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

25 maj 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

130

Fas

  • Inte tillämpbar

Kontakter och platser

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

Studiekontakt

  • Namn: Diansan SU, Cheif of Anesthesiology Department, PhD
  • Telefonnummer: +8618616514088
  • E-post: 184872238@qq.com

Studera Kontakt Backup

Studieorter

  • Kina
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310000
        • Rekrytering
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Kontakt:
          • Diansan SU, Cheif of Anesthesiology Department, PhD
          • Telefonnummer: +8618616514088
          • E-post: 184872238@qq.com

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 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.

Studieplan

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

Hur är studien utformad?

Designdetaljer

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

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Control group
No indomethacin suppository will be administered transanally at the end of surgery.
Experimentell: Rectal administration of indomethacin suppository
Rectal administration of indomethacin suppository immediately at the end of surgery
Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The incidence of moderate to severe CRBD within 0-1 hour after surgery
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The incidence of moderate to severe CRBD at 1, 2, and 6 hours postoperatively
Tidsram: 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
Tidsram: 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.

Samarbetspartners och utredare

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Sponsor

Zhejiang University

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 (Faktisk)

1 januari 2026

Primärt slutförande (Beräknad)

31 december 2026

Avslutad studie (Beräknad)

31 december 2026

Studieregistreringsdatum

Först inskickad

18 januari 2026

Först inskickad som uppfyllde QC-kriterierna

25 maj 2026

Första postat (Faktisk)

27 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ZJU2025C205

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