Superficial Cervical Plexus Block for Improved Outcomes in Pediatric Otolaryngologic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Opioid use
研究概览
简要总结
Literature on the use of superficial cervical plexus blocks for ear surgery is sparse in general, and almost non-existent in the pediatric population. Overall, literature review supports the safety of performance of this block but there is minimal published literature on its utility despite anecdotal evidence of benefit. This study, especially its prospective randomized nature will allow for expansion of the evidence for or against addition of this block to the care of pediatric patients undergoing ear surgery. The purpose of this study is to determine if SCPB plus standard practices provides superior pain control, as measured by reduced opiate consumption, compared to standard practices alone when performed on pediatric patients undergoing surgery on the ear and mastoid process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •Age: <18 years and >3 months
- •Surgical procedure: Unilateral cochlear implant or tympanomastoidectomy
排除标准
- •Preoperative opiate use within the last 30 days
- •Bilateral surgery
- •No English speaking caregiver
- •Parental/patient refusal
- •Severe preoperative respiratory compromise
- •Allergy to ropivacaine
- •Coagulopathy: Defined by INR>1.5 or Platelet count <100k
- •Current Infection at site of injection
- •VP Shunt on side of surgical procedure
- •Pregnant patients: determined by patient history and available laboratory data. Patients will not be required to have pregnancy testing done if not otherwise indicated.
研究组 & 干预措施
Group 2
干预措施: Saline (Drug)
Group1
干预措施: ropivacaine (Drug)
结局指标
主要结局
Opioid use
时间窗: 30 days post surgery
measured on a MME per kilogram
次要结局
- post-operative opiate use(30 days post surgery)
- Pain level(30 days post surgery)
- Post Anesthesia Care Unit anti-emetic use(30 days post surgery)
- intraoperative opiate use(30 days post surgery)
- Quality of Recovery(30 days post surgery)