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



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:9/2/2018
Start Date:August 29, 2018
End Date:August 1, 2020
Contact:Chadrick R Evans, MD
Email:cevans@peoriasurgical.com
Phone:309-655-2383

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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

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

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

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:

1. Intracranial hemorrhage

2. Fever >101 degrees Fahrenheit for ≥ 1 hour(s)

3. Rash at site of catheter insertion or administration of nerve block

4. Hemodynamic instability

5. Spinal cord injury

6. Vertebral fractures

7. Allergy to bupivacaine

8. Systemic therapeutic anticoagulation required for duration of hospital admission
20

9. Altered mental status without medical decision maker to provide consent

10. Patients without the capacity to consent or the lack of a medical decision maker
to consent

11. Patients that are pregnant

12. Legally confined patients.
We found this trial at
1
site
530 NE Glen Oak Ave
Peoria, Illinois 61637
(309) 655-2000
Phone: 309-655-3971
OSF St. Francis Medical Center OSF Saint Francis Medical Center, licensed for 616 beds and...
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mi
from
Peoria, IL
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