The Efficacy of Transverse Abdominis Plane (TAP) Block in Children Undergoing Hydrocelectomy and/or Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC)
研究概览
简要总结
Study measures the difference in pain after hernia &/or hydrocele repair based on site of local anesthesia injection.
详细描述
This single-center, prospective, single blind, randomized study will enroll up to 50 subjects who are scheduled for elective hydrocelectomy and/or hernia repair. At Beaumont Health System, post-operative pain management in children is managed either via oral/parenteral opiates and opiate adjuncts, surgeon-administered field blocks (instillation of local anesthetics in the general area of incision), or via regional techniques (spinal, epidural, or peripheral nerve blocks). We have designed this study to determine if there is improved qualitative and quantitative post-operative pain control in patients receiving TAP block versus intraoperative peri-incisional, surgeon administered field block. Once informed consent has been given, each patient will be randomized (like flip of the coin) to either Transverse Abdominis Plane Block (TAP Block)or surgeon administered 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
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 2-8 years of age
- •Elective inguinal hernia repair, inguinal hernia repair with peritoneoscopy and/or hydrocelectomy to be performed in the Center for Children's Surgery, Beaumont Hospital, Royal Oak
- •American Society of Anesthesiologists physical status classification 1 and 2 (patients that have either no systemic illness, or mild systemic disease that is well controlled, eg. mild asthma)
排除标准
- •History of allergy to study medications
- •Enrollment in concurrent research study
- •Pregnant patients*
- •Students/trainees/staff*
- •Mentally disabled/cognitively impaired*
研究组 & 干预措施
TAP Group
Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.
干预措施: TAP block (Procedure)
Local Infiltration Group
Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.
干预措施: Local Infiltration (Procedure)
结局指标
主要结局
FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC)
时间窗: Admission into PACU
FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC), a five-item, three point scale that measures pain behavior on a scale of 0 - 2 which are summed to result in a total score of 0 - 10. Clinical judgment is used to interpret pain. The higher the score on the FLACC correlates with a higher pain score (0= no behaviors indicative of pain and 10= five behaviors indicative of significant pain). This scale was evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs) at admission to PACU.
次要结局
未报告次要终点
研究者
Kaveh Aslani, MD
Principal Investigator
William Beaumont Hospitals