- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07744594
Study on Dynamic Multimodal Analgesia Regimen Integrated With Traditional Chinese and Western Medicine After Perianal Abscess Surgery
2. august 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
147
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Fujian
-
Putian, Fujian, Kina, 351100
- The Affiliated Hospital of Putian University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: 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
|
|
Eksperimentel: 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
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TCM sitz bath
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Numerical Rating Scale,NRS
Tidsramme: 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.
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Postoperative days 1, 2, 3, 4, 5, 2 weeks and 1 month
|
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total postoperative analgesic consumption
Tidsramme: 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.
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Postoperative days 1, 2, 3, 4, 5, 2 weeks and 1 month
|
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postoperative quality of life indicators
Tidsramme: at day 3 and month 1 postoperatively
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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.
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at day 3 and month 1 postoperatively
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
postoperative urinary retention
Tidsramme: 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.
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24 hours postoperatively
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secondary hemorrhage
Tidsramme: 24 hours postoperatively
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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.
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24 hours postoperatively
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perianal edema
Tidsramme: within 72 hours postoperatively
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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.
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within 72 hours postoperatively
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assessment of sexual function
Tidsramme: 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.
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assessed preoperatively and at 1 month postoperatively
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
30. juli 2026
Primær færdiggørelse (Anslået)
30. juli 2026
Studieafslutning (Anslået)
30. juli 2026
Datoer for studieregistrering
Først indsendt
16. juni 2026
Først indsendt, der opfyldte QC-kriterier
2. august 2026
Først opslået (Faktiske)
4. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- PutianU-0013
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