A multicenter, randomized, double-blind, placebo-controlled, and positive-controlled phase II clinical trial was conducted to evaluate the efficacy and safety of HSK55718 injection for postoperative analgesia in patients undergoing abdominal surgery. The primary objective was to evaluate the efficacy of HSK55718 for postoperative analgesia after abdominal surgery. The secondary objective was to evaluate the safety and pharmacokinetic profile of TRD303 solution for postoperative analgesia after abdominal surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
NRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, the first dose of HSK55718 injection 15mg was given intravenously, and then 7.5mg HSK55718 injection or normal saline was given intermittently every 6 hours
NRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, the first dose of HSK55718 injection 60mg was given intravenously, and then 30mg HSK55718 injection or normal saline was given intermittently every 6 hours.
NRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, the first dose of HSK55718 injection 120mg was given intravenously, and then 60mg HSK55718 injection or normal saline was given intermittently every 6 hours
NRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, morphine injection 2mg was given intravenously as the first dose, and then morphine injection 2mg was given intermittently every 6 hours
NRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, normal saline solution was given intravenously as the first dose, and then normal saline solution was given intermittently every 6 hours
The Third Xiangya Hospital of Central South University, Changsha, hunan
Changsha, Hunan, China
RECRUITINGSichuan Provincial People's Hospital
Chengdu, Sichuan, China
RECRUITINGThe time-weighted summed pain intensity differences over 24 h (SPID0-24 h) at rest
The time-weighted summed pain intensity differences during 0-24 hours (SPID0-24 h) at rest after the first dose
Time frame: From administration until 24 hours after administration
the time-weighted summed pain intensity differences (SPID) at rest
The time-weighted summed pain intensity differences during 0-12h, 12-24h, 24-48h, and 0-48h (SPID0-12h、SPID12-24h、SPID24-48h、SPID0-48h) at rest after the first dose
Time frame: From administration until 12 hours, 48 hours after administration, from 12 hours to 24 hours and 24 hours to 48 hours after administration.
Pain intensity differences (PID)
The rest pain intensity difference (PID) was calculated at each scoring time point after the first dose, and PID was the difference between the NRS score at each time point and the baseline NRS score
Time frame: From administration until 48 hours after administration
The proportion of NRS pain score ≤3
Time frame: From administration until 48 hours after administration
Time to onset
Time frame: From administration until 12 hours after administration
Cumulative use of rescue analgesics during each period
Time frame: From the time of administration to 24 hours and 48 hours after administration
Time of first sufentanil rescue analgesia
Time frame: From administration until 48 hours after administration
Proportion of rescue analgesia
Time frame: From administration until 48 hours after administration
Postoperative analgesia satisfaction score
At 24 hours after the end of the study, participants recalled the analgesic effect of the postoperative analgesia and rated their satisfaction on a scale of 0 to 10, with 0 indicating dissatisfied and 10 very satisfied.
Time frame: From administration until 48 hours after administration
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