Effects of Rectal Indomethacin Suppository on Postoperative CRBD in Patients Undergoing LRP
Effects of Rectal Indomethacin Suppository on Postoperative Catheter-Related Bladder Discomfort in Patients Undergoing Laparoscopic Radical Prostatectomy: A Randomized Controlled Trial
Zhejiang University
130 participants
Jan 1, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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 Criteria13
- 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.
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Interventions
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.
Locations(1)
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NCT07607990