Ultrasound Guided Emergency Physician Performed Erector Spinae Nerve Block for Rib Fracture Analgesia
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 72
- 主要终点
- Total intravenous (IV) and oral narcotic analgesic use
研究概览
简要总结
The study will be a prospective randomized double blinded placebo controlled clinical trial using ultrasound guided erector spinae plane block as an analgesic adjunct among adult emergency department (ED) patients with rib fractures using mean morphine milligram equivalents as the primary outcome.
详细描述
Aim 1: Given the novelty of the erector spinae plane nerve block and limited data from anesthesia literature, aim 1 is to obtain preliminary data regarding quantity of mean morphine equivalents received by control and experimental groups for an initial subset of 50 patients to improve sample size calculation and better power the study.
Aim 2: Evaluate efficacy of ED performed ultrasound guided ESP block in delivering analgesia by evaluating difference in morphine milligram equivalents (MME) as well as pain scores during ED stay and hospital admission between the experimental and control groups.
Aim 3: Evaluate adverse event rates related to ultrasound guided ESP block placement as well as rates of rib-fracture related complications between control and experimental groups.
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
- Double (Participant, Care Provider)
盲法说明
The clinical team taking care of the patient as well as the patient will be blinded as to allocation to experimental or control group. The physician administering the block will also be blinded to the substance administered.
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
- •radiographic evidence of unilateral rib fracture(s).
- •able to consent and actively participate in the study.
- •moderate to severe pain (defined as numerical pain rating score >/ 4 ) at time of enrollment.
排除标准
- •known allergy or hypersensitivity to local anesthetics or morphine.
- •infection at site of ESP block placement.
- •depth over 5 cm from skin to transverse process visualized with ultrasound.
- •additional injuries that preclude positioning for ESP block placement.
- •severe traumatic brain or spinal cord injury.
- •severe altered mental status, such that pain could not be assessed.
- •extra thoracic injuries for which rib pain is reported as less than the rest of the injuries.
- •adjunctive epidural catheter pain control.
- •other regional anesthetic blocks.
- •pregnancy or prisoner status.
- •unstable vital signs.
研究组 & 干预措施
erector spinae plane block (ESP block) with bupivacaine
Each participant randomized to the ESP block group will receive an ultrasound guided single shot injection of 20cc of 0.25% bupivacaine in the plane between the transverse process of the spine and the erector spinae muscle.
干预措施: ESP block with bupivacaine (Drug)
ESP block with saline/sham injection
Each participant randomized to the ESP block group will receive an ultrasound guided single shot injection of 20cc of normal saline in the plane between the transverse process of the spine and the erector spinae muscle.
干预措施: Saline control/sham injection (Other)
结局指标
主要结局
Total intravenous (IV) and oral narcotic analgesic use
时间窗: From enrollment/baseline in the study through the study period, up to 24 hours.
narcotic use will be measured in morphine milligram equivalents (MME), based on dosing and frequency.
次要结局
- Total non-narcotic analgesic use.(From enrollment/baseline in the study through the study period, up to 24 hours.)
- Hospital length of stay (LOS)(From hospital admission to hospital discharge, up to 30 days.)
- Number of Patients Who Develop Pneumonia(From admission to 30 days from admission.)
- Pain score(24 hours post-baseline)
- Adverse events associated with the nerve block itself.(Within two hours of administration of the nerve block.)