Rectointercostal Plane Block (RICPB) for Laparoscopic Cholecystectomy (RICPB)
Rectointercostal Plane Block (RICPB) for Postoperative Analgesia After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
調査の概要
状態
詳細な説明
Laparoscopic cholecystectomy is one of the most commonly performed abdominal surgical procedures. Although it is considered a minimally invasive technique, patients frequently experience moderate postoperative pain resulting from trocar insertion sites, surgical manipulation, and irritation of the abdominal wall and peritoneum. Effective postoperative pain management is essential to facilitate early mobilization, improve patient comfort, reduce opioid consumption, and enhance recovery.
The rectointercostal plane block (RICPB) is an ultrasound-guided fascial plane block that has recently emerged as a potential analgesic technique for upper abdominal surgery. By depositing local anesthetic between the rectus abdominis muscle and the costal cartilages/intercostal muscles, RICPB may provide analgesia to the anterior upper abdominal wall. However, evidence regarding its effectiveness in laparoscopic cholecystectomy remains limited.
This single-center, prospective, randomized controlled trial is designed to evaluate the analgesic efficacy of ultrasound-guided rectointercostal plane block in patients undergoing elective laparoscopic cholecystectomy. Eligible patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-III will be enrolled after providing written informed consent. Participants will be randomly allocated in a 1:1 ratio to either the RICPB group or the control group.
Patients assigned to the RICPB group will receive an ultrasound-guided unilateral right-sided rectointercostal plane block with 30 mL of 0.25% bupivacaine at the end of surgery before emergence from anesthesia. Patients in the control group will receive conventional port-site local anesthetic infiltration according to institutional practice. All patients will undergo a standardized general anesthesia protocol and receive the same multimodal postoperative analgesic regimen.
Postoperative pain assessments will be performed using the Numeric Rating Scale (NRS). Opioid consumption, pain scores and postoperative complications, including postoperative nausea and vomiting (PONV), will be recorded during the first 24 postoperative hours.
The primary outcome of the study is cumulative opioid consumption during the first 24 postoperative hours. Secondary outcomes include postoperative NRS pain scores, rescue analgesic requirements, and the incidence of postoperative complications. The study aims to determine whether ultrasound-guided rectointercostal plane block provides superior postoperative analgesia compared with conventional port-site local anesthetic infiltration in patients undergoing laparoscopic cholecystectomy.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Ergun Mendes, MD
- 電話番号:+905514265012
- メール:emendes@kuh.ku.edu.tr
研究場所
-
-
Istanbul
-
Istanbul、Istanbul、トルコ(Türkiye)、34010
- Koc University Hospital
-
コンタクト:
- Ergun Mendes, MD
- 電話番号:+905514265012
- メール:emendes@kuh.ku.edu.tr
-
-
参加基準
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
説明
Inclusion Criteria:
- Age between 18 and 65 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective laparoscopic cholecystectomy
- Body mass index (BMI) between 18 and 35 kg/m²
- Ability to understand the study procedures and provide written informed consent
Exclusion Criteria:
- Refusal to participate or inability to provide informed consent
- Known allergy or hypersensitivity to local anesthetics, opioids, or study medications
- Chronic opioid use or chronic pain syndrome
- Coagulation disorders or ongoing anticoagulant therapy
- Infection at the planned injection site
- Pregnancy or breastfeeding
- Cognitive impairment or inability to communicate pain scores
- Severe hepatic, renal, cardiac, or respiratory disease judged by the investigator to interfere with study participation
- Conversion from laparoscopic to open surgery
- Previous upper abdominal surgery that may interfere with the block technique or pain assessment
研究計画
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:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:RICPB Group
Participants will receive an ultrasound-guided unilateral right-sided rectointercostal plane block (RICPB) with 30 mL of 0.25% bupivacaine at the end of surgery before emergence from anesthesia.
|
Ultrasound-guided unilateral right-sided rectointercostal plane block (RICPB) will be performed at the end of surgery before emergence from anesthesia.
A total of 30 mL of 0.25% bupivacaine will be injected into the rectointercostal plane under ultrasound guidance.
他の名前:
|
|
アクティブコンパレータ:Port-Site Infiltration Group
Participants will receive conventional port-site local anesthetic infiltration at the end of surgery according to the study protocol.
|
Conventional port-site local anesthetic infiltration will be performed at the end of surgery according to the study protocol to provide postoperative analgesia.
|
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 |
|---|---|---|
|
Cumulative Postoperative Morphine Consumption
時間枠:Postoperative 24 hours
|
Total morphine consumption administered via patient-controlled analgesia during the first 24 hours after surgery will be recorded.
|
Postoperative 24 hours
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Rescue Analgesic Requirement
時間枠:Postoperative 24 hours
|
The requirement for rescue analgesia during the first 24 postoperative hours will be recorded.
Rescue analgesia will be administered according to the study protocol when the NRS pain score is 4 or higher.
|
Postoperative 24 hours
|
|
Postoperative Complications
時間枠:Postoperative 24 hours
|
The incidence of postoperative complications, including postoperative nausea and vomiting (PONV), pruritus, respiratory complications, and other adverse events occurring during the postoperative period, will be recorded.
|
Postoperative 24 hours
|
|
Postoperative Pain Scores
時間枠:Postoperative 1, 3, 6, 12, and 24 hours
|
Pain intensity will be assessed using the Numeric Rating Scale (NRS; 0-10) at predefined postoperative time points.
NRS, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.
Higher scores indicate worse pain.
|
Postoperative 1, 3, 6, 12, and 24 hours
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Alver S, Sakul BU, Ansen G, Pence KB, Alici HA. Recto-intercostal fascial plane block: Another novel fascial plane block. J Clin Anesth. 2023 Oct;89:111163. doi: 10.1016/j.jclinane.2023.111163. Epub 2023 Jun 7. No abstract available.
- Mendes E, Gokkaya Z, Halis A, Uymaz DS, Gurkan Y. Rectointercostal plane block for postoperative analgesia in preperitoneal enhanced-view totally extraperitoneal umbilical hernia repair: a new indication area. Minerva Anestesiol. 2026 Jan 27. doi: 10.23736/S0375-9393.25.19781-2. Online ahead of print. No abstract available.
- Mendes E, Yaylak D, Sincer Y, Uymaz DS, Gurkan Y. Rectointercostal Fascial Plane Block as a Practical Option for Somatic Analgesia in Gastric Bypass Surgery: A Case Report. A A Pract. 2025 Nov 10;19(11):e02100. doi: 10.1213/XAA.0000000000002100. eCollection 2025 Nov 1.
- Ciftci B, Ahiskalioglu A, Tulgar S. The recto-intercostal fascial plane block: An anatomically grounded solution for upper abdominal analgesia. Indian J Anaesth. 2026 Apr;70(4):601-603. doi: 10.4103/ija.ija_1248_25. Epub 2026 Apr 20. No abstract available.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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。