Study on Repeat Liposomal Bupivacaine for Post-Surgery Pain in Anal Fistula Patients.

Launched by SIXTH AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · Jul 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to manage pain after surgery for anal fistula, which is a small tunnel that can form between the inside of the anus and the skin around it. Surgery is often needed to treat this condition, but pain after the operation can be hard to control with current treatments. The researchers are testing whether giving a special pain medicine called liposomal bupivacaine more than once after surgery can help reduce pain better and for a longer time. This medicine is designed to slowly release pain relief over several days, potentially making recovery more comfortable.

Adults between 18 and 60 years old who have been diagnosed with anal fistula and are scheduled for surgery may be eligible to join the study. Participants will need to be generally healthy without serious medical issues that could affect surgery or pain management. During the trial, patients will receive repeat doses of the pain medicine after their surgery, and the researchers will closely monitor how well it controls pain and whether it is safe. This study aims to find better ways to help patients recover with less discomfort after anal fistula surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosed with anal fistula and scheduled to undergo anal fistula surgery;
• • Aged between 18 and 60 years;
• • ASA (American Society of Anesthesiologists) physical status class I-II;
• • Patient provides written informed consent after understanding the study protocol.
• Exclusion Criteria:
• • Anal fistula caused by specific etiologies (e.g., tuberculosis);
• • Concurrent acute perianal skin infection;
• • Poorly controlled diabetes (HbA1c \>9%);
• • Chronic use of corticosteroids;
• • History of radiotherapy or chemotherapy within the past 2 weeks;
• • Pregnancy or lactation;
• • Hypersensitivity to local anesthetics or any component of the investigational drug;
• • History of substance abuse, illicit drug use, or alcohol abuse;
• • Use or planned use of non-opioid/opioid analgesics within 12 hours before/during surgery;
• • Concurrent treatment with anticonvulsants, MAO inhibitors, antidepressants, neuromuscular blockers, or anticholinergics within 2 weeks prior to surgery;
• • Severe hepatic/renal impairment, cardiopulmonary dysfunction, coagulation disorders, or comorbidities contraindicating surgery;
• • History of severe psychiatric disorders or cognitive impairment;
• • Sensory disorders (e.g., hyperalgesia) or preexisting pain interfering with postoperative pain assessment;
• • Contraindications to amide-type local anesthetics, opioids, or propofol;
• • Participation in investigational drug trials within 90 days prior to enrollment;
• • Other clinical/laboratory conditions deemed by investigators to preclude trial participation.