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

Anal Fistula refers to an abnormal infectious fistula tract between the anorectum and the perianal skin. The prevalence of anal fistula is approximately 8.6 cases per 100,000 individuals. It can occur at any age but is relatively more common in individuals aged 20-40 years, with a higher incidence in males than females. Postoperative wound management is a critical component of the overall treatment for anal fistula patients. Regular postoperative wound care, such as dressing changes, can reduce recurrence rates, alleviate pain, and shorten hospitalization time. However, postoperative pain remains a major challenge in wound management following anal fistula surgery. This is largely attributed to inadequate current postoperative analgesic protocols. With ongoing advancements in local anesthetics, liposomal bupivacaine has been applied for postoperative analgesia. It offers higher bioavailability and a prolonged half-life, providing up to 72 hours of sustained analgesic effect. Given the limitations of existing analgesic strategies for post-anal fistula surgery, developing more effective pain management approaches to reduce postoperative pain holds significant clinical importance. Therefore, the investigators propose that a repeat-dosing strategy based on liposomal bupivacaine may provide superior postoperative pain control for anal fistula patients. To investigate this, the investigators designed a prospective, multicenter, randomized, open-label, controlled clinical trial. This study aims to evaluate the efficacy and safety of repeat-dose liposomal bupivacaine for postoperative analgesia following anal fistula surgery, thereby generating high-level evidence to support its clinical application in this context.

NCT Number	NCT07081373
Lead Sponsor	Sixth Affiliated Hospital, Sun Yat-sen University Collaborators: First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Maoming People's Hospital, Dongguan Hospital of Traditional Chinese Medicine, Xingyi People's Hospital, Nanjing Hospital of C. M., People's Hospital of Xinjiang Uygur Autonomous Region
Conditions	Anal Fistula
Enrollment	408 participants
Start Date	2025-07-16
Primary Completion	2026-06-30 (estimated)
Study Completion	2027-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-07-23