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

Официальное название

Efficacy of Repeat Dosing of Liposomal Bupivacaine on Postoperative Pain in Patients With Anal Fistula: A Multicenter, Randomized, Open-Label, Controlled Study

Обзор

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. It can occur at any age but is relatively more common in individuals aged 20-40 years, with a higher incidence in males than females. Postoperative wound management is a critical component of the overall treatment for anal fistula patients. Regular postoperative wound care, such as dressing changes, can reduce recurrence rates, alleviate pain, and shorten hospitalization time. However, postoperative pain remains a major challenge in wound management following anal fistula surgery. This is largely attributed to inadequate current postoperative analgesic protocols. With ongoing advancements in local anesthetics, liposomal bupivacaine has been applied for postoperative analgesia. It offers higher bioavailability and a prolonged half-life, providing up to 72 hours of sustained analgesic effect. Given the limitations of existing analgesic strategies for post-anal fistula surgery, developing more effective pain management approaches to reduce postoperative pain holds significant clinical importance. Therefore, the investigators propose that a repeat-dosing strategy based on liposomal bupivacaine may provide superior postoperative pain control for anal fistula patients. To investigate this, the investigators designed a prospective, multicenter, randomized, open-label, controlled clinical trial. This study aims to evaluate the efficacy and safety of repeat-dose liposomal bupivacaine for postoperative analgesia following anal fistula surgery, thereby generating high-level evidence to support its clinical application in this context.

Вмешательства

• Препарат 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

Первичные конечные точки

• Area Under the Curve (AUC) of the Numerical Rating Scale (NRS) for pain within 7 Days postoperatively (NRS-AUC0-168h) [Срок оценки: 7 days postoperatively]

Вторичные конечные точки (12)

• Numerical Rating Scale (NRS) for pain during wound dressing changes within 7 days postoperatively [Срок оценки: 7 days postoperatively]
• Area Under the Curve (AUC) of the Numerical Rating Scale (NRS) for pain from 96 to 168 hours postoperatively (NRS-AUC96h-168h) [Срок оценки: 96 to 168 hours postoperatively]
• Number of breakthrough pain episodes and corresponding Numerical Rating Scale (NRS) scores during episodes [Срок оценки: 7 days postoperatively]
• Postoperative 7-day cumulative consumption of all analgesic drugs (calculated as morphine equivalents) [Срок оценки: 7 days postoperatively]
• Postoperative 7-day cumulative consumption of rescue analgesic drugs (calculated as morphine equivalents) [Срок оценки: 7 days postoperatively]
• Safety (including incidence of postoperative adverse events and serious adverse events): Adverse events and serious adverse events occurring within 14 days after medication were assessed [Срок оценки: 14 days after medication were assessed]
• Postoperative heart rate monitoring: Heart rate at 24h, 48h, 72h, 96h, 120h, 144h, and 168h postoperatively. [Срок оценки: At 24, 48, 72, 96, 120, 144, and 168 hours postoperatively.]
• Postoperative blood pressure monitoring: systolic blood pressure, and diastolic blood pressure at 24h, 48h, 72h, 96h, 120h, 144h, and 168h postoperatively. [Срок оценки: At 24, 48, 72, 96, 120, 144, and 168 hours postoperatively.]
• SF-12 scores at preoperative, 1 week, 1 month, and 2 months postoperatively. [Срок оценки: 1 week, 1 month, and 2 months postoperatively.]
• Preoperative, 14-day postoperative, and 1-month postoperative Wexner Incontinence Scores [Срок оценки: Prior to surgery; 14 days after surgery; 1 month postoperatively.]
• Analgesia satisfaction: Postoperative analgesic satisfaction was assessed using a 5-point categorical scale at 24h, 96h, and 168h postoperatively. [Срок оценки: At 24, 96, and 168 hours postoperatively.]
• Wound healing rate within 8 weeks postoperatively. [Срок оценки: 8 weeks postoperatively]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Sixth Affiliated Hospital of Sun Yat-sen University — Гуанчжоу

Идентификаторы

NCT: NCT07081373 · 2025ZSLYEC-365

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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