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

2026년 5월 25일 업데이트: Diansan Su, Zhejiang University

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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

130

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Diansan SU, Cheif of Anesthesiology Department, PhD
  • 전화번호: +8618616514088
  • 이메일: 184872238@qq.com

연구 연락처 백업

연구 장소

  • 중국
    • Zhejiang
      • Hangzhou, Zhejiang, 중국, 310000
        • 모병
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • 연락하다:
          • Diansan SU, Cheif of Anesthesiology Department, PhD
          • 전화번호: +8618616514088
          • 이메일: 184872238@qq.com

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: Control group
No indomethacin suppository will be administered transanally at the end of surgery.
실험적: Rectal administration of indomethacin suppository
Rectal administration of indomethacin suppository immediately at the end of surgery
다른: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
The incidence of moderate to severe CRBD within 0-1 hour after surgery
기간: 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.

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.

2차 결과 측정

결과 측정
측정값 설명
기간
The incidence of moderate to severe CRBD at 1, 2, and 6 hours postoperatively
기간: 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.

Catheter-related bladder discomfort will be assessed.

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 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
기간: 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.

Catheter-related bladder discomfort will be assessed.

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).

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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Zhejiang University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 1월 1일

기본 완료 (추정된)

2026년 12월 31일

연구 완료 (추정된)

2026년 12월 31일

연구 등록 날짜

최초 제출

2026년 1월 18일

QC 기준을 충족하는 최초 제출

2026년 5월 25일

처음 게시됨 (실제)

2026년 5월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 25일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • ZJU2025C205

개별 참가자 데이터(IPD) 계획

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미정

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아니

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