- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07744594
Study on Dynamic Multimodal Analgesia Regimen Integrated With Traditional Chinese and Western Medicine After Perianal Abscess Surgery
2. August 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
147
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Fujian
-
Putian, Fujian, China, 351100
- The Affiliated Hospital of Putian University
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Sonstiges: 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
|
|
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
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TCM sitz bath
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Numerical Rating Scale,NRS
Zeitfenster: 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
|
|
total postoperative analgesic consumption
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
postoperative urinary retention
Zeitfenster: 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
Zeitfenster: 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.
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24 hours postoperatively
|
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perianal edema
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
30. Juli 2026
Primärer Abschluss (Geschätzt)
30. Juli 2026
Studienabschluss (Geschätzt)
30. Juli 2026
Studienanmeldedaten
Zuerst eingereicht
16. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
2. August 2026
Zuerst gepostet (Tatsächlich)
4. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
4. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
2. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- PutianU-0013
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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