Effects of Rectal Indomethacin Suppository on Postoperative Catheter-Related Bladder Discomfort in Patients Undergoing Laparoscopic Radical Prostatectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究者
Diansan Su
Chief, Department of Anesthesiology, the First Affiliated Hospital, Zhejiang University School of Medicine
Zhejiang University