A Prospective, Double-blinded, Randomized Comparison of Caudal Analgesia Versus Ultrasound Guided Rectus Sheath Blocks for Umbilical Herniorrhaphy in the Pediatric Population
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Post-operative Pain Score
研究概览
简要总结
The literature has clearly demonstrated that the effective treatment of postoperative pain in infants and children is challenging. In an effort to improve postoperative analgesia while limiting opioid-related adverse effects, there continues to be an increased use of regional anesthetic techniques in infants and children. Although the pediatric caudal remains the most commonly used pediatric regional anesthetic technique, it has been demonstrated that effective analgesia can be provided with the use of peripheral nerve blockade even in the pediatric-aged patient. The purpose of this study is to prospectively compare post-operative pain relief in pediatric patients undergoing umbilical hernia repair who have received either a caudal block or bilateral rectus sheath blocks for analgesia
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I or II
- •Weight less than or equal to 20 kg
- •Presenting for repair of umbilical hernia
排除标准
- •ASA physical status > II
- •Weight greater than 20 kg
- •Co-morbid diseases (cardiac, pulmonary, neurological disease)
- •Patients having concomitant procedures (circumcision, orchiopexy, etc.)
研究组 & 干预措施
Caudal epidural
The caudal epidural block will be delivered with 1.5ml/kg of 0.25% Bupivacaine up to a maximum of 30 mL.
干预措施: Bupivacaine (Drug)
Rectus sheath
The rectus sheath block will be performed with 0.1ml/kg of 0.25% Bupivacaine on each side at the T9-T10 distribution under ultrasound guidance.
干预措施: Bupivacaine (Drug)
Local
The surgeon will inject either 0.5% Bupivicaine 0.5ml/kg or 0.25% Bupivicaine 1ml/kg at the surgeon's discretion.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Post-operative Pain Score
时间窗: 30 minutes
Hannallah et al developed the Objective Pain Scale (OPS) to monitor pain in children after surgery. Parameters: (1) systolic blood pressure, (2) crying, (3) movement, (4) agitation (confused, excited), (5) complains of pain (may not be possible in younger children). Interpretation: minimum score: 0; maximum score: 10; maximum score if too young to complain of pain: 8; the higher the score, the greater the degree of pain.
次要结局
未报告次要终点
研究者
Tarun Bhalla, MD
Attending Anesthesiologist
Nationwide Children's Hospital