HSK16149 for Perioperative Analgesia in Orthopedic Surgery
Post-operative Pain
About this trial
This is an interventional treatment trial for Post-operative Pain
Eligibility Criteria
Inclusion Criteria: Male or female between the ages of 18 and 75 years (included); Elective orthopedic surgery under general anesthesia, expected operation time ≤4 hours and postoperative morphine analgesia time ≥24 hours; 18kg/m^2≤BMI≤30 kg/m^2; American Society of Anesthesiologists (ASA) grade I and II; Exclusion Criteria: Any of the following medical histories or conditions prior to screening: Long history of chronic pain; history of severe cardiovascular or respiratory disease; history of neurological or psychiatric disorders; history of acute poisoning with alcohol, hypnotics, analgesics or other drugs acting on the central nervous system; major surgery within 3 months; patients with high bleeding risk; history of renal disease treated with dialysis within 28 days before surgery; have active infection within the past 2 weeks; Use of any of the following medications or treatments: opioid analgesics for more than 10 consecutive days within 3 months prior to screening; other analgesics before randomization if the last dose was taken less than 5 half-lives of the drug (according to the label); Abnormal laboratory tests during screening: Hypertension that is not adequately controlled by antihypertensive drugs (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg), or systolic blood pressure ≤90 mmHg during screening; A history of drug abuse, and/or alcohol abuse in the 3 months prior to screening; Participated in another clinical trial and received IMP within 30 days prior to screening; Pregnant or lactating women; Unwillingness to use reliable contraceptive methods from the time of screening until 28 days after the last dose of IMP;
Sites / Locations
- Dongguan People's Hospital
- Foshan Fuxing Chancheng Hospital
- The First Affiliated Hospital of Jinan University
- Affiliated Hospital of Guizhou Medical University
- Beijing Jishuitan Hospital Guizhou Hospital
- Zunyi University Affiliated Hospital
- Henan Provincial People's Hospital
- People's Hospital of Wuhan University
- Wuhan Central Hospital
- Xiangya Third Hospital of Central South University
- The First Affiliated Hospital of South China University
- Lianyungang First People's Hospital
- Nanjing First Hospital
- Chengdu Second People's Hospital
- Chengdu Third People's Hospital
- Sichuan Provincial People's Hospital
- Guangyuan First People's Hospital
- Mianyang Central Hospital
- Yibin Second People's Hospital
- The First People's Hospital of Yunnan Province
- Sino-Japanese Friendship Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Preoperative administration of HSK16149 40mg
Preoperative administration of HSK16149 60mg
Preoperative and postoperative administration of HSK16149 40mg
Preoperative and postoperative administration of HSK16149 60mg
placebo
HSK16149 40mg will be administered the night before and 2h before surgery
HSK16149 60mg will be administered the night before and 2h before surgery
HSK16149 40mg will be administered orally the night before surgery, 2h before surgery, 4h and 16h after surgery
HSK16149 60mg will be administered orally the night before surgery, 2h before surgery, 4h and 16h after surgery
The placebo will be administered orally the night before surgery, 2h before surgery, 4h and 16h after surgery