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

NARecruitingINTERVENTIONAL
Enrollment

408

Participants

Timeline

Start Date

July 16, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2027

Conditions
Anal Fistula
Interventions
DRUG

A single dose of liposomal bupivacaine is administered at the conclusion of surgery without adjunctive analgesics, followed by a supplemental dose 72 hours postoperatively.

At surgical closure, a single dose of undiluted liposomal bupivacaine (266 mg/20 mL) is administered without concurrent analgesics. The total 20 mL volume is divided into six equal aliquots (≈3.3 mL each) and infiltrated circumferentially around the incision using a 25-gauge or larger-bore needle. Injections target tissue layers above and below the fascia and within the subcutaneous plane, with frequent aspiration during administration to mitigate intravascular injection risk. Seventy-two hours postoperatively, a repeat dose of undiluted liposomal bupivacaine (266 mg/20 mL) is administered. Prior to infiltration, topical lidocaine cream is applied to the per-incisional skin for ≥20 minutes. The full 20 mL volume is then injected uniformly around the incision via circumferential needle advancement into pericicatricial tissues.

Trial Locations (1)

Unknown

RECRUITING

The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou

All Listed Sponsors
collaborator

The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

UNKNOWN

collaborator

Maoming People's Hospital

OTHER

collaborator

Dongguan Hospital of Traditional Chinese Medicine

OTHER

collaborator

Xingyi People's Hospital

UNKNOWN

collaborator

Nanjing Hospital of C. M.

UNKNOWN

collaborator

People's Hospital of Xinjiang Uygur Autonomous Region

OTHER

lead

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

NCT07081373 - Study on Repeat Liposomal Bupivacaine for Post-Surgery Pain in Anal Fistula Patients. | Biotech Hunter | Biotech Hunter