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

25 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

130

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Diansan SU, Cheif of Anesthesiology Department, PhD
  • Numéro de téléphone: +8618616514088
  • E-mail: 184872238@qq.com

Sauvegarde des contacts de l'étude

  • Nom: Shuying Fu
  • Numéro de téléphone: +8613616619870
  • E-mail: 124045832@qq.com

Lieux d'étude

  • Chine
    • Zhejiang
      • Hangzhou, Zhejiang, Chine, 310000
        • Recrutement
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
          • Diansan SU, Cheif of Anesthesiology Department, PhD
          • Numéro de téléphone: +8618616514088
          • E-mail: 184872238@qq.com

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Control group
No indomethacin suppository will be administered transanally at the end of surgery.
Expérimental: Rectal administration of indomethacin suppository
Rectal administration of indomethacin suppository immediately at the end of surgery
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
The incidence of moderate to severe CRBD within 0-1 hour after surgery
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
The incidence of moderate to severe CRBD at 1, 2, and 6 hours postoperatively
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Zhejiang University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 janvier 2026

Achèvement primaire (Estimé)

31 décembre 2026

Achèvement de l'étude (Estimé)

31 décembre 2026

Dates d'inscription aux études

Première soumission

18 janvier 2026

Première soumission répondant aux critères de contrôle qualité

25 mai 2026

Première publication (Réel)

27 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

27 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • ZJU2025C205

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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