The Erector Spinae Plane Block and Its Effect on Respiratory Status and Pain Management in Rib Fracture Patients
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Change in numeric pain score rating with respiration (after incentive spirometry exercise)
研究概览
简要总结
The purpose of this research study is to identify the benefits of a type of nerve block, called an erector spinae plane block (ESP), in the treatment of patients with multiple rib fractures and uncontrolled pain despite receiving current institutional standards of care.
详细描述
Rib fractures are one of the most common injuries secondary to blunt chest trauma, and carry significant risk in terms of patient morbidity and mortality. Pulmonary complications resulting from these injuries include severe atelectasis with hypoxemia, pneumonia, pleural effusions, respiratory distress syndrome, need for mechanical ventilation and ICU admission, and prolonged hospital stay. Many institutions have tried to develop protocols to risk stratify and appropriately treat these patients, with the goal of predicting those with higher likelihood of pulmonary complications in order to minimize additional morbidity. Studies have demonstrated critical spirometry values which correlate to worse patient outcomes; specifically, vital capacity less than 50% predicted, or less than 2L. Subsequently, there have been numerous attempts to identify the best treatment interventions for these high risk patients. In addition to multi-modal pain management, the most commonly used procedures include thoracic epidurals, continuous or single shot paravertebral blocks, and intercostal blocks. However, all of the above interventions carry significant risk, and the frequent use lovenox thromboprophylaxis drastically limit their use. Recently, a novel peripheral nerve block technique has been developed, an erector spinae plane block (ESP), which may provide similar or greater efficacy to the above, with significantly less risk to the patient.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Blunt chest trauma
- •Sustaining at least 3 unliateral rib fractures
- •Resultant vital capacity less than 30% predicted
- •Pain score reaches threshold despite using the current institutional standard of care for pain control
排除标准
- •Patients whose weight less than 60kg.
- •Patients with bilateral rib fractures.
- •Patients that are intubated and mechanically ventilated.
- •Pregnant Individuals.
- •Any individual with a documented allergy to ropivacaine.
- •Patients with limited English proficiency (LEP)
- •Patients whose body habitus prevents the practitioner's ability to adequately perform the procedure.
研究组 & 干预措施
ESP block with normal saline
An erector spinae plane block will be performed and a single dose of Normal Saline Flush, 0.9% Injectable Solution will be administered into the target muscle plane.
干预措施: Normal Saline Flush, 0.9% Injectable Solution (Drug)
ESP block with local anesthetic
An erector spinae plane block will be performed and a single dose of 0.5% ropivacaine will be injected into the target muscle plane.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Change in numeric pain score rating with respiration (after incentive spirometry exercise)
时间窗: Baseline and at 45 minutes after ESP block
Self-reported pain intensity before the ESP block is performed and after the ESP block is performed. These measurements will be assessed after the incentive spirometry exercise. Each item is scored 0-10 (0 = no pain; 10 = worst pain possible)
Change in numeric pain score rating at rest (before incentive spirometry exercise)
时间窗: Baseline and at 45 minutes after ESP block
Self-reported pain intensity before the ESP block is performed and after the ESP block is performed. These measurements will be assessed before the incentive spirometry exercise. Each item is scored 0-10 (0 = no pain; 10= worst pain possible)
Change in incentive spirometry values
时间窗: Baseline and at 45 minutes after ESP block
Incentive spirometry values, measured in cubic centimeters, when the participant provides one inhalational breath at maximum effort. The first measurement will be taken before the ESP block procedure and the second measurement 45 minutes after the ESP block procedure.
次要结局
未报告次要终点
