Transversus Abdominis Plane Block in Children Undergoing Ostomy Surgery: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Morphine Requirement
研究概览
简要总结
The primary objective of this study is to determine if the use of Transversus Abdominis Plane (TAP) blocks reduce early postoperative opioid requirements.
详细描述
Revision or closure of ostomy is a common elective surgical procedure at The Hospital for Sick Children. A retrospective audit conducted at SickKids demonstrated significant intraoperative opioid use and significant requirements for rescue opioids in recovery.
Concerns exist regarding the relative merits of opioid use in abdominal surgery. Opioids may decrease bowel motility leading to the increased incidence and duration of postoperative ileus. They may be associated with increased rates of post-operative nausea and vomiting and pruritus. Lastly children may under-report their pain or pain may not be recognized by medical staff leading to inadequate provision of analgesia. This suggests that the use of a regional technique may benefit children undergoing revision of ostomy.
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
- 年龄范围
- 3 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children undergoing revision or closure of ostomy
- •American Society of Anesthesiologists Classification 1-
- •age ≥ 3 months
排除标准
- •children undergoing an additional surgical procedure (e.g. circumcision) at an anatomical location not covered by a one-sided/ unilateral TAP block, during the same anesthetic
- •children in whom a TAP block is contraindicated, i.e. surgical scar or distorted anatomy at the site of injection
- •postoperative admission to the intensive care unit
- •children with a known allergy to bupivacaine
- •children with a history of chronic abdominal pain
- •use of opioid analgesics prior to surgery
- •pregnancy
- •impaired renal function
- •impaired hepatic function
- •known impaired cardiac function
- •hypersensitivity to sodium metabisulfite
结局指标
主要结局
Morphine Requirement
时间窗: within the first 48 hours after surgery
The primary endpoint will be the proportion of children in each group requiring two or more (≥ 2) boluses of morphine in the PACU.
次要结局
未报告次要终点
研究者
Jason Hayes
Staff Anesthesiologist
The Hospital for Sick Children