Ketamine As Adjuvant to Bupivacaine in Ultrasound Guided Quadratus Lumborum Block for Infants Undergoing Open Pyeloplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
This prospective randomized study evaluates the effect of adding ketamine to bupivacaine in ultrasound-guided quadratus lumborum (QL) block for postoperative pain management in infants undergoing open pyeloplasty. Forty infants aged 0-12 months undergoing elective open pyeloplasty are randomly assigned to receive either QL block with bupivacaine plus ketamine or QL block with bupivacaine alone. Postoperative pain is assessed using the CRIES pain scale. Additional outcomes include duration of analgesia, rescue opioid requirements, total opioid consumption, length of hospital stay, and occurrence of complications.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Medication solutions were prepared by an independent anesthetist not involved in patient care or data collection. The anesthetist performing the block, surgical and nursing staff, and outcome assessors were blinded to group allocation and study medications.
入排标准
- 年龄范围
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究者
ahmed ragab
lecturer
Alexandria University