Ultrasound-guided Rectus Sheath Block for Post-operative Pain Control Following Umbilical Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- pain scores
研究概览
简要总结
The purpose of this study is to compare the effectiveness of local infiltration to an ultrasound guided nerve block placed by the anesthesiologist for children undergoing umbilical hernia repair.
This is a double-cohort, double blinded, randomized study comparing local infiltration to ultrasound-guided rectus sheath block in children 1 to 17 years of age undergoing epigastric or umbilical hernia repair.
We will first compare pain scores to see if one method is more adequate then the other in providing post-op analgesia. Our second aim is to compare morphine consumption between the two groups.
Our third aim is to measure the levels of local anesthetic in the blood following local anesthetic infiltration or USGRSB.
详细描述
Healthy children, aged 1 to 17 years of age, undergoing elective umbilical hernia repairs will be considered for this study. After informed consent/assent has been obtained, the subject will be randomized into one of two groups. Group A will receive local infiltration of 0.25% bupivacaine by the surgeon at the end of the subject's surgery. Group B will undergo an ultrasound-guided rectus sheath block using 0.25% bupivacaine prior to incision by an anesthesiologist skilled in the performance of this block.
All subjects will receive a standardized anesthetic for their surgery. Subjects assigned to Group A (local infiltration) will receive 2mcg/kg of fentanyl prior to incision for intra-operative pain management. Subjects assigned to Group B will have their Rectus Sheath Block and no fentanyl will be given at this time.
Fentanyl is a short-acting opioid analgesic. It's duration of action in the dose we will be using is approximately one hour which is close to the expected length of surgery. Therefore, it is not expected to influence the pain management after surgery.
Pain scores will be assessed by a member of the research team. They will be blinded to which technique the subject has been randomized to. This person will not be involved in the direct care of the subject. These observations will be made using an age-appropriate scoring system (FLACC or FACES scale). Scoring will be done every 5 minutes when the subject is in the recovery room and every 30 minutes when they are in Phase II. This will be done until the subject is discharged from the hospital.
Families will be followed by phone for 48 h post discharge, to collect data on medication use.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between 1 ≤ 17 years of age
- •ASA I (normal healthy children) and II (Children with mild systemic disease that has no functional effects)
- •Having elective umbilical hernia repair
排除标准
- •Children < 1 year of age or > 17 years of age
- •Family has no telephone for follow up phone call
- •Allergy or sensitivity to bupivacaine or morphine
- •Any coagulation abnormalities
- •Emergency surgery
结局指标
主要结局
pain scores
时间窗: 4 hours
次要结局
- morphine consumption(4 hours)
- plasma bupivacaine levels(0, 10, 20, 30, 45, 60 minutes after injection)
研究者
Sean Flack
Principal Investigator
Seattle Children's Hospital