Moderate and severe postoperative pain
Conditions
Interventions
Group 2:Administer the medicine 325mg
Group 1:Administer the medicine 500mg
Placebo Group:Placebo
Sponsors
Wuhan Union Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. they have a good understanding of the study and have voluntarily signed an informed consent; 2. Aged 18 to 75 years; 3. American Association of Anesthesiologists (Asa, appendix I) grade I ~ II, and is willing to use a standardized anesthesia protocol during surgery; 4. elective general anesthesia for thoracoabdominal or orthopaedic surgery in a single site, requiring hospitalization after surgery for moderate to severe pain, with postoperative Analgesia lasting more than 24 hours; 5. Body Mass Index (BMI) 18 to 30.
Exclusion criteria
Exclusion criteria: 1. need to undergo other types or parts of surgery at the same time; 2. suffer from significant pain other than the anticipated surgical pain, or they suffer from neurological, psychiatric, or intellectual disorders that do not accurately describe their feelings or understand the pain scale score, or they have other disorders that interfere with the pain assessment; 3. hypersensitivity or known history of allergy to the drug (paracetamol injection, anesthetic) or any adjuvant, aspirin or other non-steroidal anti-inflammatory drug (NSAIDS) prescribed in this study; 4. predicted postoperative hypovolemia or intraoperative bleeding >=400 ML; 5. dehydration due to any cause other than preoperative fasting; 6. having the following conditions that the researchers determined might limit participation in the study: Severe Infections, such as those that are active or clinically poorly controlled; arterial hypertension (systolic blood pressure >=160 MMHG and/or diastolic blood pressure >=105 MMHG in the screening period) that remains uncontrolled even after standard treatment; hypotension (Systolic Blood Pressure =11.1 mmol/l in the screening period); 7. with hepatitis, severe active liver disease, abnormal liver function (ALT and/or AST & GT >1.5 ULN; total bilirubin >1.5 ULN) , abnormal renal function (Serum Creatinine & GT >=1.5 ULN or creatinine clearance =II), or significant abnormalities detected in the electrocardiograms at baseline and during screening as judged by the investigators, or other cardiac dysfunction as judged by the investigators as abnormal and clinically significant; 10. patients with a history of head trauma, intracranial surgery, stroke, arteriovenous malformation, cerebral aneurysm, or with central nervous system organic lesion and disturbance of consciousness within 4 weeks prior to surgery; 11. or 12 hours prior to surgery using paracetamol, or 24 hours prior to surgery using other analgesics, including aspirin, opioids, NSAIDs, other common central/peripheral pain killers, sedatives, muscle relaxant; 12. 2 weeks prior to surgery using Monoamine oxidase inhibitor, Tryptophan, carbamazepine or Valproate, or 3 weeks prior to surgery using other antidepressants (such as 5-hydroxytryptamine or Norepinephrine reuptake inhibitor, tricyclic antidepressants); 13. during the study period, drugs that may affect the study of drug metabolism or toxicity, such as drugs that induce or modulate CYP2E1, antiviral drug Zidovudine, etc.; 14. those with a history of drug abuse or alcoholism defined as drinking more than 14 units of alcohol per week (1 unit of alcohol = 360 mL of beer or 45 mL of spirits with a 40% alcohol content or 150 mL of wine); 15. participated in other clinical trials within 4 weeks prior to surgery; 16. pregnant, lactating women, or women of Reproductive Age who tested positive for pre
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total dose of morphine within 24 hours after Drug Administration was studied for the first time; | — |
Secondary
| Measure | Time frame |
|---|---|
| The total dosage of morphine in 6 H, 6-12 H, 12-24 H, 24-48 H and 48 h before the end of Drug Administration was studied;Area under the pain intensity-time curve (AUC)(0-24h, 6-24h, 12-24h, 24-48h, 48h-pca when the pump is stopped) during rest and movement (cough)(AUC is calculated by the trapezoid method);After 24 hours of treatment, the subjects'overall satisfaction (grade 4:0, not satisfied; 1, General; 2, satisfied; 3, very satisfied); | — |
Countries
China
Contacts
Public ContactXiangdong Chen
Wuhan Union Hospital
Outcome results
None listed