Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Catheter-related Bladder Discomfort (CRBD) | — | UNRESOLVED | — |
| Perioperative Anesthetic | — | UNRESOLVED | — |
| Prostate Cancer (Post Prostatectomy) | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indomethacin suppository | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control group
- description
- No indomethacin suppository will be administered transanally at the end of surgery.
- type
- EXPERIMENTAL
- label
- Rectal administration of indomethacin suppository
- description
- Rectal administration of indomethacin suppository immediately at the end of surgery
- interventionNames
- Other: Indomethacin suppository
Primary outcomes (1)
- measure
- The incidence of moderate to severe CRBD within 0-1 hour after surgery
- timeFrame
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged 18 to 80 years old (inclusive); 2. American Society of Anesthesiologists (ASA) physical status classification Class I-III; 3. Undergoing elective laparoscopic radical prostatectomy under general anesthesia; 4. Having a clear understanding of the study, voluntarily participating, and providing informed consent signed by themselves or their family members. Exclusion Criteria: 1. 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; 2. Postoperative status of pelvic organs or spine that affects bladder function; 3. Postoperative status of total proctocolectomy; 4. Severe cardiac insufficiency (activity tolerance \< 4 METs) or clearly diagnosed coronary heart disease; 5. Clearly diagnosed chronic obstructive pulmonary disease (COPD) or a history of asthma; 6. Hepatic insufficiency with Child-Pugh Class C; 7. Chronic kidney disease requiring dialysis; 8. Active peptic ulcer/hemorrhagic disease; 9. Body mass index (BMI) ≤ 18 kg/m² or ≥ 28 kg/m²; 10. Chronic analgesic abuse; 11. Use of other nonsteroidal anti-inflammatory drugs (NSAIDs) within one week; 12. Hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs); 13. Mental or neurological disorders that prevent the completion of rating scales; or cognitive impairment resulting in the loss of capacity for civil conduct.
References
Publications (0)
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