Ultrasound Guided Serratus Anterior Plane Block Versus Standard Therapy for Analgesic Relief of Rib Fractures in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual Analog Pain Score (VAS) at 2 hours
研究概览
简要总结
This study is a single center, randomized controlled trial examining the effect of serratus anterior plane block (SAPB) on pain, PIC scores and other clinical outcomes in emergency department patients with multiple rib fractures in comparison to the use of analgesic medication alone.
Objectives
- Compare SAPB performed in the ED setting to analgesic medication alone with regard to pain, respiratory status and PIC score of patients with multiple rib fractures.
- Assess the safety and feasibility of performing ultrasound-guided SAPB in the ED.
- Evaluate outcomes of patients receiving the SAPB in the ED including amount of analgesic medications used, level of care required, need for upgrading level of care, and length of stay.
详细描述
Background Rib fractures are a common injury encountered in the emergency department (ED) affecting an estimated 10% of all trauma patients. They are associated with significant morbidity and mortality, especially in elderly patients. Rib fractures are the leading indication for intensive care unit (ICU) admission in patients with traumatic injuries to the thorax, accounting for approximately 42% of patients who require critical care in trauma. Secondary complications from rib fractures include atelectasis, pneumonia, and acute respiratory distress syndrome. These complications are often attributed to a relative respiratory functional deficit secondary to pain which limits adequate inspiratory capacity and coughing; therefore, the management of acute rib fractures has largely been focused on controlling pain. The most common method of pain control employed in the ED has historically been the use of a multimodal analgesic approach which includes opioids, acetaminophen, and NSAIDS. Opioids confer additional risks which include respiratory depression, suppressed cough reflex, delirium, nausea, constipation, and the potential for addiction.
Ultrasound-guided serratus anterior plane block (SAPB) is an alternative method of pain control that utilizes targeted delivery of a local anesthetic agent in the serratus anterior fascial plane. This method was first described in 2013 and has been well described for the treatment of pain associated with thoracic surgical procedures, including those of the breast and chest wall. The SAPB has also been demonstrated to provide analgesic relief of pain associated with rib fractures and other blunt chest-wall traumatic injuries.
Over recent years, the SAPB technique has been gaining popularity due to its efficacy, relative ease of performance, and favorable side effect profile. This ultrasound guided technique uses a high frequency linear ultrasound transducer to identify the serratus anterior fascial planes, latissimus dorsi muscle, ribs, and pleural space. The intended target is the superficial serratus anterior fascial plane, which is bordered by the latissimus dorsi muscle posteriorly and the pectoralis muscles anteriorly. This fascial plane houses the lateral cutaneous branches of the intercostal nerves and a plane block of the superior facial plane has also been postulated to provide analgesia in the distribution of the long thoracic and thoracodorsal nerves. The block primarily works at the level of T2-T9, and previous literature has suggested that the SAPB works best for anterolateral rib fractures. The SAPB has a relatively safe side effect profile. Major complications include pneumothorax and local anesthetic systemic toxicity (LAST); however, the incidence of adverse events following SAPB performed in the ED has been low in previous studies.
Point of care ultrasound (POCUS) for procedural guidance is commonly employed by emergency physicians in daily clinical practice. Several retrospective and case-series studies have demonstrated the efficacy, feasibility, and safety of SAPB in the ED when performed by trained ED physicians. Studies like those performed by Diwan et al. and Kring et al. have demonstrated improved pain scores and decreased opioid consumption following SAPB. Despite this, to date, there has only been one published randomized controlled trial comparing the analgesic effects of SAPB versus opioid pain medication. More data is needed to further evaluate the analgesic effect of ED performed SAPB and the outcome of patients who present with acute rib fractures.
The Pain, Inspiratory capacity, and Cough (PIC) score is a tool currently utilized in blunt chest trauma cases at WellSpan York Hospital to guide inpatient management and predict the need for escalating care. This ten-point scoring tool accounts for the patient's pain level (mild/moderate/severe), inspiratory capacity (percent predicted value), and cough effort, with a goal score of >8. Inspiratory capacity and cough effort are often directly related to the level of pain a patient is experiencing, therefore, improving rib fracture pain through SAPB may improve PIC scores and help reduce the need for intensive care unit (ICU) level care. Additionally, analgesic relief with SAPB should decrease opioid consumption and its associated risks in the immediate period following rib fractures.
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
- 否
入选标准
- •Age >18 years
- •>1 Unilateral, acute rib fractures diagnosed on x-ray or CT imaging
- •Patient presenting to the WellSpan York Hospital ED
- •Patient requiring IV analgesia or oral opioid to control pain related to rib fractures
排除标准
- •Age <18 years
- •Inability to provide informed consent
- •Allergy to local anesthesia
- •Subsequent visit for rib fractures
- •Patients taken emergently to the OR or discharged from the ED
- •Significant distracting injuries/polytrauma that would not be expected to be responsive to analgesia from SAPB and confound pain scores, i.e. long bone fractures, intraabdominal injuries, etc.
研究组 & 干预措施
Serratus Anterior Plane Block
Subjects will undergo serratus anterior plane block, in addition to standard of care analgesic medications at the discretion of the treatment team.
干预措施: Serratus Anterior Plane Block (SAPB) (Procedure)
Serratus Anterior Plane Block
Subjects will undergo serratus anterior plane block, in addition to standard of care analgesic medications at the discretion of the treatment team.
干预措施: Standard Analgesic Medications (Drug)
Standard Analgesic Medications
Subjects will receive standard of care analgesic medications at the discretion of the treatment team.
干预措施: Standard Analgesic Medications (Drug)
结局指标
主要结局
Visual Analog Pain Score (VAS) at 2 hours
时间窗: 2 hours
Change in pain score on a visual analog scale (VAS) at 2 hours following randomization to ultrasound guided SAPB or analgesic medication only.
次要结局
- Rate of ICU Utilization(From date of randomization until the date of discharge from the hospital or death from any cause, whichever came first, assessed up to 100 months)
- Morphine Milligrams Equivalent (MME)(2 hours, 4 hours, 6 hours, 8 hours and 12 hours following randomization)
- Pain Score(4 hours, 6 hours, 8 hours, and 12 hours following randomization)
- Length of Stay (hours)(During index hospitalization following randomization)
- Pain/Inspiratory Effort/Cough (PIC) Score(4 hours, 6 hours, 8 hours, and 12 hours following randomization)
- Rate of Crossover(From date/time of randomization until the date/time of departure from the ED or death from any cause, whichever came first, assessed up to 24 hours)
研究者
Daniel Kreider
Associate Director of Emergency Ultrasound, Principal Investigator
WellSpan Health
