Ketamine Added to Quadratus Lumborum Block for Pain Relief After Infant Pyeloplasty (KETA-QLB)
Ketamine As Adjuvant to Bupivacaine in Ultrasound Guided Quadratus Lumborum Block for Infants Undergoing Open Pyeloplasty
연구 개요
상세 설명
Postoperative pain management in infants undergoing open pyeloplasty remains challenging because opioid use may be associated with adverse effects, including respiratory depression, nausea, vomiting, and delayed recovery. Regional anesthesia techniques, including ultrasound-guided quadratus lumborum (QL) block, may improve postoperative analgesia and reduce opioid requirements.
Ketamine has analgesic properties through N-methyl-D-aspartate (NMDA) receptor antagonism and has been investigated as an adjuvant to local anesthetics in regional anesthesia. However, evidence regarding its use as an adjuvant in ultrasound-guided QL block in infants undergoing pyeloplasty is limited.
This prospective randomized study aims to evaluate the effectiveness of adding ketamine to bupivacaine in ultrasound-guided QL block for infants undergoing open pyeloplasty. Forty infants aged 0-12 months scheduled for elective open pyeloplasty are randomized into two groups. One group receives ultrasound-guided QL block using bupivacaine 0.25% (0.5 mL/kg) combined with ketamine hydrochloride (1 mg/kg), while the control group receives bupivacaine 0.25% (0.5 mL/kg) alone.
The primary outcome measure is postoperative pain assessed using the CRIES pain scale during the first 24 hours after surgery. Secondary outcome measures include time to first rescue opioid administration, total postoperative opioid consumption, length of hospital stay, and occurrence of adverse events or complications.
This study seeks to determine whether ketamine may improve postoperative analgesia and reduce opioid requirements when used as an adjuvant to bupivacaine in pediatric regional anesthesia.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Alexandria, 이집트
- Alexandria University
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Infants aged 0 to 12 months
- Scheduled for elective open pyeloplasty
- Eligible for ultrasound-guided quadratus lumborum block
- Parent or legal guardian able to provide informed consent
Exclusion Criteria:
- Congenital heart disease
- Prematurity
- Mechanical ventilation dependence
- Contraindications to regional anesthesia
- Coagulopathy or bleeding disorders
- Local infection at the injection site
- Known allergy or hypersensitivity to ketamine, bupivacaine, or study medications
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Ketamine + Bupivacaine QL Block
Participants receive ultrasound-guided quadratus lumborum block using ketamine hydrochloride (1 mg/kg) combined with bupivacaine 0.25% (0.5 mL/kg) during open pyeloplasty.
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Ketamine hydrochloride (1 mg/kg) added to bupivacaine 0.25% (0.5 mL/kg) administered by ultrasound-guided quadratus lumborum block during open pyeloplasty.
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활성 비교기: Bupivacaine QL Block
Participants receive ultrasound-guided quadratus lumborum block using bupivacaine 0.25% (0.5 mL/kg) alone during open pyeloplasty.
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Bupivacaine 0.25% (0.5 mL/kg) administered by ultrasound-guided quadratus lumborum block during open pyeloplasty.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative Pain Assessed by CRIES Pain Scale by the end of 24 hours after surgery
기간: 24 hours after surgery
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Postoperative pain severity assessed using the CRIES pain scale during the first 24 hours after surgery.
Higher scores indicate greater pain severity.
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24 hours after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time to First Rescue Opioid Administration
기간: 24 hours after surgery
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Time elapsed from completion of surgery to first administration of rescue opioid analgesia (intravenous fentanyl).
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24 hours after surgery
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Total Postoperative Opioid Consumption
기간: 24 hours after surgery
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Total postoperative fentanyl consumption during the postoperative observation period.
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24 hours after surgery
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Length of Hospital Stay
기간: Until hospital discharge (approximately 1-3 days)
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Duration of hospitalization measured in days following surgery.
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Until hospital discharge (approximately 1-3 days)
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Occurrence of Postoperative Complications
기간: 24 hours after surgery until discharge
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Incidence of adverse events and complications related to the intervention or postoperative period.
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24 hours after surgery until discharge
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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
- 0307848
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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