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

Official title

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

Overview

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.

Interventions

• Other TCM sitz bath
  TCM sitz bath

Primary outcome measures

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

Secondary outcome measures (4)

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The Affiliated Hospital of Putian University — Putian

Identifiers

NCT: NCT07744594 · PutianU-0013

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗