Clinical Application of Dynamic Multimodal Analgesia Regimen After Perianal Abscess Surgery

Обзор

This study aims to investigate whether the full-course multimodal analgesia regimen based on dynamic assessment (including the integrated traditional Chinese and Western medicine mode) can alleviate postoperative pain, reduce opioid dosage, and decrease the incidence of complications in patients with perianal abscess. It also intends to verify the clinical advantages of the integrated traditional Chinese and Western medicine multimodal regimen and establish a promotable standardized pain management pathway. A total of 135 eligible patients will be enrolled and divided into three groups in a 1:1:1 ratio using a single-center, prospective, randomized parallel-controlled design. The specific grouping and intervention methods are as follows: ① Control Group (Group A): Adopts the traditional analgesic mode, where NRS assessment and intervention are conducted only when the patient actively complains of pain (medication administered for scores ≥4 points) without preemptive medication. Medications refer to conventional schemes (e.g., flurbiprofen, diclofenac sodium, etc.). ② Western Medicine Multimodal Analgesia Group (Group B): Implements dynamic assessment + stepwise medication intervention + non-pharmacological auxiliary measures. Baseline NRS score is collected 24 hours before surgery; pain at rest and during activity is assessed at fixed time points after surgery; NSAIDs, opioids, and other medications are administered as needed, combined with potassium permanganate sitz bath, health education, etc. ③ Integrated Traditional Chinese and Western Medicine Multimodal Analgesia Group (Group C): Integrates characteristic traditional Chinese medicine nursing interventions (including auricular point pressing, wrist-ankle acupuncture, traditional Chinese medicine sitz bath, etc.) on the basis of Group B's intervention. To evaluate the clinical efficacy of the dynamic multimodal analgesia regimen, this study will compare the following indicators among the three groups: NRS pain scores on postoperative days 1, 2, 3, 4, 5, as well as 2 weeks and 1 month after discharge; total postoperative analgesic consumption converted to morphine equivalent dose (MEDD); quality of life score assessed by the SF-36 scale; incidence of complications (such as urinary retention, secondary hemorrhage, etc.); sexual function recovery (assessed by the IIEF-5 scale for males and the FSFI scale for females); and patient satisfaction and compliance. The primary research hypothesis is: compared with conventional analgesia and western medicine-only multimodal analgesia, the integrated traditional Chinese and Western medicine multimodal analgesia regimen can significantly reduce patients' postoperative pain scores, decrease opioid dosage, improve quality of life and patient satisfaction, lower the incidence of complications, and enhance patients' sexual function recovery.

Вмешательства

• Препарат the traditional analgesic mode
  Adopt the traditional analgesic mode: conduct NRS assessment and intervention only when the patient takes the initiative to complain of pain, without fixed assessment time points. Intervene when the pain score is ≥4 points, and no prophylactic medication is administered. Medication use refers to the conventional plan (e.g., flurbiprofen injection, diclofenac sodium capsules, etc.).
• Поведенческое Western Medicine Multimodal Analgesia
  Collect baseline NRS score 24 hours before surgery. After surgery, assess NRS in resting and active states at fixed daily time points (e.g., 08:00, 16:00), and conduct on-demand assessment for breakthrough pain. Reassess during outpatient follow-up at 2 weeks and 1 month after discharge. 1. Stepwise medication intervention: Administer medications in a stepwise manner based on NRS score. For scores ≤3 points, prioritize non-pharmacological interventions; for scores ≥4 points, initiate NSAIDs, ac
• Поведенческое Integrated Traditional Chinese and Western Medicine Multimodal Analgesia
  On the basis of western medicine multimodal analgesia, integrate characteristic traditional Chinese medicine nursing interventions, such as auricular point pressing, wrist-ankle acupuncture, traditional Chinese medicine sitz bath, etc.

Первичные конечные точки

• Postoperative pain score [Срок оценки: From enrollment to 1 month after discharge]

Вторичные конечные точки (1)

• Secondary Efficacy Indicators [Срок оценки: From enrollment to 1 month after discharge]

Критерии участия

Критерии включения

• Diagnosed with primary perianal abscess by clinical examinations (digital rectal examination, ultrasound, or MRI) and undergoing incision and drainage or radical surgical treatment;
• Abscess diameter ≥ 2 cm or accompanied by obvious abscess cavity formation;
• Patients are willing and able to participate in the pain management plan, understand the importance of pain management, and actively cooperate;
• No severe coagulation disorders.

Критерии исключения

• Complicated with specific infectious diseases such as Crohn's disease or tuberculosis;
• Unclear source of postoperative pain (i.e., the patient's pain is uncertain or unrelated to the surgery);
• Having definite contraindications, including drug allergies or inability to accept certain pain management methods adopted in the study;
• Pregnant or lactating women;
• Patients unable to cooperate with the study, such as those with cognitive impairment, history of mental illness, or communication difficulties;
• Patients with long-term use of analgesic drugs and developed drug tolerance;
• Complicated with uncontrolled cardiovascular and cerebrovascular diseases (NYHA cardiac function Class Ⅲ-Ⅳ), liver or kidney insufficiency (Child-Pugh Class C or eGFR < 30 ml/min/1.73m²), etc.;
• Abscess secondary to rectal tumors, trauma, or iatrogenic injury;
• Postoperative occurrence of severe complications (e.g., massive hemorrhage, sepsis) or combined infection in other parts;
• Patients receiving only non-surgical treatments such as simple puncture and 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

Другое

Центры проведения

Китай · 1 центр

• Affiliated Hospital of Putian University — Putian

Идентификаторы

NCT: NCT07358065 · PutianU-014

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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