- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07615231
EOIB vs. TAPB in Minimally Invasive Hepatectomy (EOIvsTAPinLIV)
External Oblique Intercostal Plane Block and Subcostal Transversus Abdominis Plane Block in Minimally Invasive Hepatectomy: Non-inferiority Trial
연구 개요
상세 설명
Anesthesia and Induction Except for the specific nerve block technique assigned to each group, all participants will receive the standard anesthetic care for minimally invasive hepatectomy at Seoul National University Hospital. No premedication will be administered before entering the operating room, where standard non-invasive monitoring, will be established. Anesthesia will be induced with remifentanil target-controlled infusion, propofol, and rocuronium after loss of consciousness. Endotracheal intubation will be performed after neuromuscular blockade. Anesthesia will be maintained with desflurane and remifentanil infusion, adjusted according to clinical requirements. As a part of the perioperative care, palonosetron (0.075 mg) and dexamethasone (5 mg) will be given intravenously during induction for antiemetic prophylaxis, and intravenous acetaminophen (1 g) and nefopam (20 mg) will be administered before the start of surgery.
Interventional Procedures Following the induction of anesthesia, all nerve blocks will be performed under ultrasound guidance using a high-frequency convex probe covered with a sterile sheath under aseptic conditions. For the External Oblique Intercostal Block (EOIB) group, the T10 rib will be located at the intersection of the midclavicular line and the umbilical line, and the clinician will count upwards to identify the T6, T7, and T8 ribs. The probe will then be placed perpendicular to the rib trajectory at the T6-7 or T7-8 intercostal space to identify the external intercostal plane. Using an in-plane approach with a 10-cm echoplex needle, the plane will be confirmed via hydrodissection with 1-2 mL of saline, followed by the bilateral injection of 20 mL of 0.375% ropivacaine per side (total 40 mL). In contrast, for the Subcostal Transversus Abdominis Plane (TAP) block group, the probe will be placed on the subxiphoid midline and moved laterally along the T12 rib to identify the transversus abdominis plane. The needle will be advanced to the plane between the internal oblique and transversus abdominis muscles, and similarly, 20 mL of 0.375% ropivacaine will be injected into each side (total 40 mL) after confirming the plane with saline.
Postoperative Analgesia and Outcomes Postoperative pain will be managed primarily using a fentanyl-based patient-controlled analgesia (PCA) device (Accumate 1200, Woo Young Medical), set with a loading dose of 50 mcg, a demand-only bolus of 20 mcg, and a 10-minute lockout time without basal infusion. A scheduled non-opioid regimen, consisting of intravenous acetaminophen (1 g) and nefopam (20 mg) every 8 hours, will be maintained for 48 hours, transitioning to oral acetaminophen (650 mg) once oral intake resumes. In the Post-Anesthesia Care Unit (PACU), if a patient reports a Numerical Rating Scale (NRS) score of 7 or higher despite active PCA use (exceeding four times per hour), a rescue dose of 50 mcg of intravenous fentanyl will be provided. The primary outcome of this study is the cumulative opioid consumption at 24 hours postoperatively. Secondary outcomes include cumulative opioid consumption at 1, 6, 12, and 48 hours, NRS scores at predefined intervals (PACU, 24, and 48 hours), total intraoperative remifentanil dose, the incidence of postoperative nausea and vomiting, and the time to first ambulation.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: HKYoon
- 전화번호: 82220722467
- 이메일: warren83@snu.ac.kr
연구 장소
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Seoul, 대한민국, 03080
- SNUH
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연락하다:
- HKYoon
- 전화번호: 82220722467
- 이메일: warren83@snu.ac.kr
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Scheduled to undergo elective robotic or laparoscopic minimally invasive hepatectomy
Exclusion Criteria:
- American Society of Anesthesiologists physical status IV or higher
- History of chronic pain or current use of analgesics, antidepressants, or anticonvulsants for pain management
- Known hypersensitivity to general anesthetics, opioids, or local anesthetics
- Conversion to open hepatectomy
- Requirement for mechanical ventilation for more than 2 hours within 48 hours postoperatively
- Any other clinical condition that makes the patient unsuitable for participation in the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: External Oblique Intercostal Block (EOIB) group
patients who receive EOI block
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Following the induction of general anesthesia, patients in this group will receive an ultrasound-guided bilateral external intercostal fascial plane block.
A total of 40 mL of 0.375% ropivacaine (20 mL per side) will be injected into the plane between the external intercostal muscle and the internal intercostal muscle at the T6-7 or T7-8 level.
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활성 비교기: Transverse Abdominis Plane (TAP) block group
Patients who receive TAP block
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Following the induction of general anesthesia, patients in this group will receive an ultrasound-guided bilateral subcostal transversus abdominis plane block.
A total of 40 mL of 0.375% ropivacaine (20 mL per side) will be injected into the fascial plane between the internal oblique and transversus abdominis muscles along the subcostal margin.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cumulative opioid consumption at 24 hours postoperatively
기간: From the end of surgery up to 24 hours postoperatively
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The total amount of intravenous fentanyl administered via patient-controlled analgesia (PCA) and as rescue boluses will be recorded and converted to intravenous morphine equivalents for standardized comparison.
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From the end of surgery up to 24 hours postoperatively
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cumulative Opioid Consumption at 1, 6, 12, and 48 hours postoperatively
기간: 1, 6, 12, and 48 hours after surgery completion.
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Total amount of fentanyl administered via IV-PCA and rescue boluses.
All doses will be recorded and analyzed at each specified time point.
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1, 6, 12, and 48 hours after surgery completion.
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Postoperative pain intensity measured by Numerical Rating Scale (NRS)
기간: During Post-Anesthesia Care Unit (PACU) stay, and at 24 and 48 hours postoperatively.
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Pain intensity is assessed using a scale from 0 to 10, where 0 indicates "no pain" and 10 indicates "the worst pain imaginable."
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During Post-Anesthesia Care Unit (PACU) stay, and at 24 and 48 hours postoperatively.
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Total dose of intraoperative remifentanil
기간: During the intraoperative period (from induction to skin closure).
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During the intraoperative period (from induction to skin closure).
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Incidence of Postoperative Nausea and Vomiting
기간: Up to 48 hours postoperatively.
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Up to 48 hours postoperatively.
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Time to first ambulation
기간: From the end of surgery up to 48 hours postoperatively (or until the first occurrence).
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From the end of surgery up to 48 hours postoperatively (or until the first occurrence).
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공동 작업자 및 조사자
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 연구와 관련된 용어
기타 연구 ID 번호
- 2512-081-1703
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
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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