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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Perianal Abscess
• Intervention / Treatment: Other: TCM sitz bath

• Study Type: Interventional
• Enrollment (Estimated): 147
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Putian, Fujian, China, 351100
      • The Affiliated Hospital of Putian University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged between 18 and 75 years old (18 ≤ age ≤ 75);
2. Diagnosed with primary perianal abscess via digital rectal examination, anorectal ultrasound or MRI, and scheduled for incision and drainage or radical surgery;
3. The maximum diameter of the abscess cavity ≥ 2 cm, or with obvious abscess cavity formation;
4. 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;
5. No severe coagulation disorders.

Exclusion Criteria:

1. Complicated with specific infectious diseases such as Crohn's disease and tuberculosis;
2. Unclear source of postoperative pain, i.e., the origin of pain cannot be confirmed or the pain is unrelated to surgery;
3. Presence of definite contraindications, including drug allergy or inability to tolerate any pain management measures adopted in this trial;
4. Pregnant or lactating women;
5. Patients unable to cooperate with the study, such as those with cognitive impairment, history of mental illness, communication barriers and other conditions;
6. Patients with long-term analgesic medication use and established drug tolerance;
7. 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.;
8. Abscess secondary to rectal neoplasms, trauma or iatrogenic injury;
9. Severe postoperative complications (such as massive hemorrhage, sepsis) or concurrent infections at other sites;
10. Patients receiving only non-surgical treatments such as simple needle aspiration of pus.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Other: TCM sitz bath; TCM sitz bath
Experimental: 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	Other: TCM sitz bath; TCM sitz bath

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative urinary retention	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.	24 hours postoperatively
secondary hemorrhage	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.	24 hours postoperatively
perianal edema	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.	within 72 hours postoperatively
assessment of sexual function	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.	assessed preoperatively and at 1 month postoperatively

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Putian University

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: August 2, 2026
• First Posted (Actual): August 4, 2026

Study Record Updates

• Last Update Posted (Actual): August 4, 2026
• Last Update Submitted That Met QC Criteria: August 2, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: PutianU-0013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No