Continuous Erector Spinae Plane Blocks for Analgesia and Improving Incentive Spirometry Following Traumatic Rib Fractures
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Maximal Inspired Volume - Absolute
研究概览
简要总结
Rib fractures are one of the most common injuries in trauma patients. These fractures are associated with significant pain as well as decreased ability to inspire deeply or cough to clear secretions, which together lead to complications of the lungs and breathing which leads to risks of further injury and even death.
One recent study found that the ability to move air into and out of the lungs practically doubled with the administration of a single-injection Erector Spainae Plane Block (ESPB) while pain levels nearly halved. However, a single-injection nerve block lasts less than 24 hours while a perineural local anesthetic infusion (also termed a "continuous peripheral nerve block") may be administered for multiple days. This entails inserting a tiny tube through the skin and into the area around the nerves, after which more local anesthetic may be administered prolonging the numbing effects.
The possibility of extending the duration of a ESPB with local anesthetic administration via a perineural catheter has not be investigated. We therefore are conducting a randomized, triple-masked, placebo-controlled, parallel-arm study to investigate the addition of a continuous ESPB to a single-injection ESPB following traumatic rib fractures.
The primary outcome of this study will be the maximum inspired volume measured by incentive spirometry on the afternoon following the nerve block procedure. We hypothesize that the maximum inspired volume will be significantly increased in the afternoon following the procedure with the addition of a continuous ESPB to a single-injection ESPB.
详细描述
Rib fractures are one of the most common injuries in trauma patients. These fractures are associated with significant pain as well as decreased ability to inspire deeply or cough to clear secretions, which together lead to complications of the lungs and breathing which leads to risks of further injury and even death.
The erector spinae plane block (ESPB) is a nerve block that covers multiple rib fractures with a single injection. This block entails injecting local anesthetic in the back superficial to the vertebral bodies. One study found that the ability to move air into and out of the lungs practically doubled with the administration of a single-injection ESPB while pain levels nearly halved.
A single-injection nerve block lasts less than 24 hours while a perineural local anesthetic infusion (also termed a "continuous peripheral nerve block") may be administered for multiple days. This entails inserting a tiny tube through the skin and into the area around the nerves, after which more local anesthetic may be administered prolonging the numbing effects. The possibility of extending the duration of a ESPB with local anesthetic administration via a perineural catheter has not be investigated.
We therefore are conducting a randomized, tripe-masked, placebo-controlled, parallel-arm study to investigate the addition of a continuous ESPB to a single-injection ESPB following traumatic rib fracture. Subjects will be individuals who present with rib fracture(s) and significant pain. Those who consent to participate in this study will have an ESP catheter inserted using ultrasound-guidance on the ipsilateral side at the level of the inferior-most fracture. For bilateral fractures, a second catheter will also be inserted on the remaining side. The single-injection ESPB will be administered to each catheter with 20 mL of ropivacaine 0.5% (with epinephrine).
Subjects with an accurately-inserted catheter based on visualization of local anesthetic spread will be allocated to one of two possible perineural treatments stratified by unilateral vs. bilateral fractures (1:1 ratio in blocks of 2):
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)
盲法说明
Study solution containing either local anesthetic (ropivacaine) or saline will be prepared by the UCSD Investigational Drug Study Service. Both ropivacaine and normal saline are clear and indistinguishable visually.
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
- •having a total of 1-6 rib fractures at least 3 cm distal to the costo-transverse joint (bilateral fractures are acceptable, but the total of the two sides combined must not exceed 6 fractures)
- •regional anesthetic requested by the admitting service
- •patient accepting of a perineural catheter insertion and subsequent study fluid treatment.
排除标准
- •chronic opioid use (daily use within the 2 weeks prior to presentation and duration of use > 4 weeks; of note, any testing for opioid use will not occur as part of the study, but may as standard of care)
- •pregnancy
- •incarceration
- •inability to communicate with the investigators
- •weight < 45 kg or morbid obesity (body mass index > 40 kg/m2)
- •comorbidity precluding either perineural catheter insertion or subsequent ambulatory perineural local anesthetic administration (e.g., current infection at the catheter insertion site, known hepatic or renal insufficiency, immune-compromised status of any etiology)
- •any patient unable to correctly perform incentive spirometry as this is the primary outcome measure
- •any patient with any degree of decreased mental capacity as determined by the surgical service
- •any reason an investigator believes study participation would not be in the best interest of the potential subject
- •flail chest
- •chest tube
- •fracture of the 1st rib on either side
- •any injury other than the rib fracture(s) that potentially effects inspiratory effort or volume (e.g., clavicle fracture)
- •inability to contact the investigators during the perineural administration, and vice versa (e.g., lack of telephone access).
研究组 & 干预措施
Active Treatment
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of ropivacaine 0.3% (continuous block)
干预措施: Active ropivacaine 0.3% erector spinae plane perineural administration (Drug)
Placebo
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of normal saline
干预措施: Placebo erector spinae plane perineural administration (Drug)
结局指标
主要结局
Maximal Inspired Volume - Absolute
时间窗: Between 1200 and 1700 on the day following the procedure
Measured via a handheld incentive spirometer. The best of three measurements will be recorded as the maximum inspired volume.
次要结局
- Brief Pain Inventory (Short Form, Interference Subscale)(Months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure)
- Maximal Inspired Volume - Absolute(Afternoons on postoperative days 2 and 7, postoperative months 0.5, 1, 1.5, 2, 3, 6, and 12)
- Maximal Inspired Volume - Percentage Change From Baseline Prior to Intervention(Afternoons on postoperative days 1, 2 and 7, postoperative months 0.5, 1, 1.5, 2, 3, 6, and 12)
- WORST Rib Fracture Pain in Previous 24 Hours(Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure)
- Opioid Consumption(Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure)
- LEAST Rib Fracture Pain in Previous 24 Hours(Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure)
- AVERAGE Rib Fracture Pain in Previous 24 Hours(Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure)
- Rib Fracture Pain When Using an Incentive Spirometer(Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure)
- CURRENT Rib Fracture Pain in Previous 24 Hours(Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure)
- Sleep Disturbances Due to Rib Fracture Pain(Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedure)
研究者
Brian M. Ilfeld, MD, MS
Professor in Residence
University of California, San Diego