postoperative pain
Conditions
Sponsors
LONGHUA Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 65 years (inclusive); 2. American Society of Anesthesiologists (ASA) physical status classification I-II; 3. Patients scheduled for elective complex anal fistula resection under spinal anesthesia; 4. No history of chronic pain; 5. Normal function of major organs and normal coagulation function; 6. Subjects voluntarily participate in the study and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Allergy to the investigational drug or a history of drug dependence/abuse; 2. Severe hepatic or renal dysfunction (ALT/AST > 2 times the upper limit of normal [ULN], or creatinine clearance < 60 mL/min); 3. Severe cardiovascular disease; 4. Pregnancy or breastfeeding; 5. Psychiatric disorders or cognitive impairment; 6. Use of potent opioid analgesics within 1 week before surgery; 7. Use of antibiotics within 1 week before surgery; 8. Patients who are considered by the investigator to be unsuitable for participation in this study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 24-hour resting pain intensity difference time-weighted sum after administration (rSPID24); | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemodynamics: Blood Pressure and Heart Rate;Postoperative pain relief parameters: total amount of pain relief (TOTPAR) and the number of effective PCA presses within 24 hours; | — |
Countries
China
Contacts
Public ContactPeng Sheng
LONGHUA Hospital Shanghai University of Traditional Chinese Medicine
Outcome results
None listed