Protocol for a Single Center Randomized Controlled Trial of Liposomal Bupivacaine Intercostal Nerve Blockade Versus Continuous Thoracic Epidural for Regional Analgesia in Patients With Multiple Rib Fractures
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Change in pain relief
研究概览
简要总结
Management of traumatic rib fractures continues to be a challenge for trauma surgeons. Currently, many analgesic options are available to patients suffering from rib fractures. Formulations currently used for conventional intercostal nerve blocks (CINB) are relatively safe, do not require additional equipment or specialized anesthesia personnel, do not require catheter repositioning, and provide improved analgesia immediately over the aforementioned systemic therapies. A goal of these authors to introduce an additional safe option for extended local analgesia in the setting of multiple rib fractures given the inconclusive evidence supporting or refuting the current standard of care
详细描述
The objective of this study is to quantify and draw inferences on the efficacy of a multiple level liposomal bupivacaine intercostal nerve blockade (LBINB) in patients with multiple traumatic rib fractures.
The primary objective is to assess the quality and duration of analgesia based on numeric grading pain scale, improvement in pulmonary function parameters, reduction pulmonary complications, and duration of hospitalization in patients receiving LBINBs relative to those receiving the current standard of care, CEA, in patients recovering from multiple traumatic rib fractures.
The secondary objective of this study is to assess cost and rate of complications associated with LBINB relative to CEA.
This is a two arm, randomized trial. Patients suffering multiple traumatic rib fractures will be offered CEA or LBINB. As the current standard of care, CEA will serve as the control, and outcomes measured in patients receiving LBINB will be statistically evaluated relative to the CEA control group.
All patients will receive standardized NSAID and opioid analgesia protocol for break through pain, as well as standardized routines for pulmonary hygiene and physiotherapy.
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
盲法说明
No participants are blinded to treatment arms. Patients and investigators are aware of which patients are assigned to each treatment group.
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
- •All patients 18 years of age or older suffering 3 or more rib fractures treated by University of Illinois College of Medicine at Peoria (UICOMP) attending or resident physicians at OSF St. Francis Medical Center (OSFMC) are potentially eligible for enrollment in the trial.
排除标准
- •Patients with any of the following will not be eligible since they are contraindications to CEA, LBINB, or both:
- •Intracranial hemorrhage
- •Fever >101 degrees Fahrenheit for ≥ 1 hour(s)
- •Rash at site of catheter insertion or administration of nerve block
- •Hemodynamic instability
- •Spinal cord injury
- •Vertebral fractures
- •Allergy to bupivacaine
- •Systemic therapeutic anticoagulation required for duration of hospital admission 20
- •Altered mental status without medical decision maker to provide consent
- •Patients without the capacity to consent or the lack of a medical decision maker to consent
- •Patients that are pregnant
- •Legally confined patients.
研究组 & 干预措施
Bupivacaine Liposome Injection [Exparel]
Patients will receive a nerve block with a medication called liposomal bupivacaine, also called Exparel. Once assigned, a University of Illinois surgeon, or resident surgeon, will administer the nerve block. The nerve block is expected to provide pain relief from 72 to 96 hours. During this time, patients may request oral or intravenous pain medication for breakthrough pain. Patients will remain in the hospital until discharged by the attending physician.
干预措施: Bupivacaine Liposome Injection (Drug)
Epidural 0.125% bupivicaine
Patients will receive pain relief through a 0.125% bupivacaine epidural in the upper back by an assigned anesthesiologist. This epidural will remain in place for an uncertain amount of time. The decision to remove the epidural will be determined by the physicians and will be based on level of pain and injury.
However, pain data will only be recorded by the research team for no longer than 96 hours after the epidural is placed. Patients are able to request intravenous and oral pain medications for breakthrough pain. After the epidural is removed, they will remain in the hospital until discharged by the attending physician.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Change in pain relief
时间窗: 96 hours
Quality of analgesia provided measured by numeric grading pain scale assessment every 24 hours over a 96-hour period. Pain will be rated using the Numerical Rating Scale, ranging from 0-10. Zero represents "no pain"; worsening pain signified by increasing reported numbers with 10 being the upper limit and the "worst pain possible". Only the numbers can be answers, meaning that there are only 11 possible answers on the 0-10 scale.
次要结局
- Length of pain medication(every 24hours for 96hours)
- Pulmonary function(96 hours)
- Oxygen saturation(96 hours)
- Quantity of pain medication(96 hours)
- Supplemental oxygen(96 hours)
- Pulmonary complications(96 hours)
- Ventilator(96 hours)
- ICU stay(96 hours)
- Costs(96 hours)
- Overall length of stay(96 hours)
- Overall complication rate(96 hours)
研究者
Chadrick Evans
Director of Surgical ICU and Trauma
OSF Healthcare System