Liposomal Bupivacaine Intercostal Nerve Block vs Thoracic Epidural for Regional Analgesia in Multiple Rib Fractures

Study Overview
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Brief Summary
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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

Detailed Description
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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. Indications for CEA and LBINB in this study include patients suffering from traumatic thoracic injury with greater than or equal to 3 fractured ribs

Official Title
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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

Conditions
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Trauma, Trauma Injury, Pain, Acute

Intervention / Treatment
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* Drug: Bupivacaine Liposome Injection
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Patients with any of the following will not be eligible since they are contraindications to CEA, LBINB, or both: Intracranial hemorrhage Fever &gt;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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine Liposome Injection [Exparel]<br>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. | Drug: Bupivacaine Liposome Injection<br>* Under ultrasound guidance, corresponding ribs will be identified. 3-5 ml of a 1.3% (13.3 mg/mL) of liposomal bupivacaine will be drawn into a syringe with a 1.5-in, 22-gauge needle. The needle will then be advanced 20° cephalad to the skin 3-4 cm lateral to midline at the level of each fractured rib, and 1-2 ribs levels above and below injury. The needle will be advanced 3 mm below the inferior margin of the rib, placing the tip in the space containing the neurovascular bundle. Following negative aspiration for blood or air, 3-5 mL of local anesthetic will be infused and the needle withdrawn. No more than 266 mg, or 20 ml, of the 1.3% (13.3 mg/mL) liposomal bupivacaine solution will be injected<br>* Other names: Exparel;|
| Active Comparator: Epidural 0.125% bupivicaine<br>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. | Drug: Bupivacaine<br>* The anesthesia department will manage CEA. If possible, the patient will be in the sitting position. The skin will be prepped with chlorhexidine and sterilely draped. 3 mL of lidocaine 1% will be infiltrated the closest interspace to the rib fractures between T4 -T12. A Touhy needle will be inserted, the epidural space identified by loss of resistance technique. An epidural catheter will then be inserted to a depth of 12cm. 3 mL of test solution with lidocaine 1.5% with epinephrine, 1:200,000 will be injected with continuous EKG and SpO2 monitoring. Delivery of a 0.125% bupivacaine solution be continuously infused and titrated based on the patient's clinical status<br>* Other names: bupivacaine Hcl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain relief | 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. | 96 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity of pain medication | Amount of breakthrough analgesia required in morphine equivalents | 96 hours | 
| Length of pain medication | Duration of analgesia provided measured by numeric grading pain scale assessment every 24hours. 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. | every 24hours for 96hours | 
| Pulmonary function | Pulmonary function measured by incentive spirometry | 96 hours | 
| Supplemental oxygen | Supplemental oxygen requirements | 96 hours | 
| Oxygen saturation | Oxygen saturation levels | 96 hours | 
| Pulmonary complications | Development of pulmonary complications: atelectasis, pneumonia, respiratory failure | 96 hours | 
| Ventilator | Ventilator days | 96 hours | 
| Overall length of stay | Length of stay | 96 hours | 
| ICU stay | Duration of ICU days | 96 hours | 
| Costs | Costs associated with administration of epidural vs exparel | 96 hours | 
| Overall complication rate | Overall rate of complications associated with epidural vs exparel | 96 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rib trauma, intercostal nerve block, liposomal bupivacaine