Study on Repeat Liposomal Bupivacaine for Post-Surgery Pain in Anal Fistula Patients.
Status:
RECRUITING
Trial end date:
2027-06-30
Target enrollment:
Participant gender:
Summary
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.
Phase:
NA
Details
Lead Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators:
Dongguan Hospital of Traditional Chinese Medicine Maoming People's Hospital Nanjing Hospital of C. M. People's Hospital of Xinjiang Uygur Autonomous Region The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine Xingyi People's Hospital