Effects of Rectal Indomethacin Suppository on Postoperative CRBD in Patients Undergoing LRP
2026年5月25日 更新者：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.
研究概览
研究类型
介入性
注册 (估计的)
130
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Diansan SU, Cheif of Anesthesiology Department, PhD
- 电话号码：+8618616514088
- 邮箱：184872238@qq.com
研究联系人备份
- 姓名：Shuying Fu
- 电话号码：+8613616619870
- 邮箱：124045832@qq.com
学习地点
-
-
Zhejiang
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Hangzhou、Zhejiang、中国、310000
- 招聘中
- The First Affiliated Hospital, Zhejiang University School of Medicine
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接触：
- Diansan SU, Cheif of Anesthesiology Department, PhD
- 电话号码：+8618616514088
- 邮箱：184872238@qq.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：Control group
No indomethacin suppository will be administered transanally at the end of surgery.
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实验性的：Rectal administration of indomethacin suppository
Rectal administration of indomethacin suppository immediately at the end of surgery
|
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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The incidence of moderate to severe CRBD within 0-1 hour after surgery
大体时间：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;
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.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The incidence of moderate to severe CRBD at 1, 2, and 6 hours postoperatively
大体时间：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;
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
大体时间：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;
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.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年1月1日
初级完成 (估计的)
2026年12月31日
研究完成 (估计的)
2026年12月31日
研究注册日期
首次提交
2026年1月18日
首先提交符合 QC 标准的
2026年5月25日
首次发布 (实际的)
2026年5月27日
研究记录更新
最后更新发布 (实际的)
2026年5月27日
上次提交的符合 QC 标准的更新
2026年5月25日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.