Study Evaluating Repeat-Dose Liposomal Bupivacaine for Pain Relief After Anal Fistula Surgery in Adults

What this Trial Is About

Anal fistula is an abnormal infectious tract between the anorectum and perianal skin, affecting about 8.6 people per 100,000. It is more common in males aged 20 to 40. Effective postoperative wound management is crucial to reduce pain and recurrence after surgery, but current pain control methods are insufficient. This study evaluates the safety and effectiveness of repeat dosing with liposomal bupivacaine, a local anesthetic that may provide longer-lasting pain relief after anal fistula surgery. Participants receive either a single dose of liposomal bupivacaine at the end of surgery or the same initial dose plus a supplemental dose 72 hours later. The drug is injected around the surgical incision in divided doses targeting specific tissue layers. Topical lidocaine cream is applied before the second injection to reduce discomfort. The study is randomized, open-label, and conducted at multiple centers to compare these two approaches. During the 7-day postoperative period, researchers will measure pain levels using a numerical rating scale and assess breakthrough pain episodes. They will also monitor analgesic drug use, vital signs, wound healing progress over 8 weeks, and patient satisfaction with pain control. Safety assessments include tracking adverse events for 14 days after treatment. Additional evaluations involve quality of life scores and incontinence assessments before and after surgery, with the total follow-up lasting up to two months.

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