Study on Dynamic Multimodal Analgesia Regimen Integrated With Traditional Chinese and Western Medicine After Perianal Abscess Surgery: A Single-Center, Prospective, Open-Label Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Numerical Rating Scale，NRS
研究概览
简要总结
Background:Perianal abscess is a common acute anorectal pyogenic disease (8%-25% of anorectal illnesses), mainly seen in men aged 20-40. Over 90% suffer severe postoperative pain, impairing healing, triggering anxiety or sepsis and raising medical loads. Western multimodal analgesia eases pain yet causes dependence and side effects. TCM sitz baths clear heat, reduce swelling and promote recovery. Few personalized combined protocols are available, and integrated Chinese-Western synergies are insufficiently exploited. This optimized integrated intervention guides postoperative pain nursing.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 75 years old (18 ≤ age ≤ 75);
- •Diagnosed with primary perianal abscess via digital rectal examination, anorectal ultrasound or MRI, and scheduled for incision and drainage or radical surgery;
- •The maximum diameter of the abscess cavity ≥ 2 cm, or with obvious abscess cavity formation;
- •Patients are willing and capable of participating in the pain management protocol, fully understand the significance of pain management, and can actively cooperate with study procedures;
- •No severe coagulation disorders.
排除标准
- •Complicated with specific infectious diseases such as Crohn's disease and tuberculosis;
- •Unclear source of postoperative pain, i.e., the origin of pain cannot be confirmed or the pain is unrelated to surgery;
- •Presence of definite contraindications, including drug allergy or inability to tolerate any pain management measures adopted in this trial;
- •Pregnant or lactating women;
- •Patients unable to cooperate with the study, such as those with cognitive impairment, history of mental illness, communication barriers and other conditions;
- •Patients with long-term analgesic medication use and established drug tolerance;
- •Complicated with uncontrolled cardiovascular and cerebrovascular diseases (NYHA cardiac function class Ⅲ-Ⅳ), hepatic and renal insufficiency (Child-Pugh class C or eGFR < 30 mL/min/1.73 m²), etc.;
- •Abscess secondary to rectal neoplasms, trauma or iatrogenic injury;
- •Severe postoperative complications (such as massive hemorrhage, sepsis) or concurrent infections at other sites;
- •Patients receiving only non-surgical treatments such as simple needle aspiration of pus.
结局指标
主要结局
Numerical Rating Scale，NRS
时间窗: Postoperative days 1, 2, 3, 4, 5, 2 weeks and 1 month
The Numerical Rating Scale (NRS) for pain assessment ranges from 0 to 10, with higher scores indicating more severe pain and poorer outcomes.
total postoperative analgesic consumption
时间窗: Postoperative days 1, 2, 3, 4, 5, 2 weeks and 1 month
Total consumption of analgesics was converted to morphine equivalent daily dose (MEDD) for intergroup comparison.
postoperative quality of life indicators
时间窗: at day 3 and month 1 postoperatively
The Short-Form 36 (SF-36) Health Survey was employed to evaluate quality of life, with each domain scored from 0 (minimum) to 100 (maximum), and higher scores reflecting more favorable health status and better quality of life.
次要结局
- postoperative urinary retention(24 hours postoperatively)
- secondary hemorrhage(24 hours postoperatively)
- perianal edema(within 72 hours postoperatively)
- assessment of sexual function(assessed preoperatively and at 1 month postoperatively)