Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Effects of Rectal Indomethacin Suppository on Postoperative CRBD in Patients Undergoing LRP

25 mei 2026 bijgewerkt door: Diansan Su, Zhejiang University

Effects of Rectal Indomethacin Suppository on Postoperative Catheter-Related Bladder Discomfort in Patients Undergoing Laparoscopic Radical Prostatectomy: A Randomized Controlled Trial

The postoperative incidence of catheter-related bladder discomfort (CRBD) ranges from 47% to 95%. It increases postoperative pain and agitation, thus requiring early intervention. Although a variety of drugs are used for the prevention or treatment of CRBD, the adverse reactions of most of these drugs have limited their clinical application. In long-term clinical practice, we found that indomethacin suppository has a good therapeutic effect on the discomfort of pelvic-related organs caused by nociceptive stimulation. However, its preventive effect on CRBD has not been reported yet. We hypothesized that indomethacin suppository has a preventive effect on postoperative CRBD. To verify this hypothesis, patients undergoing laparoscopic radical prostatectomy were enrolled in the study. Patients in the intervention group received 50 mg of indomethacin suppository via the rectal route immediately after surgery, while those in the control group received no treatment. The severity of CRBD, pain scores, consumption of analgesics, other perioperative adverse reactions, and patient satisfaction were observed and recorded at 0, 1, 2, and 6 hours after surgery.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

130

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Diansan SU, Cheif of Anesthesiology Department, PhD
  • Telefoonnummer: +8618616514088
  • E-mail: 184872238@qq.com

Studie Contact Back-up

Studie Locaties

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Werving
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
          • Diansan SU, Cheif of Anesthesiology Department, PhD
          • Telefoonnummer: +8618616514088
          • E-mail: 184872238@qq.com

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  1. Aged 18 to 80 years old (inclusive);
  2. American Society of Anesthesiologists (ASA) physical status classification Class I-III;
  3. Undergoing elective laparoscopic radical prostatectomy under general anesthesia;
  4. Having a clear understanding of the study, voluntarily participating, and providing informed consent signed by themselves or their family members.

Exclusion Criteria:

  1. Pre-existing bladder diseases, such as overactive bladder (frequency of micturition > 3 times per night or > 8 times within 24 hours), neurogenic bladder, and bladder outlet obstruction;
  2. Postoperative status of pelvic organs or spine that affects bladder function;
  3. Postoperative status of total proctocolectomy;
  4. Severe cardiac insufficiency (activity tolerance < 4 METs) or clearly diagnosed coronary heart disease;
  5. Clearly diagnosed chronic obstructive pulmonary disease (COPD) or a history of asthma;
  6. Hepatic insufficiency with Child-Pugh Class C;
  7. Chronic kidney disease requiring dialysis;
  8. Active peptic ulcer/hemorrhagic disease;
  9. Body mass index (BMI) ≤ 18 kg/m² or ≥ 28 kg/m²;
  10. Chronic analgesic abuse;
  11. Use of other nonsteroidal anti-inflammatory drugs (NSAIDs) within one week;
  12. Hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs);
  13. Mental or neurological disorders that prevent the completion of rating scales; or cognitive impairment resulting in the loss of capacity for civil conduct.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Control group
No indomethacin suppository will be administered transanally at the end of surgery.
Experimenteel: Rectal administration of indomethacin suppository
Rectal administration of indomethacin suppository immediately at the end of surgery
Ander: Indomethacin suppository
All patients received preoperative education on distinguishing catheter-related bladder discomfort (CRBD) from surgical somatic pain. Anesthesia was induced with sufentanil 3μg/kg, propofol 2mg/kg and rocuronium 0.6mg/kg. Anesthesia was maintained with combined propofol, remifentanil and sevoflurane. Fifteen minutes before surgery completion, intravenous ondansetron 4 mg was given for postoperative nausea and vomiting prophylaxis, and sufentanil 1 μg/kg was administered for postoperative analgesia. Drugs potentially interfering with study outcomes including dexmedetomidine, dezocine, tramadol and other non-steroidal anti-inflammatory drugs were prohibited. At the end of surgery when removing sterile drapes, interventions were performed as follows: Rectal administration of 50 mg indomethacin suppository.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The incidence of moderate to severe CRBD within 0-1 hour after surgery
Tijdsspanne: The postoperative time was calculated from the moment the patient was extubated, and the patient's catheter-related bladder discomfort (CRBD) was assessed immediately after extubation. Patients will be followed during the first hour postoperatively.

Catheter-related bladder discomfort will be assessed immediately after extubation.

The severity of catheter-related bladder discomfort was graded as follows:

0 score: no discomfort;

  1. score (mild): discomfort reported only on questioning;
  2. score (moderate): discomfort reported spontaneously without behavioral response;
  3. score (severe): discomfort reported spontaneously with behavioral responses (e.g., flailing limbs, vocalization, or attempting to remove the catheter).

The incidence of moderate and severe CRBD within 0-1 hour postoperatively will be recorded.
The postoperative time was calculated from the moment the patient was extubated, and the patient's catheter-related bladder discomfort (CRBD) was assessed immediately after extubation. Patients will be followed during the first hour postoperatively.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The incidence of moderate to severe CRBD at 1, 2, and 6 hours postoperatively
Tijdsspanne: The postoperative time was calculated from the moment the patient was extubated, and the patient's catheter-related bladder discomfort (CRBD) was assessed immediately after extubation. Patients will be followed at 1, 2, and 6 hours postoperatively.

Catheter-related bladder discomfort will be assessed.

The severity of catheter-related bladder discomfort was graded as follows:

0 score: no discomfort;

  1. score (mild): discomfort reported only on questioning;
  2. score (moderate): discomfort reported spontaneously without behavioral response;
  3. score (severe): discomfort reported spontaneously with behavioral responses (e.g., flailing limbs, vocalization, or attempting to remove the catheter).

The incidence of moderate and severe CRBD at 1, 2, and 6 hours postoperatively will be recorded.
The postoperative time was calculated from the moment the patient was extubated, and the patient's catheter-related bladder discomfort (CRBD) was assessed immediately after extubation. Patients will be followed at 1, 2, and 6 hours postoperatively.
CRBD severity score at 0, 1, 2, and 6 hours postoperatively
Tijdsspanne: The postoperative time was calculated from the moment the patient was extubated, and the patient's catheter-related bladder discomfort (CRBD) was assessed immediately after extubation. Patients will be followed at 0,1, 2, and 6 hours postoperatively.

Catheter-related bladder discomfort will be assessed.

The severity of catheter-related bladder discomfort was graded as follows:

0 score: no discomfort;

  1. score (mild): discomfort reported only on questioning;
  2. score (moderate): discomfort reported spontaneously without behavioral response;
  3. score (severe): discomfort reported spontaneously with behavioral responses (e.g., flailing limbs, vocalization, or attempting to remove the catheter).

CRBD severity at 0, 1, 2, and 6 hours postoperatively will be recorded.
The postoperative time was calculated from the moment the patient was extubated, and the patient's catheter-related bladder discomfort (CRBD) was assessed immediately after extubation. Patients will be followed at 0,1, 2, and 6 hours postoperatively.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Zhejiang University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 januari 2026

Primaire voltooiing (Geschat)

31 december 2026

Studie voltooiing (Geschat)

31 december 2026

Studieregistratiedata

Eerst ingediend

18 januari 2026

Eerst ingediend dat voldeed aan de QC-criteria

25 mei 2026

Eerst geplaatst (Werkelijk)

27 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

25 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ZJU2025C205

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren