A Pilot Study Comparing Three Analgesia Approaches for Rib Fractures
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Opioid Use in oral morphine equivalents (OME)
研究概览
简要总结
This study will be a 3-arm, parallel-group, randomized controlled trial comparing three analgesic techniques for rib fractures with a sample size of 24 patients (8 per group). Patients will be randomly assigned to one of the following three groups: 1) ESP block with catheter using ropivacaine (bolus followed by continuous infusion); 2) lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h; or 3) standard care with multimodal analgesia and opioids.
Our specific aims are:
- To compare the opioid use and pain ratings over the first 72 hours after enrollment.
- To quantify the changes in vital capacity, oxygen requirement, and freedom from mechanical ventilation that result from the intervention.
- To explore the impact of ESP blocks and lidocaine infusions on the development of chronic pain and post-discharge opioid use (exploratory).
Inclusion Criteria:
• Adult patients ≥ 55 years old who have sustained 3 or more unilateral rib fractures and are admitted to the hospital.
Exclusion Criteria:
- Allergy to amide local anesthetics, lidocaine, or ropivacaine
- Pregnancy
- Bilateral rib fractures
- Coagulopathy (INR > 1.5; PTT > 1.5 times ULN, or platelets < 75,000)
- Conduction block on EKG
- Total body weight < 40 kg
- Painful distracting injuries: acute thoracic spine fracture, severe traumatic brain injury or spinal cord injury, unstable pelvic fracture, open abdomen
- Spine fracture at the level of intended ESP block
- Infection near the ESP insertion site or active bacteremia or sepsis
- Any patient deemed a poor candidate for ESP block and/or lidocaine infusion will also be excluded
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
- Single (Outcomes Assessor)
盲法说明
Participants, care providers, and investigators will not be blinded but outcome assessors will be unaware of group assignment when doing baseline assessments and when performing some post-randomization assessments, such as those at 30 and 90 days by phone call.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 55 years old
- •Sustained 3 or more unilateral rib fractures and are admitted to the hospital
排除标准
- •Allergy to amide local anesthetics or any study medications
- •Pregnancy
- •Bilateral rib fractures
- •Coagulopathy (INR > 1.5; platelets < 100,000)
- •Conduction block on EKG
- •Spine fracture at the level of intended ESP block
- •Infection near the ESP insertion site or active bacteremia or sepsis
- •Any patient deemed a poor candidate for ESP block and/or lidocaine infusion will also be excluded
研究组 & 干预措施
ESP block with catheter using ropivacaine (bolus followed by continuous infusion)
干预措施: ESP block with catheter using ropivacaine (bolus followed by continuous infusion) (Procedure)
Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h
干预措施: Lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h (Drug)
结局指标
主要结局
Opioid Use in oral morphine equivalents (OME)
时间窗: 72 Hours
This will include both IV and oral opioids. Opioids given via PCA will also be prospectively recorded and included.
Brief Pain Inventory - current pain subscale (0-10)
时间窗: 0-72 Hours
The Brief Pain Inventory (short form) - average of all "current pain" ratings).
次要结局
- Brief Pain Inventory(Day 90)
- Daily opioid use(30 Days)
- Daily opioid Use(90 Days)
- Vital capacity (mL)(Day 3)
- Duke Activity Status Index(Baseline prior to intervention)
- Short-form 12(Day 90)
- Respiratory depression(Days 1-3)
- Epidural eligibility(Day 1)
- 3D-CAM/CAM-ICU(Day 3)
- Presence of perioral numbness(Day 3)
- RibScore(Day 1)
- Presence of metallic taste(Day 3)
- Presence of tinnitus(Day 3)