Randomized Prospective Comparison of Analgesic Efficacy of Surgeon Performed IIlioinguinal/Iliohypogastric Blockade With Ultrasound-Guided TAP Blockade in Pediatric Patients Undergoing Unilateral Herniorrhaphy on an Outpatient Basis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Efficacy Outcome
研究概览
简要总结
The purpose of this research study is to find the best way to decrease pain in children right after surgery whom have had their hernia fixed. Right now, there are two different ways surgeons and anesthesia providers try to decrease pain. It is not clear if one way is better than the other. The method used is often chosen by which one the doctor has more experience using. The Investigator plans to find out if one of the methods is more effective and/or safer than the other method.
The results of this study will help learn how to best control pain in children having surgery for hernia repair.
详细描述
Unilateral inguinal herniorrhaphy is a commonly performed surgical procedure in the pediatric population. Multimodal anesthesia consisting of systemic narcotics, surgical wound infiltration with local anesthetic and ilioinguinal and/or iliohypogastric nerve blockade has traditionally been employed to achieve acceptable analgesia. Recently, ultrasound-based studies have demonstrated that blind abdominal wall injections are done with poor accuracy. Ultrasound-guided alternatives, such as the transverses abdominis plane (TAP) block, may improve analgesic efficacy and patient comfort in the post-operative period when compared to blind landmark based nerve blockade. There has been increasing utilization of the TAP block in the adult population due to the described ability to provide effective blockade of the thoracolumbar spinal nerves innervating the abdominal wall. We propose a randomized prospective evaluation of the analgesic efficacy comparing surgeon performed ilioinguinal/iliohypogastric block with ultrasound-guided TAP blockade in healthy ASA I and II pediatric patients undergoing unilateral herniorrhaphy on an outpatient basis.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is male or female;
- •The subject is of any racial and ethnic groups;
- •The subject is age 12 months to 10 years (inclusive);
- •The subject weighs more than 8.0 kg (inclusive of the eighth kilogram);
- •The subject is scheduled for the following: Unilateral herniorrhaphy scheduled on an out-patient basis, and not being performed in conjunction with any other surgical procedures;
- •The subject is American Society of Anesthesiologists (ASA) patient classification I-II
- •The subject's legally authorized representative has given written informed consent to participate in the study and when appropriate, the subject has given assent or consent to participate.
排除标准
- •Additional surgical procedures are being performed concurrently;
- •The subject is ASA classification > II;
- •The subject has pre-existing allergies to local anesthetics;
- •The subject receives midazolam as a premedication;
- •The subject has an imminent life threatening condition that impacts the ability to obtain informed consent;
- •The subject has any other condition, which in the opinion of the principal investigator, would not be suitable for participation in the study.
研究组 & 干预措施
TAP Block
干预措施: TAP Block (Procedure)
Ilioinguinal/iliohypogastric blockade
干预措施: Ilioinguinal/iliohypogastric blockade (Procedure)
结局指标
主要结局
Efficacy Outcome
时间窗: Participants will be followed for the duration of post-anesthesia care unit stay, an expected average of 2 hours
Worst FLACC score observed in the post-anesthesia care unit by the research coordinator during the first post-operative hour
次要结局
- Confounding Variable - Length of time for TAP(participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours)
- Efficacy Outcome - Post-operative Calls(participants will be followed for 48 hours after procedure)
- Outcome Measure - Number of patients with post-operative complications(participants will be followed for 48 hours after procedure)
- Efficacy Outcome - Length of Recovery Room(participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours)
- Confounding Variable - Electrocautery(participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours)
- Confounding Variable - Surgical dissection(participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours)