Repeat liposomal bupivacaine for pain after anal fistula surgery.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional protocol tests whether an initial intraoperative dose of liposomal bupivacaine followed by a supplemental dose at 72 hours improves postoperative analgesia after anal fistula repair. Eligible adults (18–60 years, ASA I–II) receive a single dose at the end of surgery without adjunctive analgesics and a planned repeat dose 72 hours postoperatively. Pain scores, rescue analgesic use, wound healing, and length of hospital stay will be recorded during the postoperative period. Patients with active perianal infection, poorly controlled diabetes, recent chemo/radiotherapy, pregnancy/lactation, or hypersensitivity to local anesthetics are excluded.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Anal fistula caused by specific etiologies (e.g., tuberculosis);
* Concurrent acute perianal skin infection;
* Poorly controlled diabetes (HbA1c \>9%);
* Chronic use of corticosteroids;
* History of radiotherapy or chemotherapy within the past 2 weeks;
* Pregnancy or lactation;
* Hypersensitivity to local anesthetics or any component of the investigational drug;
* History of substance abuse, illicit drug use, or alcohol abuse;
* Use or planned use of non-opioid/opioid analgesics within 12 hours before/during surgery;
* Concurrent treatment with anticonvulsants, MAO inhibitors, antidepressants, neuromuscular blockers, or anticholinergics within 2 weeks prior to surgery;
* Severe hepatic/renal impairment, cardiopulmonary dysfunction, coagulation disorders, or comorbidities contraindicating surgery;
* History of severe psychiatric disorders or cognitive impairment;
* Sensory disorders (e.g., hyperalgesia) or preexisting pain interfering with postoperative pain assessment;
* Contraindications to amide-type local anesthetics, opioids, or propofol;
* Participation in investigational drug trials within 90 days prior to enrollment;
* Other clinical/laboratory conditions deemed by investigators to preclude trial participation.

Where it's running

• The Sixth Affiliated Hospital of Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Hongcheng Lin, MD
• Email: lhcheng@mail.sysu.edu.cn
• Phone: +86 15915815776

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Recurrence and Patient-Reported Outcomes after Anal Fistula Surgery

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• Evaluating RD2 Ver.02 for managing anal fistulas

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  Recruiting at 9 sites RedDress Ltd. · Los Angeles, California and 9 other locations · NCT05641844

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.