Vital Capacity in Ultrasound Guided Serratus Plane Block in Emergency Department Patients With Multiple Rib Fractures: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Pain Control
研究概览
简要总结
I. Background:
Patients with multiple rib fractures are challenging from both pulmonary and analgesia perspectives. Adequate pain management is essential in prevention of complications secondary to decreased inspiratory volume. Significant morbidity and mortality of rib fractures is secondary to severe pain that limits ribcage movement, decreases inspiratory volumes and causes inadequate cough. Decreased vital capacity predisposes patients to atelectasis, abnormal mucous clearance and pneumonia. The objective of this study is to assess the efficacy of the serratus anterior plane block (SAPB) in improvement of vital capacity in patients with multiple unilateral rib fractures when compared to conventional management with medications. Currently, evidence of efficacy of SAPB in managing pain secondary to multiple rib fractures is limited to case reports and series, none of which evaluate vital capacity.
II. Significance:
The findings of this study may indicate that SAPB is superior to pharmacological management in increasing vital capacity in patients with multiple unilateral rib fractures and suggest SAPB for first line therapy in patients with rib fractures. The findings may decrease the risk of pulmonary complications as well as the use of opiates in management of multiple rib fractures in the Emergency Department especially in patients with numerous comorbidities and contraindications to conventional treatment modalities. This study may support the need for training emergency medicine physicians in bedside SAPB in order to provide the optimal therapy for patient with multiple unilateral rib fractures.
III. Study Objectives:
The primary objectives are to evaluate whether ultrasound guided SAPB results in a greater improvement in percent predicted vital capacity compared to standard therapy with a sham injection. The investigators will also evaluate pain scores and the safety profile of the SAPB procedure compared to those receiving standard analgesia.
IV. Hypothesis:
The primary hypothesis is that SAPB is superior to sham injection in improving the percent of predicted vital capacity. The secondary hypothesis is that SAPB will have greater improvement in pain scores and have a superior safety profile compared to placebo injection.
详细描述
STUDY DESIGN
This is a single center prospective, randomized, blinded clinical trial with a convenience sample that will be conducted in the Emergency Department of an urban level I trauma center.
A. Identify and enroll all patients coming in to the ED patient with presumed or clinically apparent 2 or more unilateral rib fractures between T3 to T9, with a resting pain score of ≥5. All patients meeting exclusion criteria will be excluded.
B. Randomization procedure:
- Pharmacy will dispense 30mL of injectate which will be randomized in block of 10 to either the SAPB group (30mL of 0.25% bupivacaine with epinephrine) or sham group (30mL of normal saline).
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Presumed/Clinically apparent 2 or more acute unilateral rib fractures between T3-T9
- •Pain Score 5 or greater
排除标准
- •Penetrating trauma
- •Unable to give consent due to dementia or altered mental status
- •Unable to perform spirometry
- •Requiring immediate surgical intervention
- •Known allergy to amide-type local anesthetics
- •Signs of infection or laceration at injection site
- •Systolic BP <100 mmHg
- •History of chronic pain, chronic use of analgesics
- •History of substance abuse
- •Painful distracting injury (injury causing significant pain that distracts the patient from having reliable scoring of rib fracture pain, i.e. femur fracture, dislocated joint)
- •If patient received any other pain medication besides ketamine prior to the block
- •Only posterior rib fractures present
- •known allergy to acetaminophen
- •Known allergy to morphine sulfate
研究组 & 干预措施
serratus anterior plane block group
The injection of bupivicaine into the chest muscle is performed with an ultrasound machine which can see the needle as it enters the muscle. The skin is cleaned with a sterile solution and the needle is guided right next to the chest muscle where either the bupivicaine injected. After the injection, the needle is taken out.
干预措施: Acetaminophen (Drug)
serratus anterior plane block group
The injection of bupivicaine into the chest muscle is performed with an ultrasound machine which can see the needle as it enters the muscle. The skin is cleaned with a sterile solution and the needle is guided right next to the chest muscle where either the bupivicaine injected. After the injection, the needle is taken out.
干预措施: Bupivacain (Drug)
Placebo injection group
The injection of normal saline into the chest muscle is performed with an ultrasound machine which can see the needle as it enters the muscle. The skin is cleaned with a sterile solution and the needle is guided right next to the chest muscle where saline is injected. After the injection, the needle is taken out.
干预措施: Acetaminophen (Drug)
Placebo injection group
The injection of normal saline into the chest muscle is performed with an ultrasound machine which can see the needle as it enters the muscle. The skin is cleaned with a sterile solution and the needle is guided right next to the chest muscle where saline is injected. After the injection, the needle is taken out.
干预措施: Saline (Drug)
结局指标
主要结局
Pain Control
时间窗: 60 minutes
Pain score on 11 point Numeric Rating Scale ranging 0-10 with 0 being no pain, 5 being moderate pain, and 10 being very severe pain
次要结局
未报告次要终点
研究者
Antonios Likourezos
Research Manager
Maimonides Medical Center