Pain
Conditions
Interventions
Low dose group*:Experimental drugs
Medium dose group*:Experimental drugs
High dose group*:Experimental drugs
Low dose control group:Placebo
Medium dose control group*:Placebo
High dose control group*:Placebo
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old and =30 hours after surgery; 4. The physical condition of patients before anesthesia and the risk of surgery are classified according to the American Society of Anesthesiologists (ASA)Grading standard I~III; 5. The subjects voluntarily joined the study, signed the informed consent, and were able to abide by the visits and related visits stipulated by the protocol Close the program.
Exclusion criteria
Exclusion criteria: 1. Major surgery or serious trauma within 3 months prior to screening; 2. Opioid analgesics for any reason for more than 10 consecutive days within 3 months prior to screening, before randomization use of analgesics such as opioid or non-opioid for less than 5 half-lives of the drug or the pharmacotherapy duration of effect (calculated by the longest time), or taking drugs that affect the analgesic effect within 14 days before randomization. 3. Known allergy to opioids, including those used during and after surgery, and allergic to ondansetron; 4. There is a clear history of neurological or mental disorders; 5. Known to have respiratory depression, (pulmonary) airway obstruction or tissue hypoxia, history of asthma; 6. Patients who need nerve block or local infiltration anesthesia; 7. Patients who need postoperative analgesia pump placement; 8. Patients with pain score >= 3 points during the screening period; 9. Experience severe persistent diarrhea, vomiting, nausea and/or dizziness during the screening period; 10. Have a history of drug abuse; 11. Grade II and above cardiac dysfunction (NYHA criteria), ischemic heart disease (such as myocardial infarction or angina pectoris),clinically significant supraventricular or ventricular arrhythmias, significant QTc interval prolongation, etc.The researchers believe there are additional risks to the investigational drug. 12. uncontrolled hypertension, and judged by the researchers to have clinical significance; 13. Laboratory tests: (1) Liver function: Serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2.5 times*upper limit of normal reference value (ULN), and/or total bilirubin > 1.5*ULN, and study the investigator judges that it has clinical significance; (2) Renal function: urea (Urea)>1.5*ULN and/or serum creatinine (Cr)>1.5*ULN, and/or serum Creatinine clearance < lower limit of normal (LLN), and the investigator judges it to be clinically significant; (3) Patients with clinically significant anemia: hemoglobin (Hb) <90 g/L; 14. Oxygen saturation < 95% without oxygen inhalation; 15. Virology test: positive for human immunodeficiency virus (HIV) antibody, syphilis antibody, hepatitis B or C; 16. Women of childbearing age, pregnant and lactating women or subjects (and their partners) have family planning during the study period and within 3 months after the end of the study, reluctance to use appropriate contraceptive measures (eg complete abstinence, contraceptive ring, partner ligation and other measures); 17. Participated in other clinical trials and received experimental drugs within 30 days before screening; 18. The investigator judges that the subjects may have other factors that may affect the study, resulting in the inability to complete the trial medication and follow up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The summed pain intensity differences (SPID) within 24 hours after the end of the first postoperative drug administration in patients undergoing pelvioscopy or laparoscopic surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| The total amount of morphine within 24 hours after the end of the first dose after surgery;The ratio between the area on the curve of summed pain intensity difference (SPID) and morphine within 24 hours after the first administration ratio of dosage; | — |
Countries
China
Contacts
Public ContactLiu jin, Li Fangzhou
West China Hospital of Sichuan University
Outcome results
None listed