Effects of Rectal Indomethacin Suppository on Postoperative CRBD in Patients Undergoing LRP
2026年5月25日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
130
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Diansan SU, Cheif of Anesthesiology Department, PhD
- 電話番号：+8618616514088
- メール：184872238@qq.com
研究連絡先のバックアップ
- 名前：Shuying Fu
- 電話番号：+8613616619870
- メール：124045832@qq.com
研究場所
-
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Zhejiang
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Hangzhou、Zhejiang、中国、310000
- 募集
- The First Affiliated Hospital, Zhejiang University School of Medicine
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コンタクト：
- Diansan SU, Cheif of Anesthesiology Department, PhD
- 電話番号：+8618616514088
- メール：184872238@qq.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：Control group
No indomethacin suppository will be administered transanally at the end of surgery.
|
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実験的：Rectal administration of indomethacin suppository
Rectal administration of indomethacin suppository immediately at the end of surgery
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The incidence of moderate to severe CRBD within 0-1 hour after surgery
時間枠：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.
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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;
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.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The incidence of moderate to severe CRBD at 1, 2, and 6 hours postoperatively
時間枠：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;
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
時間枠：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;
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.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年1月1日
一次修了 (推定)
2026年12月31日
研究の完了 (推定)
2026年12月31日
試験登録日
最初に提出
2026年1月18日
QC基準を満たした最初の提出物
2026年5月25日
最初の投稿 (実際)
2026年5月27日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月27日
QC基準を満たした最後の更新が送信されました
2026年5月25日
最終確認日
2026年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。