postoperative analgesia
Conditions
Interventions
Phase One:For Anrikefon, the sequential method is used for drug administration, with the dosage for the next subject adjusted based on the analgesic response of the previous subject.
Sponsors
the Second Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, no gender restriction (the ratio of male to female in the first stage is 1:1); 2. BMI 18-27 kg/m²; 3. Acute moderate pain: 24 hours after abdominal surgery, NRS score is >=4 and <=6 (measured within 30 minutes before administration); 4. No analgesic drugs were used within 48 hours before operation; 5. Voluntarily sign the informed consent form and understand and complete the NRS score; 6. Additional requirements for the second phase: Participants must not have participated in the first phase of this study.
Exclusion criteria
Exclusion criteria: 1. Allergy to opioids (especially ? agonists) or morphine; 2. History of central nervous system disease (epilepsy, depression, cognitive impairment); 3. Severe cardiovascular disease (myocardial infarction, heart failure in the past 3 months) or history of hypotension (basal systolic blood pressure <90 mmHg); 4. Severe renal insufficiency; 5. Participated in other clinical trials or had a history of drug abuse (alcoholism, drug abuse) in the past 1 month; 6. Pregnant women, nursing and other special groups; 7. Other circumstances deemed unsuitable for enrollment by the investigator (e.g., severe infections, malignancies).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and comfort;ED??/ED??; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rapid-Onset Analgesia Score; | — |
Countries
China
Contacts
Public ContactLi Jinlu
the Second Affiliated Hospital of Soochow University
Outcome results
None listed