Efficacy of Repeat Dosing of Liposomal Bupivacaine on Postoperative Pain in Patients With Anal Fistula: A Multicenter, Randomized, Open-Label, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 408
- 试验地点
- 1
- 主要终点
- Area Under the Curve (AUC) of the Numerical Rating Scale (NRS) for pain within 7 Days postoperatively (NRS-AUC0-168h)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Liposomal Bupivacaine Repeat Dosing Group
A single dose of liposomal bupivacaine is administered at the conclusion of surgery without adjunctive analgesics, followed by a supplemental dose 72 hours postoperatively.
干预措施: A single dose of liposomal bupivacaine is administered at the conclusion of surgery without adjunctive analgesics, followed by a supplemental dose 72 hours postoperatively. (Drug)
结局指标
主要结局
Area Under the Curve (AUC) of the Numerical Rating Scale (NRS) for pain within 7 Days postoperatively (NRS-AUC0-168h)
时间窗: 7 days postoperatively
Numerical rating scale, a numerical rating scale where participants select a number from 0 to 10 based on their subjective pain experience. On this scale: 0 represents no pain; 10 represents the most severe pain imaginable.
次要结局
- Numerical Rating Scale (NRS) for pain during wound dressing changes within 7 days postoperatively(7 days postoperatively)
- Number of breakthrough pain episodes and corresponding Numerical Rating Scale (NRS) scores during episodes(7 days postoperatively)
- Wound healing time within 8 weeks postoperatively.(8 weeks postoperatively)
- Area Under the Curve (AUC) of the Numerical Rating Scale (NRS) for pain from 96 to 168 hours postoperatively (NRS-AUC96h-168h)(96 to 168 hours postoperatively)
- Postoperative 7-day cumulative consumption of all analgesic drugs (calculated as morphine equivalents)(7 days postoperatively)
- Postoperative 7-day cumulative consumption of rescue analgesic drugs (calculated as morphine equivalents)(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(14 days after medication were assessed)
- Postoperative heart rate monitoring: Heart rate at 24h, 48h, 72h, 96h, 120h, 144h, and 168h postoperatively.(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.(At 24, 48, 72, 96, 120, 144, and 168 hours postoperatively.)
- SF-12 scores at preoperative, 1 week, 1 month, and 2 months postoperatively.(1 week, 1 month, and 2 months postoperatively.)
- Preoperative, 14-day postoperative, and 1-month postoperative Wexner Incontinence Scores(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.(At 24, 96, and 168 hours postoperatively.)
- Wound healing rate within 8 weeks postoperatively.(8 weeks postoperatively)
- Wound Edema Score within 8 weeks postoperatively.(8 weeks postoperatively)
- Wound granulation tissue color score within 8 weeks postoperatively.(8 weeks postoperatively.)
- Whether the wound is infected within 8 weeks postoperatively.(8 weeks postoperatively.)
- Whether the wound is bleeding within 8 weeks postoperatively.(8 weeks postoperatively.)