Study on Dynamic Multimodal Analgesia Regimen Integrated With Traditional Chinese and Western Medicine After Perianal Abscess Surgery

Официальное название

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

Обзор

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.

Вмешательства

• Другое TCM sitz bath
  TCM sitz bath

Первичные конечные точки

• Numerical Rating Scale，NRS [Срок оценки: Postoperative days 1, 2, 3, 4, 5, 2 weeks and 1 month]
• total postoperative analgesic consumption [Срок оценки: Postoperative days 1, 2, 3, 4, 5, 2 weeks and 1 month]
• postoperative quality of life indicators [Срок оценки: at day 3 and month 1 postoperatively]

Вторичные конечные точки (4)

• postoperative urinary retention [Срок оценки: 24 hours postoperatively]
• secondary hemorrhage [Срок оценки: 24 hours postoperatively]
• perianal edema [Срок оценки: within 72 hours postoperatively]
• assessment of sexual function [Срок оценки: assessed preoperatively and at 1 month postoperatively]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

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 Affiliated Hospital of Putian University — Putian

Идентификаторы

NCT: NCT07744594 · PutianU-0013

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗