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

2 augusti 2026 uppdaterad av: The Affiliated Hospital of Putian University

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

147

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: 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.
TCM sitz bath
Experimentell: 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
TCM sitz bath

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Numerical Rating Scale,NRS
Tidsram: Postoperative days 1, 2, 3, 4, 5, 2 weeks and 1 month
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
Tidsram: Postoperative days 1, 2, 3, 4, 5, 2 weeks and 1 month
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
Tidsram: at day 3 and month 1 postoperatively
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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
postoperative urinary retention
Tidsram: 24 hours postoperatively
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
Tidsram: 24 hours postoperatively
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
Tidsram: within 72 hours postoperatively
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
Tidsram: assessed preoperatively and at 1 month postoperatively
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

Samarbetspartners och utredare

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

30 juli 2026

Primärt slutförande (Beräknad)

30 juli 2026

Avslutad studie (Beräknad)

30 juli 2026

Studieregistreringsdatum

Först inskickad

16 juni 2026

Först inskickad som uppfyllde QC-kriterierna

2 augusti 2026

Första postat (Faktisk)

4 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • PutianU-0013

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