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

N/ANot Yet RecruitingNCT07744594

The Affiliated Hospital of Putian University147 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

147

Conditions

Perianal Abscess

Interventions

TCM sitz bath

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: at day 3 and month 1 postoperatively

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: assessed preoperatively and at 1 month postoperatively