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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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07744594
Enrollment
147
Registered
2026-08-04
Start date
2026-07-30
Completion date
2026-07-30
Last updated
2026-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perianal Abscess

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.

Interventions

OTHERTCM sitz bath

TCM sitz bath

Sponsors

The Affiliated Hospital of Putian University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Numerical Rating Scale,NRSPostoperative days 1, 2, 3, 4, 5, 2 weeks and 1 monthThe Numerical Rating Scale (NRS) for pain assessment ranges from 0 to 10, with higher scores indicating more severe pain and poorer outcomes.
total postoperative analgesic consumptionPostoperative days 1, 2, 3, 4, 5, 2 weeks and 1 monthTotal consumption of analgesics was converted to morphine equivalent daily dose (MEDD) for intergroup comparison.
postoperative quality of life indicatorsat day 3 and month 1 postoperativelyThe 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.

Secondary

MeasureTime frameDescription
postoperative urinary retention24 hours postoperativelyPatients 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.
secondary hemorrhage24 hours postoperativelyActive 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.
perianal edemawithin 72 hours postoperativelyPerianal 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.
assessment of sexual functionassessed preoperatively and at 1 month postoperativelyErectile 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 5, 2026