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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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 analges

Первичные конечные точки

• The incidence of moderate to severe CRBD within 0-1 hour after surgery [Срок оценки: 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.]

Вторичные конечные точки (2)

• The incidence of moderate to severe CRBD at 1, 2, and 6 hours postoperatively [Срок оценки: 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 [Срок оценки: 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.]

Критерии участия

Критерии включения

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

Критерии исключения

• 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;
• Postoperative status of pelvic organs or spine that affects bladder function;
• Postoperative status of total proctocolectomy;
• Severe cardiac insufficiency (activity tolerance < 4 METs) or clearly diagnosed coronary heart disease;
• Clearly diagnosed chronic obstructive pulmonary disease (COPD) or a history of asthma;
• Hepatic insufficiency with Child-Pugh Class C;
• Chronic kidney disease requiring dialysis;
• Active peptic ulcer/hemorrhagic disease;
• Body mass index (BMI) ≤ 18 kg/m² or ≥ 28 kg/m²;
• Chronic analgesic abuse;
• Use of other nonsteroidal anti-inflammatory drugs (NSAIDs) within one week;
• Hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs);
• Mental or neurological disorders that prevent the completion of rating scales; or cognitive impairment resulting in the loss of capacity for civil conduct.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital, Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT07607990 · ZJU2025C205

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗