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

Recruiting now · Not applicable

Conditions studied: Prostate Cancer (Post Prostatectomy), Perioperative Anesthetic, Catheter-related Bladder Discomfort (CRBD)

In brief

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.

Key facts

Study ID

NCT07607990

Run by

Zhejiang University

People needed

130

Starts

2026-01-01

Expected to finish

2026-12-31

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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