- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07618650
Ultrasound-Guided Transversalis Fascia Plane Block Versus Quadratus Lumborum Plane Block for Analgesia After Appendectomy in Pediatrics
Ultrasound-Guided Transversalis Fascia Plane Block Versus Quadratus Lumborum Plane Block for Analgesia After Appendectomy in Pediatrics: A Prospective Randomized Study
This study aims to compare the effectiveness of ultrasound-guided Transversalis Fascia Plane block versus Quadratus Lumborum block for postoperative pain relief in pediatrics undergoing appendectomy.
Primary outcomes:
• Proportion of patients needing rescue analgesia within the first 24 postoperative hours.
Secondary outcomes:
- Visual Analogue Scale pain intensity measurements.
- Intraoperative Heart rate and mean arterial blood pressure will be recorded.
- Time to first analgesic request for patients needing rescue analgesia (Fentanyl).
- Block-related complications (e.g., hematoma, local anesthetic toxicity, lower limb weakness).
- Parents' satisfaction score.
연구 개요
상태
상세 설명
Appendicectomy is amongst the most commonly performed surgery, with acute appendicitis being the most frequent reason for abdominal surgical emergencies in the world . The lifetime risk of appendicitis is 7-8%, with rising incidence in the newly industrialized countries . The prevailing treatment of choice for appendicitis is appendicectomy, which can be performed either 'open' or laparoscopically .
A major contributor to the pain experienced by a patient after abdominal surgery is the incision made in the abdominal wall . Almost 80% of patients undergoing surgery experience postoperative pain, and 80% of them reported moderate-to-severe pain intensity .
Traditional methods of postoperative pain management in children, such as systemic opioids and nonsteroidal anti-inflammatory drugs , may not always provide adequate relief, especially for more invasive procedures . These approaches can also be associated with side effects like sedation, nausea, and respiratory depression, which may complicate postoperative care and recovery . In recent years, regional anesthesia techniques have emerged as promising alternatives for postoperative pain management in various surgical populations Two specific regional blocks that have gained attention for their potential benefits in reducing postoperative pain after abdominal surgeries is the Quadratus Lumborum Block and the Transversus Facial Abdominal Plane block The Quadratus Lumborum Block targets the nerves supplying the lumbar plexus, providing analgesia to the anterior abdominal wall . It has been shown to be effective in adult patients undergoing lower abdominal surgery, offering improved postoperative pain scores and reduced opioid consumption compared to traditional pain management strategies .
Although, both Quadratus Lumborum Block and Transversus Facial Abdominal Plane block are frequently employed in pediatric anesthesia, evidence to guide clinical decisions on which block offers superior outcomes needs to be comprehensively reviewed. We aimed to compare the effectiveness of ultrasound-guided Transversalis Fascia Plane block versus Quadratus Lumborum block for postoperative pain relief in pediatrics undergoing appendectomy.
This study aims to compare the effectiveness of ultrasound-guided Transversalis Fascia Plane block versus Quadratus Lumborum block for postoperative pain relief in pediatrics undergoing appendectomy.
Primary outcomes:
• Proportion of patients needing rescue analgesia within the first 24 postoperative hours.
Secondary outcomes:
- Visual Analogue Scale pain intensity measurements.
- Intraoperative Heart rate and mean arterial blood pressure will be recorded.
- Time to first analgesic request for patients needing rescue analgesia (Fentanyl).
- Block-related complications (e.g., hematoma, local anesthetic toxicity, lower limb weakness).
- Parents' satisfaction score.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Tanta, 이집트
- Tanta University
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 70 patients aged between 7 and 12 years of both sexes undergoing appendectomy, American Society of Anesthesiologists (ASA) physical status of I or II
Exclusion Criteria:
- Refusal of parents to participate
- Patients with peritonitis
- History of allergy to bupivacaine and other amide local anesthetics
- Infection at the site of block needle entry
- Bleeding diathesis
- Neurological disorders
- American Society of Anesthesiologists ≥ III
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Group I: Transversalis Fascia Plane Block versus
Patients will receive general anesthesia and ultrasound-guided transversalis fascia plane block in a dose of 0.4 ml/kg of 0.25% bupivacaine administered prior to surgical excision
|
35 Patients will receive general anesthesia and ultrasound-guided transversalis fascia plane block in a dose of 0.4 ml/kg of 0.25% bupivacaine administered prior to surgical excision.
|
|
실험적: Group II :Quadratus Lumborum Plane Block
patients will receive general anesthesia and a quadratus lumborum plane block in a dose of 0.4 ml/kg of 0.25% bupivacaine administered prior to surgical excision.
|
35 patients will receive general anesthesia and a quadratus lumborum plane block in a dose of 0.4 ml/kg of 0.25% bupivacaine administered prior to surgical excision
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Proportion of patients needing rescue analgesia
기간: within the first 24 postoperative hours.
|
within the first 24 postoperative hours.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Visual Analogue Scale
기간: 24 postoperative hours
|
Visual Analogue Scale pain intensity measurements.
|
24 postoperative hours
|
공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
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
- 36264MS975/6/25
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
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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