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New treatment option for Anal Fistula
Official title Study on Repeat Liposomal Bupivacaine for Post-Surgery Pain in Anal Fistula Patients.
ClinicalTrials.gov ID: NCT07081373
What this study is testing
What is A single dose of liposomal bupivacaine is administered at the conclusion of surgery without adjunctive analgesics, followed by a supplemental dose 72 hours postoperatively.?
A single dose of liposomal bupivacaine is administered at the conclusion of surgery without adjunctive analgesics, followed by a supplemental dose 72 hours postoperatively. is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for anal fistula.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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.
You likely can't join if
- 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;
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.