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

NCT07744594 | Not Yet Recruiting

• 1 other identifier: PutianU-0013
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Perianal Abscess

Outcome Measures

Primary Outcomes (3)

• Numerical Rating Scale，NRS

  The Numerical Rating Scale (NRS) for pain assessment ranges from 0 to 10, with higher scores indicating more severe pain and poorer outcomes.

  Postoperative days 1, 2, 3, 4, 5, 2 weeks and 1 month

• total postoperative analgesic consumption

  Total consumption of analgesics was converted to morphine equivalent daily dose (MEDD) for intergroup comparison.

  Postoperative days 1, 2, 3, 4, 5, 2 weeks and 1 month

• postoperative quality of life indicators

  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.

  at day 3 and month 1 postoperatively

Secondary Outcomes (4)

• 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

Study Arms (2)

Western Multimodal Analgesia Group

OTHER

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.

Other: TCM sitz bath

Integrated Traditional Chinese and Western Medicine Multimodal Analgesia Group

EXPERIMENTAL

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

Other: TCM sitz bath

Interventions

TCM sitz bath OTHER

TCM sitz bath

Integrated Traditional Chinese and Western Medicine Multimodal Analgesia Group; Western Multimodal Analgesia Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Putian University: lead

Study Sites (1)

The Affiliated Hospital of Putian University

Putian, Fujian, 351100, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: August 4, 2026
• Study Start: July 30, 2026
• Primary Completion: July 30, 2026
• Study Completion: July 30, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-08

Locations

CN (1)