Multimodal Fascial Plane Block for Postoperative Analgesia in Isolated CABG Surgery (BLOCKCABG)
Effect of Induction-Time Multimodal Fascial Plane Block on Postoperative Analgesia and Opioid Consumption in Patients Undergoing Isolated Coronary Artery Bypass Grafting: A Prospective Randomized Controlled Trial
Postoperative pain following coronary artery bypass grafting (CABG) via median sternotomy remains a significant clinical problem and is associated with increased opioid consumption and postoperative complications. Fascial plane blocks have emerged as part of multimodal analgesia strategies in cardiac surgery.
This prospective, randomized, controlled, single-blinded study aims to evaluate the effect of an induction-time multimodal fascial plane block package-consisting of bilateral superficial parasternal block, bilateral serratus anterior plane block, and adductor canal block-on postoperative analgesia, opioid consumption, and clinical outcomes in patients undergoing elective isolated CABG with saphenous vein graft harvesting.
Patients will be randomized in a 1:1 ratio to receive either the multimodal fascial plane block package in addition to standard postoperative analgesia or standard postoperative analgesia alone. The primary outcome is total opioid consumption within the first 24 postoperative hours. Secondary outcomes include pain scores, time to first opioid requirement, extubation time, postoperative pulmonary complications, atrial fibrillation, and length of ICU and hospital stay.
연구 개요
상태
상세 설명
Median sternotomy, chest drains, and saphenous vein graft harvesting are major contributors to postoperative pain following CABG surgery. Inadequate pain control may impair respiratory mechanics, delay mobilization, and increase postoperative morbidity. Multimodal analgesic approaches aim to reduce opioid requirements and improve recovery profiles.
This single-center, prospective, randomized controlled trial will include adult patients (18-80 years) scheduled for elective isolated CABG with saphenous vein graft harvesting. After written informed consent, eligible participants will be randomly assigned to either the intervention group or the control group.
The intervention group will receive ultrasound-guided bilateral superficial parasternal block, bilateral serratus anterior plane block, and adductor canal block following induction of general anesthesia and prior to surgical incision. The control group will receive standard perioperative analgesia without regional block. All other perioperative management will be standardized.
The primary endpoint is total opioid consumption within the first 24 hours postoperatively. Secondary endpoints include pain scores at predefined time points (6, 12, 24, and 48 hours), time to first opioid requirement, extubation time, incidence of postoperative pulmonary complications and atrial fibrillation, ICU length of stay, hospital length of stay, and time to first mobilization.
The study is designed to assess whether a multimodal fascial plane block strategy can improve postoperative analgesia and reduce opioid use in cardiac surgery patients.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Selen Topalel, MD
- 전화번호: +90 533 506 33 20
- 이메일: selentopalel26@gmail.com
연구 장소
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Diyarbakır
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Diyarbakır, Diyarbakır, 터키 (Türkiye)
- 모병
- University of Health Sciences, Diyarbakir Gazi Yasargil Training and Research Hospital
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연락하다:
- Selen Topalel, MD
- 전화번호: +90 533 506 33 20
- 이메일: selentopalel26@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age between 18 and 80 years
- Scheduled for elective isolated coronary artery bypass grafting (CABG) with saphenous vein graft harvesting
- ASA physical status II-IV
- Ability to provide written informed consent
Exclusion Criteria:
- Known coagulopathy or contraindication to regional anesthesia
- Use of anticoagulant therapy precluding regional block
- Known allergy to local anesthetics
- Local infection at planned block sites
- Chronic opioid use or chronic pain syndrome
- Emergency surgery
- Redo sternotomy
- Severe neurological disorder affecting pain assessment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Multimodal Fascial Plane Block Group
Participants will receive a multimodal fascial plane block package consisting of bilateral superficial parasternal block, bilateral serratus anterior plane block, and adductor canal block following induction of general anesthesia and before surgical incision, in addition to standard perioperative analgesia.
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Participants will receive ultrasound-guided bilateral superficial parasternal block, bilateral serratus anterior plane block, and adductor canal block after induction of general anesthesia and before surgical incision.
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활성 비교기: Standard Analgesia Group
Participants will receive standard perioperative and postoperative analgesia without regional fascial plane block intervention.
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Participants will receive standard institutional perioperative and postoperative analgesia without regional fascial plane block.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total opioid consumption within the first 48 postoperative hours
기간: Through 48 hours after surgery
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Total cumulative tramadol consumption (mg) during the first 48 hours following surgery.
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Through 48 hours after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative pain intensity scores
기간: At 6, 12, 24, and 48 hours after surgery
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Pain intensity measured using the Numeric Rating Scale (NRS; 0-10) at rest and during movement at predefined postoperative time points.
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At 6, 12, 24, and 48 hours after surgery
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Time to first rescue analgesic requirement
기간: Within 48 hours after surgery
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Time from arrival to the intensive care unit to first rescue analgesic administration (hours).
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Within 48 hours after surgery
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Extubation time
기간: From ICU admission to extubation, assessed through 24 hours after surgery
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Time from arrival to the intensive care unit to successful tracheal extubation (hours).
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From ICU admission to extubation, assessed through 24 hours after surgery
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공동 작업자 및 조사자
수사관
- 수석 연구원: Selen Topalel, MD, University of Health Sciences, Diyarbakir Gazi Yasargil Training and Research Hospital
간행물 및 유용한 링크
일반 간행물
- Zengin EN, Yigit H, Cobas M, Salman N, Asli Demir Z. The analgesic effects of combined bilateral parasternal block and serratus anterior plane block for coronary artery bypass grafting surgery. BMC Anesthesiol. 2024 Aug 5;24(1):274. doi: 10.1186/s12871-024-02659-7.
- Kalli A, Vistbacka J, Moilanen E, Jarvela K, Mennander A. Superficial Parasternal Intercostal Plane Block and Full Sternotomy; A Randomized Trial. Eur J Cardiothorac Surg. 2025 Jul 1;67(7):ezaf226. doi: 10.1093/ejcts/ezaf226.
- Zhang J, Luo F, Zhang X, Xue Y. Ultrasound-Guided Continuous Parasternal Intercostal Block Relieves Postoperative Pain After Open Cardiac Surgery: A Case Series. J Cardiothorac Vasc Anesth. 2022 Jul;36(7):2051-2054. doi: 10.1053/j.jvca.2021.05.028. Epub 2021 May 21.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 연구와 관련된 용어
기타 연구 ID 번호
- GY-CABG-2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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