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

NCT07607990 | Recruiting

• 1 other identifier: ZJU2025C205
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer (Post Prostatectomy); Perioperative Anesthetic; Catheter-related Bladder Discomfort (CRBD)

Keywords

catheter-related bladder discomfort; CRBD; radical prostatectomy

Outcome Measures

Primary Outcomes (1)

• 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; 1. score (mild): discomfort reported only on questioning; 2. score (moderate): discomfort reported spontaneously without behavioral response; 3. 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 Outcomes (2)

• The incidence of moderate to severe CRBD at 1, 2, and 6 hours postoperatively

  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

  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.

Study Arms (2)

Control group

NO INTERVENTION

No indomethacin suppository will be administered transanally at the end of surgery.

Rectal administration of indomethacin suppository

EXPERIMENTAL

Rectal administration of indomethacin suppository immediately at the end of surgery

Other: Indomethacin suppository

Interventions

Indomethacin suppository OTHER

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.

Rectal administration of indomethacin suppository

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Diansan SU, Cheif of Anesthesiology Department, PhD

CONTACT

+8618616514088; 184872238@qq.com

Shuying Fu

CONTACT

+8613616619870; 124045832@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Department of Anesthesiology, the First Affiliated Hospital, Zhejiang University School of Medicine

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: May 27, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 27, 2026

Record last verified: 2026-05

Locations

CN (1)