Actively Recruiting
Efficacy of Repeat Dosing of Liposomal Bupivacaine on Postoperative Pain in Patients With Anal Fistula: A Multicenter, Randomized, Open-Label, Controlled Study
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2025-07-23
408
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
Sixth Affiliated Hospital, Sun Yat-sen University
Lead Sponsor
T
The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Study on Repeat Liposomal Bupivacaine for Post-Surgery Pain in Anal Fistula Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with anal fistula and scheduled to undergo anal fistula surgery
- Aged between 18 and 60 years
- ASA physical status class I-II
- Provides written informed consent after understanding the study protocol
You will not qualify if you...
- Anal fistula caused by specific etiologies such as tuberculosis
- Concurrent acute perianal skin infection
- Poorly controlled diabetes with HbA1c greater than 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 or opioid analgesics within 12 hours before or during surgery
- Concurrent treatment with anticonvulsants, MAO inhibitors, antidepressants, neuromuscular blockers, or anticholinergics within 2 weeks prior to surgery
- Severe hepatic or renal impairment, cardiopulmonary dysfunction, coagulation disorders, or comorbidities contraindicating surgery
- History of severe psychiatric disorders or cognitive impairment
- Sensory disorders 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 or laboratory conditions deemed by investigators to preclude trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 7 days postoperatively
Participants receive a single dose of liposomal bupivacaine at the conclusion of surgery followed by a supplemental dose 72 hours postoperatively to manage postoperative pain.
1 visit at surgery and 1 follow-up visit 72 hours later
Duration - Up to 8 weeks postoperatively
Participants are monitored for safety, wound healing, pain levels, and recovery outcomes following treatment.
Multiple visits at 24, 48, 72, 96, 120, 144, 168 hours; and at 1 week, 2 weeks, 1 month, and 2 months postoperatively
Trial Site Locations
Total: 1 location
1
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
H
Hongcheng Lin, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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