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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer (Post Prostatectomy); Catheter-related Bladder Discomfort (CRBD); Perioperative Anesthetic
• Intervention / Treatment: Other: Indomethacin suppository

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diansan SU, Cheif of Anesthesiology Department, PhD; Phone Number: +8618616514088; Email: 184872238@qq.com
• Study Contact Backup: Name: Shuying Fu; Phone Number: +8613616619870; Email: 124045832@qq.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The First Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Diansan SU, Cheif of Anesthesiology Department, PhD; Phone Number: +8618616514088; Email: 184872238@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; No indomethacin suppository will be administered transanally at the end of surgery.
Experimental: Rectal administration of indomethacin suppository; Rectal administration of indomethacin suppository immediately at the end of surgery	Other: Indomethacin suppository; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of moderate to severe CRBD within 0-1 hour after surgery	Catheter-related bladder discomfort will be assessed immediately after extubation. The severity of catheter-related bladder discomfort was graded as follows: 0 score: no discomfort; score (mild): discomfort reported only on questioning;; score (moderate): discomfort reported spontaneously without behavioral response;; score (severe): discomfort reported spontaneously with behavioral responses (e.g., flailing limbs, vocalization, or attempting to remove the catheter). The incidence of moderate and severe CRBD within 0-1 hour postoperatively will be recorded.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of moderate to severe CRBD at 1, 2, and 6 hours postoperatively	Catheter-related bladder discomfort will be assessed. The severity of catheter-related bladder discomfort was graded as follows: 0 score: no discomfort; score (mild): discomfort reported only on questioning;; score (moderate): discomfort reported spontaneously without behavioral response;; score (severe): discomfort reported spontaneously with behavioral responses (e.g., flailing limbs, vocalization, or attempting to remove the catheter). The incidence of moderate and severe CRBD at 1, 2, and 6 hours postoperatively will be recorded.	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 at 1, 2, and 6 hours postoperatively.
CRBD severity score at 0, 1, 2, and 6 hours postoperatively	Catheter-related bladder discomfort will be assessed. The severity of catheter-related bladder discomfort was graded as follows: 0 score: no discomfort; score (mild): discomfort reported only on questioning;; score (moderate): discomfort reported spontaneously without behavioral response;; score (severe): discomfort reported spontaneously with behavioral responses (e.g., flailing limbs, vocalization, or attempting to remove the catheter). CRBD severity at 0, 1, 2, and 6 hours postoperatively will be recorded.	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 at 0,1, 2, and 6 hours postoperatively.

Collaborators and Investigators

• Sponsor: Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 18, 2026
• First Submitted That Met QC Criteria: May 25, 2026
• First Posted (Actual): May 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: catheter-related bladder discomfort; radical prostatectomy; CRBD
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: ZJU2025C205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No