Efficacy of Repeat Dosing of Liposomal Bupivacaine on Postoperative Pain in Patients With Anal Fistula: A Multicenter, Randomized, Open-Label, Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The Sixth Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Hongcheng Lin, MD
lhcheng@mail.sysu.edu.cn
+86 15915815776
Time Frame
Start Date: 2025-07-16
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 408
Treatments
Experimental: 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 postoperatively.
No_intervention: Liposomal Bupivacaine Single-Injection Group
A single dose of liposomal bupivacaine is administered at the conclusion of surgery without adjunctive analgesics.
Related Therapeutic Areas
Sponsors
Leads: Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators: Nanjing Hospital of C. M., Dongguan Hospital of Traditional Chinese Medicine, Xingyi People's Hospital, Maoming People's Hospital, The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, People's Hospital of Xinjiang Uygur Autonomous Region

This content was sourced from clinicaltrials.gov