Clinical trial NCT05394402: A Trial of SHR0410 Injection in Postsurgical Pain Management
Official title: A Phase Ⅱ, Randomized, Double-blind, Placebo-controlled ， Evaluation of the Safety, Efficacy of SHR0410 Injection for Pain Management Following Orthopaedic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Postsurgical Pain
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-27
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SHR0410 Injection compared with placebo
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate the efficacy, safety of SHR0410 Injection and to explore the reasonable of SHR0410 Injection for Pain Management after Orthopaedic Surgery.


Eligibility criteria: Inclusion Criteria:

1. Able and willing to provide a written informed consent；
2. Subjects requiring elective general anesthesia orthopedic surgery；
3. Male or female；
4. Meet the body mass index standard；
5. Conform to the ASA Physical Status Classification；
6. Negative pregnancy test.

Exclusion Criteria:

1. Subjects with a history of myocardial infarction or unstable angina pectoris；
2. Subjects with atrioventricular block or cardiac insufficiency；
3. Subjects with a history of malignancy ；
4. Subjects with a history of stroke；
5. Subjects with a history of mental illness；
6. Subjects with a history of difficult airway；
7. Random blood glucose ≥11.1mmol/L；
8. Subjects with poor blood pressure control；
9. Abnormal values in liver or renal function；
10. Subject with a history of substance abuse and drug abuse；
11. Allergic to drugs that may be used during the study；
12. Use other drugs that affect the analgesic effect before randomization, and the time from the last use to randomization is shorter than 5 half-lives；
13. Participated in clinical trials of other drugs (received experimental drugs)；
14. Other circumstances that the investigator judged inappropriate for participation in this clinical trial.

Primary outcomes:
measure: Usage of Morphine, Post Surgery
timeFrame: 0 hour to 48 hours after IP administration
Secondary outcomes:
measure: Usage of Morphine, Post Surgery at other intervals
timeFrame: 0 hour to 24 hours after IP administration ；24 hours to 48 hours after IP administration
measure: the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、48 、12-24、24-48 Hours under static condition
timeFrame: 48-hours
measure: the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、48 、12-24、24-48 Hours under moving condition
timeFrame: 48-hours
measure: Time to First Dose of Rescue Analgesia
timeFrame: 0 hour to 48 hours after IP administration
measure: Frequency of Doses of Rescue Analgesia Utilized Per Subject， total consumption of morphine Rescue Analgesia Utilized Per Subject
timeFrame: 0 hour to 24 hours after IP administration ；24 hours to 48 hours after IP administration ；0 hour to 48 hours after IP administration
measure: Total press times of PCA pump and effective press times of PCA pump
timeFrame: 0 hour to 24 hours after IP administration ；24 hours to 48 hours after IP administration ；0 hour to 48 hours after IP administration
measure: Proportion of subjects who did not receive Rescue Analgesia
timeFrame: 0 hour to 24 hours after IP administration ；24 hours to 48 hours after IP administration ；0 hour to 48 hours after IP administration
measure: Participant ' satisfaction score for analgesia treatment
timeFrame: 48-hours
measure: Investigator satisfaction score for analgesia treatment
timeFrame: 48-hours
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
Study officials:
References: