postoperative analgesia
Conditions
Interventions
Low dose oxelidine group:Analgesic dose
High dose oxelidine group:Analgesic dose
Hydromorphone group:Analgesic dose
Sponsors
The Fourth Affiliated Hospital of Zhejiang University Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1)Age >18 years old, ASA grade I-III. 2) Plan to undergo elective orthopedic surgery under general anesthesia.
Exclusion criteria
Exclusion criteria: 1) Accept any clinical trial within 28 days before surgery 2) ASA grade >III 3) Patients with advanced tumor with ascites or extensive metastasis, or undergoing systemic chemotherapy or radiotherapy, or requiring postoperative thermoperfusion; 4) Other acute and chronic pain conditions are present 5) Body mass index (BMI) 30 kg/m2 6) Pregnant or lactating women, or patients who have a positive blood (or urine) pregnancy test at the time of screening or on the day of surgery, or who plan to become pregnant 7) Allergy to opioids 8) Allergic to or contraindicated with anesthesia, auxiliary analgesia, remedial painkillers, emergency antiemetic drugs, and antibiotics used in the study 9) Sleep apnea syndrome 10) Long-term opioid treatment, defined as receiving more than 15mg of morphine equivalent units per day more than 3 days per week for a period longer than 1 month, within the 12 months prior to surgery 11) Use of any pain medication for 5 half-lives before surgery (or within 48 hours if half-life is unknown); Or long-term nonsteroidal anti-inflammatory drug (NSAID) treatment, defined as more than 2 consecutive weeks of daily use of NSAID in the 6 months prior to surgery 12) Patients with mental and nervous system diseases (such as epilepsy, depression, schizophrenia, etc.), gastrointestinal obstruction, chronic obstructive pulmonary disease or pulmonary heart disease, cardiovascular disease (heart rate below 50 beats/min, blood pressure below 90/60 mmHg or atrioventricular block of ? degree and above ? degree) 13) Oral, inhalation, or parenteral corticosteroids were used within 3 months before surgery (nasal corticosteroids and limited topical corticosteroids were allowed at the discretion of the investigator) 14) Abnormal liver function during screening (total bilirubin > 2× upper limit of normal ULN, aspartate aminotransferase [AST]=1.5×ULN and alanine aminotransferase [ALT]=1.5×ULN) 15) Abnormal renal function (creatinine > 1×ULN) during screening 16) Positive antibody to human immunodeficiency virus, hepatitis B virus surface antigen or hepatitis C virus antibody or treponema pallidum antibody at screening;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve of pain score at rest 0-72 hours after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| The total amount of opioid relief analgesics was converted into morphine 0-72 hours after operation in the three groups;PCIA as a remedial analgesic press time;Area under the curve of pain scores during 0-72 hours of exercise;The total number of PCA pump presses and the number of effective pre; | — |
Countries
China
Contacts
Public ContactDongmei Ma
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed