Non- Inferiority Study of Erector Spinae Plane Block Compared to Thoracic Epidural Analgesia in Multimodal Pain Management of Multiple Rib Fractures
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- MRF pain at rest and with cough before and after TEA or ESPB placement using the pain visual analog scale (VAS) for pain in the thorax/ribs.
研究概览
简要总结
The purpose of this study is to compare 2 pain control treatments for people with 3 or more rib fractures.
详细描述
2.1 Primary Objective
- Compare efficacy of ESPB to TEA for MRF analgesia.
2.2 Secondary Objective
- Compare systemic opioid and non-opioid medication use in patients with ESPB and TEA.
2.3 Tertiary/Exploratory/Correlative Objectives
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •Radiological evidence of 3 or more rib fractures
- •Within 48 hours of admission to hospital with rib fractures
- •Can actively participate by answering questions during TEA or ESPB placement
- •Moderate-severe (4-10 out of 10) pain at the time of enrollment
排除标准
- •Greater than 48 hrs since admission to the hospital with rib fractures
- •Patient refusal
- •Infection at the site of TEA or ESPB insertion
- •Allergy to local anesthetics
- •Depth from skin to catheter placement target 6 or more centimeters
- •Greater than 7 consecutive ribs involved on each side
- •Other regional or epidural block already received
- •Unable to follow commands/altered mental status
- •Sepsis (temperature > 38 degrees Celsius & positive blood cultures)
- •Elevated intracranial pressure (ICP > 12 mm Hg)
- •Coagulopathy (INR > 1.4) or recent therapeutic anticoagulant use (varies with which medication the patient is on)
- •Preexisting central nervous system disorders, such as multiple sclerosis
- •Thrombocytopenia (Platelets <70,000)
- •Spine fracture or previous back surgery
- •Preload dependent states (aortic stenosis, hypertrophic obstructive cardiomyopathy)
- •Aortic transection
- •Hemodynamic instability (patients with MAPs <60 and/or patients requiring pressor support)
- •Tattoo at sight of catheter placement
研究组 & 干预措施
ESPB Group
20ml Ropivacaine is injected near the nerves in the back and then continued using an infusion pump.
干预措施: ESPB (Procedure)
TEA Group
5ml Bupivacaine is injected into the space around the spinal cord and then continued using an infusion pump.
干预措施: TEA (Procedure)
结局指标
主要结局
MRF pain at rest and with cough before and after TEA or ESPB placement using the pain visual analog scale (VAS) for pain in the thorax/ribs.
时间窗: 72 hours after catheter placement
Participants will be asked about their rib pain specifically during this assessment along with the maximum pain experienced and its location. VAS is used to measure pain on a scale of 1-10, with 1 being the least and 10 being the most amount of pain.
MRF pain at rest and with cough before and after TEA or ESPB placement using the pain visual analog scale (VAS) for pain in the thorax/ribs.
时间窗: 24 hours after catheter placement
Participants will be asked about their rib pain specifically during this assessment along with the maximum pain experienced and its location. VAS is used to measure pain on a scale of 1-10, with 1 being the least and 10 being the most amount of pain.
次要结局
- Determine total systemic opioid and non-opioid medication use in patients with ESPB and TEA by reviewing patient EMR.(After patient discharge up to 7 days)
研究者
Ross Mirman
Assistant Professor of Clinical Anesthesia
Indiana University