- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07676552
Rectointercostal Plane Block (RICPB) for Laparoscopic Cholecystectomy (RICPB)
Rectointercostal Plane Block (RICPB) for Postoperative Analgesia After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ergun Mendes, MD
- 전화번호: +905514265012
- 이메일: emendes@kuh.ku.edu.tr
연구 장소
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Istanbul
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Istanbul, Istanbul, 터키 (Türkiye), 34010
- Koç University Hospital
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연락하다:
- Ergun Mendes, MD
- 전화번호: +905514265012
- 이메일: emendes@kuh.ku.edu.tr
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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.
다른 이름들:
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활성 비교기: Port-Site Infiltration Group
Participants will receive conventional port-site local anesthetic infiltration at the end of surgery according to the study protocol.
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Conventional port-site local anesthetic infiltration will be performed at the end of surgery according to the study protocol to provide postoperative analgesia.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cumulative Postoperative Morphine Consumption
기간: Postoperative 24 hours
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Total morphine consumption administered via patient-controlled analgesia during the first 24 hours after surgery will be recorded.
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Postoperative 24 hours
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Rescue Analgesic Requirement
기간: Postoperative 24 hours
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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.
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Postoperative 24 hours
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Postoperative Complications
기간: Postoperative 24 hours
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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.
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Postoperative 24 hours
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Postoperative Pain Scores
기간: Postoperative 1, 3, 6, 12, and 24 hours
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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.
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Postoperative 1, 3, 6, 12, and 24 hours
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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