- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07850596
Quadratus Lumborum Block, Transversus Abdominis Plane Block, and Erector Spinae Block in Pediatric Abdominal Surgery
Comparing Quadratus Lumborum Block, Transversus Abdominis Plane Block, and Erector Spinae Block in Pediatric Abdominal Surgery
The aim of this study is to compare the analgesic efficacy and safety of Quadratus Lumborum (QL), Transversus Abdominis Plane (TAP), and Erector Spinae Plane (ESP) blocks in pediatric abdominal surgery.
연구 개요
상태
상세 설명
Advances in perioperative care of children continue to be made with increasing evidence-based practice for postoperative analgesia. However, moderate to severe pain is still experienced by up to 40% of hospitalized children and specific high-risk populations or types of surgery continue to present challenges.
Transversus abdominis plane (TAP) block involves the injection of local anesthesia (LA) in between the transversus abdominis (TA) and internal oblique (IO) muscles.
The Erector Spinae Plane (ESP) block is most often performed using an in-plane ultrasound-guided technique. It is a paraspinal fascial plane block in which the needle placement is between the erector spinae muscle and the thoracic transverse processes, and a local anesthetic is administered, blocking the dorsal and ventral rami of the thoracic and abdominal spinal nerves.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Menoufia
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Shibīn al Kawm, Menoufia, 이집트, 32951
- Menoufia University
-
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Children aged from 3 to12 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) Physical Status I-II.
- Scheduled for pediatric abdominal surgery.
Exclusion Criteria:
- Allergy or contraindication to bupivacaine or dexmedetomidine.
- Coagulopathy.
- Local infection at the site of the block.
- Neurological or psychiatric disorders affecting pain perception.
- Refusal of the regional technique by parents/guardians.
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 |
|---|---|
|
실험적: QL Group
Patients received quadratus lumborum (QL) block with bupivacaine 0.25% (0.5 ml/kg) + dexmedetomidine 0.5 mcg/kg. |
Patients received quadratus lumborum (QL) block with bupivacaine 0.25% (0.5 ml/kg) + dexmedetomidine 0.5 mcg/kg.
다른 이름들:
|
|
실험적: TAP group
Patients received transversus abdominis plane (TAP) block with bupivacaine 0.25% (0.5 ml/kg) + dexmedetomidine 0.5 mcg/kg |
Patients received transversus abdominis plane (TAP) block with bupivacaine 0.25% (0.5 ml/kg) + dexmedetomidine 0.5 mcg/kg.
다른 이름들:
|
|
실험적: ES Group
Patients received erector spinae plane (ESP) block with bupivacaine 0.25% (0.5 ml/kg) + dexmedetomidine 0.5 mcg/kg. |
Patients received erector spinae plane (ESP) block with bupivacaine 0.25% (0.5 ml/kg) + dexmedetomidine 0.5 mcg/kg.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Degree of pain
기간: 24 hours postoperatively
|
Degree of pain will be assessed using Wong-Baker FACES for the first 24 hours postoperative at 4, 8,12,16 and 24 hours postoperatively. Wong-Baker FACES Pain Scale, which utilizes a series of 6 faces increasing in pain severity may be used to facilitate communication and assist in pain assessment . |
24 hours postoperatively
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Total fentanyl consumption
기간: Intraoperatively
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If patient require analgesia during surgery (diagnosed by increasing heart rate and blood pressure) fentanyl 1mic/kg will be given, and total analgesic consumption will be calculated and recorded. |
Intraoperatively
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|
Heart rate
기간: Till the end of surgery (Up to 2 hours)
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Heart rate will be recorded every 15 minutes till the end of surgery. |
Till the end of surgery (Up to 2 hours)
|
|
Mean arterial blood pressure
기간: Till the end of surgery (Up to 2 hours)
|
Mean arterial blood pressure will be recorded every 15 minutes till the end of surgery. |
Till the end of surgery (Up to 2 hours)
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|
Time of each block
기간: Intraoperatively
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Time of each block will be recorded from using ultrasound probe till injection of local anaesthetic |
Intraoperatively
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Sedation score
기간: 24 hours postoperatively
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Sedation score will be recorded at 0, 15 min ,30 min postoperative 0=no sedation (wide awake). =slightly sedated (easy to arouse) 2=moderately sedated(easy to arouse but cannot stay awake) 3=heavy sedated (difficult to arouse) |
24 hours postoperatively
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Time to first rescue analgesia
기간: 24 hours postoperatively
|
Time to first rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated. |
24 hours postoperatively
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Total morphine consumption
기간: 24 hours postoperatively
|
If the pain score more than or equal to 4), opioid (morphine) 0.5 to 1 mg/kg will be given and total dose will be calculated |
24 hours postoperatively
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Incidence of postoperative complications
기간: 24 hours postoperatively
|
Incidence of postoperative complications such as hypotension, nausea and vomiting will be recorded. |
24 hours postoperatively
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 12/2024 ANET 32
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD 공유 기간
After the end of study for one year.
IPD 공유 액세스 기준
The data will be available upon a reasonable request from the corresponding author.
IPD 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
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