Anal Fistula
Conditions
Interventions
Liposomal Bupivacaine Repeat Dosing Group:A single dose of liposomal bupivacaine is administered at the conclusion of surgery without adjunctive analgesics, followed by a supplemental dose 72 hours po
Liposomal Bupivacaine Single-Injection Group:A single dose of liposomal bupivacaine is administered at the conclusion of surgery without adjunctive analgesics.
Sponsors
The Sixth Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with anal fistula and scheduled to undergo anal fistula surgery; 2. Aged between 18 and 60 years; 3. ASA (American Society of Anesthesiologists) physical status class I-II; 4. Patient provides written informed consent after understanding the study protocol.
Exclusion criteria
Exclusion criteria: 1. Anal fistula caused by specific etiologies (e.g., tuberculosis); 2. Concurrent acute perianal skin infection; 3. Poorly controlled diabetes (HbA1c >9%); 4. Chronic use of corticosteroids; 5. History of radiotherapy or chemotherapy within the past 2 weeks; 6. Pregnancy or lactation; 7. Hypersensitivity to local anesthetics or any component of the investigational drug; 8. History of substance abuse, illicit drug use, or alcohol abuse; 9. Use or planned use of non-opioid/opioid analgesics within 12 hours before/during surgery; 10. Concurrent treatment with anticonvulsants, MAO inhibitors, antidepressants, neuromuscular blockers, or anticholinergics within 2 weeks prior to surgery; 11. Severe hepatic/renal impairment, cardiopulmonary dysfunction, coagulation disorders, or comorbidities contraindicating surgery; 12. History of severe psychiatric disorders or cognitive impairment; 13. Sensory disorders (e.g., hyperalgesia) or preexisting pain interfering with postoperative pain assessment; 14. Contraindications to amide-type local anesthetics, opioids, or propofol; 15. Participation in investigational drug trials within 90 days prior to enrollment; 16. Other clinical/laboratory conditions deemed by investigators to preclude trial participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Curve (AUC) of the Numerical Rating Scale (NRS) for pain within 7 Days postoperatively (NRS-AUC0-168h); | — |
Secondary
| Measure | Time frame |
|---|---|
| Numerical Rating Scale (NRS) for pain during wound dressing changes within 7 days postoperatively;Pain numerical rating scale (NRS) area under the curve (AUC) from 4 to 7 days after surgery (NRS-AUC96h-168h);Number of breakthrough pain episodes and corresponding Numerical Rating Scale (NRS) scores during episodes;Postoperative 7-day cumulative consumption of all analgesic drugs (calculated as morphine equivalents);Postoperative 7-day cumulative consumption of rescue analgesic drugs (calculated as morphine equivalents);Safety (including incidence of postoperative adverse events and serious adverse events): Adverse events and serious adverse events occurring within 14 days after medication were assessed;Hemodynamic indicators: heart rate, systolic blood pressure, diastolic blood pressure;SF-12 scores at preoperative;Postoperative 8-week wound healing outcomes: Healing rate, healing time, edema score, granulation tissue color score, presence of infection, presence of bleeding, and other relevant parameters.;Wexner Incontinence Scores;Analgesia satisfaction: Postoperative analgesic satisfaction was assessed using ; | — |
Countries
China
Contacts
Public ContactHongcheng Lin
The Sixth Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed