dose of remedial analgesics (mg of morphine injection) in each group within 0-12 h and 0-24 h after the first postoperative dose, the percentage of subjects in each group who have not used remedial analgesics, and the time to start using remedial analgesics
Time frame: Frome administration until 24 hours after administration
Pain Intensity Differences(PID)
The PID at rest at each scoring time point after the first postoperative administration in each group
Time frame: Frome administration until 24 hours after administration
The proportion of subjects with a NRS of ≤ 3
The proportion of subjects in each group with a resting pain NRS of ≤ 3 at 12 h and 24 h after the first postoperative dose
Time frame: Frome administration until 24 hours after administration
Duration of analgesia
The duration of analgesia after the first postoperative administration in each group
Time frame: Frome administration until 24 hours after administration
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once each at 0, 8, and 16 h postoperative, for a total of 3 administrations
once each at 0, 8, and 16 h postoperative, for a total of 3 administrations
once each at 0, 8, and 16 h postoperative, for a total of 3 administrations
once each at 0, 8, and 16 h postoperative, for a total of 3 administrations
Satisfaction scores on postoperative analgesia
Subject satisfaction score and investigator satisfaction score on postoperative analgesia at 24 h after the first postoperative administration in each group
Time frame: Frome administration until 24 hours after administration