Actively Recruiting
Effects of Rectal Indomethacin Suppository on Postoperative Catheter-Related Bladder Discomfort in Patients Undergoing Laparoscopic Radical Prostatectomy: A Randomized Controlled Trial
Led by Zhejiang University · Updated on 2026-05-27
130
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the prevention of catheter-related bladder discomfort (CRBD), a common and painful condition after surgery, especially in patients undergoing laparoscopic radical prostatectomy. This trial evaluates whether a rectal indomethacin suppository given immediately after surgery can reduce the incidence and severity of CRBD, as well as other outcomes like pain and patient satisfaction. The trial is a randomized controlled study sponsored by Zhejiang University. Participants are randomly assigned to one of two groups: one group receives a 50 mg indomethacin suppository rectally at the end of surgery, while the other group receives no treatment. Standard anesthesia protocols are followed for all patients, and certain medications that might interfere with the study are avoided. The trial measures CRBD and pain at multiple time points shortly after surgery. During the study, patients will be assessed for CRBD severity, pain levels, analgesic use, other side effects, and satisfaction at 0, 1, 2, and 6 hours after surgery. The primary focus is on moderate to severe CRBD within the first hour after surgery. The entire participation period covers these early postoperative hours, with careful monitoring by the research team to record outcomes and any adverse reactions.
CONDITIONS
Brief Title
Effects of Rectal Indomethacin Suppository on Postoperative CRBD in Patients Undergoing LRP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 80 years old (inclusive)
- American Society of Anesthesiologists (ASA) physical status Class I to III
- Undergoing elective laparoscopic radical prostatectomy under general anesthesia
- Able to understand the study, voluntarily participate, and provide signed informed consent
You will not qualify if you...
- Existing bladder diseases such as overactive bladder or neurogenic bladder
- Postoperative conditions affecting bladder function, including pelvic organ or spine issues
- History of total proctocolectomy
- Severe cardiac insufficiency (activity tolerance less than 4 METs) or diagnosed coronary heart disease
- Diagnosed chronic obstructive pulmonary disease (COPD) or history of asthma
- Liver failure with Child-Pugh Class C
- Chronic kidney disease requiring dialysis
- Active peptic ulcer or bleeding disorder
- Body mass index (BMI) less than or equal to 18 kg/m² or greater than or equal to 28 kg/m²
- Chronic abuse of pain medications
- Use of other nonsteroidal anti-inflammatory drugs (NSAIDs) within the past week
- Allergy or hypersensitivity to NSAIDs
- Mental or neurological disorders preventing completion of rating scales or causing loss of legal capacity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo laparoscopic radical prostatectomy under general anesthesia. At the end of surgery, participants receive either a rectal indomethacin suppository or no suppository, depending on their group assignment, to prevent catheter-related bladder discomfort (CRBD).
1 visit (in-person)
Duration - 6 hours after surgery
Participants are monitored for catheter-related bladder discomfort (CRBD) severity and incidence immediately after extubation and at 1, 2, and 6 hours postoperatively.
4 visits (in-person) including immediately after extubation and at 1, 2, and 6 hours postoperatively
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
D
Diansan SU, Cheif of Anesthesiology Department, PhD
S
Shuying Fu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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