Study on Dynamic Multimodal Analgesia Regimen Integrated With Traditional Chinese and Western Medicine After Perianal Abscess Surgery
2026年8月2日 更新者:The Affiliated Hospital of Putian University
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
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.
研究概览
研究类型
介入性
注册 (估计的)
147
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Fujian
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Putian、Fujian、中国、351100
- The Affiliated Hospital of Putian University
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他:Western Multimodal Analgesia Group
Western multimodal analgesia.
Dynamic whole-course NRS evaluation was performed: baseline measurement preoperatively, regular rest/activity pain checks and breakthrough pain assessment postoperatively, plus follow-up reassessment after discharge.
Stepwise stratified medication was applied alongside non-pharmacological measures including potassium permanganate sitz bath, health education and psychological counseling.
A pain management team adjusted regimens individually via daily ward rounds.
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TCM sitz bath
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实验性的:Integrated Traditional Chinese and Western Medicine Multimodal Analgesia Group
integrated Chinese-Western multimodal analgesia.
All interventions of Group B were adopted, with additional TCM sitz bath and TCM nursing; assessment and Western medicine protocols remained identical to Western Multimodal Analgesia Group
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TCM sitz bath
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Numerical Rating Scale,NRS
大体时间:Postoperative days 1, 2, 3, 4, 5, 2 weeks and 1 month
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The Numerical Rating Scale (NRS) for pain assessment ranges from 0 to 10, with higher scores indicating more severe pain and poorer outcomes.
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Postoperative days 1, 2, 3, 4, 5, 2 weeks and 1 month
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total postoperative analgesic consumption
大体时间:Postoperative days 1, 2, 3, 4, 5, 2 weeks and 1 month
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Total consumption of analgesics was converted to morphine equivalent daily dose (MEDD) for intergroup comparison.
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Postoperative days 1, 2, 3, 4, 5, 2 weeks and 1 month
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postoperative quality of life indicators
大体时间:at day 3 and month 1 postoperatively
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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.
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at day 3 and month 1 postoperatively
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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postoperative urinary retention
大体时间:24 hours postoperatively
|
Patients were placed in the supine position with a moderately full bladder.
The ultrasound probe was positioned above the pubic symphysis, and the anteroposterior, transverse, and longitudinal diameters of the bladder were measured.
The post-void residual urine volume was calculated using the formula: bladder volume (mL) ≈ 0.52 × length × width × height (cm).
A residual volume of <50 mL was considered normal, 50-200 mL indicated mild urinary retention or impaired voiding, and >200 mL was diagnostic of postoperative urinary retention.
Complete inability to void with a bladder volume of >400 mL was defined as acute urinary retention.
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24 hours postoperatively
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secondary hemorrhage
大体时间:24 hours postoperatively
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Active oozing from the surgical wound occurring beyond 24 hours postoperatively, with a blood loss of ≥5 mL, requiring dressing change and continuous compression hemostasis with sterile gauze; secondary suturing is indicated if bleeding cannot be controlled.
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24 hours postoperatively
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perianal edema
大体时间:within 72 hours postoperatively
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Perianal edema was defined as visible significant soft-tissue swelling around the operative site, accompanied by local tenderness, with the edema persisting for more than 72 hours.
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within 72 hours postoperatively
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assessment of sexual function
大体时间:assessed preoperatively and at 1 month postoperatively
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Erectile function in male patients was evaluated using the International Index of Erectile Function-5 (IIEF-5), which has a total score ranging from 5 (minimum) to 25 (maximum), with higher scores denoting better erectile function.
For female patients, sexual function was assessed using the Female Sexual Function Index (FSFI), with total scores ranging from 2 to 36, where a higher score indicates better sexual function.
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assessed preoperatively and at 1 month postoperatively
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月30日
初级完成 (估计的)
2026年7月30日
研究完成 (估计的)
2026年7月30日
研究注册日期
首次提交
2026年6月16日
首先提交符合 QC 标准的
2026年8月2日
首次发布 (实际的)
2026年8月4日
研究记录更新
最后更新发布 (实际的)
2026年8月4日
上次提交的符合 QC 标准的更新
2026年8月2日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他研究编号
- PutianU-0013
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