Pain
Conditions
Interventions
Phase ? placebo group:Placebo was administered orally every 6 hours for a total of 8 times
Sponsors
The Third Xiangya Hospital of Central South University, Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old =4 at rest; (3) The investigator assessed that the trial participants could swallow the investigational product smoothly.
Exclusion criteria
Exclusion criteria: 1. Previous surgery at the same site that may affect the pain perception at the surgical site as assessed by the researcher; 2. Paresthesia or other pain that may affect the postoperative pain evaluation or scale evaluation by the investigator; 3. Patients with neuropsychiatric disorders, such as depression, anxiety, memory and cognitive impairment, severe sleep disorders, and previous suicidal behavior or suicidal tendency, which may affect postoperative pain evaluation or scale evaluation; 4. Any history of gastrointestinal disorders assessed by the investigator that may affect oral drug absorption; 5. QTcF >=450 ms in men and >=470 ms in women (corrected by Fridericia's method), unstable angina pectoris, myocardial infarction, severe arrhythmia (such as ? degree atrioventricular block), NYHA class >=?, or recurrent asthma, etc. 6. Poorly controlled hypertension defined as systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg (except perioperative period); 7. Sleep apnea syndrome or difficult airway as assessed by the investigator; 8. Patients with high bleeding risk who are not suitable for participation in the trial according to the evaluation of the investigator, including congenital bleeding diseases (such as hemophilia), abnormal platelet function (such as idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, congenital abnormal platelet function), active bleeding, etc. 9. Known allergic to any component of the trial intervention drug, allergic to anesthetic/analgesic/antiemetic drugs used during the perioperative period (from the induction of anesthesia to the completion of surgery), or previous allergic history of >=3 substances; 10. Participants with a history of motion sickness or previous perioperative vomiting that was judged by the investigator to be likely to develop postoperative nausea and vomiting; 11. The interval between randomization and the last use of a protocol-specified contraindicated drug was less than five half-lives (indefinite half-lives, with 7-day washout) of the drug and could affect the evaluation of the trial drug, as assessed by the investigator; 12. Before surgery, abnormal laboratory tests: Platelet count 2.5 × upper limit of normal value, total bilirubin (TBil) > 1.5 × upper limit of normal value; Estimated glomerular filtration rate (eGFR) 14 units of alcohol per week; 1 unit =360 mL of 5% beer or 45 mL of 40% liquor or 150 mL of 12% wine) or substance abuse in the 2 years before screening; 15. Pregnant or lactating women (within 1 year after delivery); 16. Trial participants of childbearing potential who had plans to give birth/cryopreservation or sperm/egg donation within 6 months after signing informed consent until the last dose, or who did not agree to an effective contraceptive method (complete abstinence, barrier method, contraceptive pill, intrauterine device, or sterilization); 17. Participants who had participated in other drug or medical device trials or were participating in other clinical trials an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time-weighted summed pain intensity at rest differences over 48 h (SPID0-48 h) after the first dose ; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time-weighted summed pain intensity at rest differences over 24 h (SPID0-24 h) after the first dose ;The proportion of participants with >=30%, >=50% and >=70% reduction in resting-state numerical rating scale (NRS) at 24h and 48h after the first dose was compared with the baseline.;Time for NRS to decrease >=1 and >=2 points from baseline after the first dose.;The time-weighted summed pain intensity during movement differences from 8h to 24h (SPIDm8-24h) after the first dose , SPIDm8-48h.;The time to first use of rescue therapy, the total number of times used, the cumulative amount used, and the proportion of participants who used rescue therapy within 48 hours after the first dose were analyzed.;The time to response (time to onset of participant perceived pain relief and time to substantial participant perceived improvement in pain) was assessed with the use of a double-stopwatch.;NRS Pain score; | — |
Countries
China
Contacts
Public ContactSaiying Wang/ Mengchang Yang
The Third Xiangya Hospital of Central South University, Sichuan Provincial People's Hospital
Outcome results
None listed