Postoperative Pain Management
Conditions
Brief summary
This is a multi-center, randomized, double-blind, placebo/active-controlled study. 405 subjects undergoing orthopedic surgery under general anesthesia are planned to be enrolled and randomized into the HSK21542 group, morphine group, and placebo group.
Interventions
DRUGHSK21542
Patients administrated with HSK21542
DRUGPlacebo
Patients administrated with placebo
DRUGmorphine
Patients administrated with morphine
Sponsors
Haisco Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* 18 years old ≤ age ≤74 years old, regardless of gender; * 18 kg/m2≤BMI≤32 kg/m2，meet the weight range specified in the protocol； * American Society of Anesthesiologists (ASA) grade ⅰ-ⅲ; * Accept hip replacement under general anesthesia; * Within 4 hours after the end of surgery, NRS≥4 in the resting state at any time; * Fully understand and voluntarily participate this trial, and sign the informed consent form;
Exclusion criteria
* Patients with allergy to opioids or any component of the trial drug； * Patients with a history of severe cardiovascular and cerebrovascular diseases, ,and psychiatric disorders; * Last use of opioid or non-opioid analgesics less than 5 half-lives or the duration of drug efficacy prior to randomization; use of drugs with unclear half-lives that may affect analgesic efficacy within 7 days prior to randomization, or last use of drugs affecting analgesic efficacy less than 5 half-lives prior to randomization, as well as Chinese herbal medicines or proprietary Chinese medicines deemed by the investigator as potentially impacting the evaluation of efficacy and safety； * Continuous use of opioid analgesics for more than 7 days for any reason within 30 days prior to screening; * Laboratory test results during the screening period meeting any of the following criteria: 1) Significantly abnormal hematology results; 2) Significantly abnormal prothrombin time test results; 3) Significantly abnormal liver or kidney function; 4) Significantly abnormal fasting blood glucose; * Positive test results during the screening period for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody, or human immunodeficiency virus (HIV) antibody; * A history of drug, drug, and/or alcohol abuse； * Participate in any clinical trail within 30 days; * Pregnant or lactating female subjects； * Subjects of childbearing potential who are unwilling to use contraception throughout the study period or plan to become pregnant within 3 months after the study.； * Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sum of Pain Intensity Differences (SPID) | 48 hours | Sum of Pain Intensity Differences (SPID) of each group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects experiencing nausea | 48 hours | Proportion of subjects experiencing nausea of each group |
| Proportion of subjects experiencing vomit | 48 hours | Proportion of subjects experiencing vomit of each group |
| Sum of Pain Intensity Differences (SPID) in other time frame | 0-8 hours, 0-24 hours, 24-48 hours | Sum of Pain Intensity Differences (SPID) in other time frame |
| Number of times rescue analgesic medications were administered. | 48 hours | Number of times rescue analgesic medications were administered. |
| Total morphine consumption | 48 hours | Total morphine consumption of each group |
Countries
China
Outcome results
None listed