Clinical trial NCT03574376: Liposomal Bupivacaine Intercostal Nerve Block vs Thoracic Epidural for Regional Analgesia in Multiple Rib Fractures
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Trauma
Trauma Injury
Pain, Acute
Keywords: Rib trauma, intercostal nerve block, liposomal bupivacaine
Lead sponsor: OSF Healthcare System
Sponsor class: OTHER
Collaborators: name: University of Illinois College of Medicine at Peoria
name: OSF Healthcare System
First posted: 2018-07-02
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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 \&gt;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.

Primary outcomes:
measure: Change in pain relief
timeFrame: 96 hours
Secondary outcomes:
measure: Quantity of pain medication
timeFrame: 96 hours
measure: Length of pain medication
timeFrame: every 24hours for 96hours
measure: Pulmonary function
timeFrame: 96 hours
measure: Supplemental oxygen
timeFrame: 96 hours
measure: Oxygen saturation
timeFrame: 96 hours
measure: Pulmonary complications
timeFrame: 96 hours
measure: Ventilator
timeFrame: 96 hours
measure: Overall length of stay
timeFrame: 96 hours
measure: ICU stay
timeFrame: 96 hours
measure: Costs
timeFrame: 96 hours
measure: Overall complication rate
timeFrame: 96 hours
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Osf St Francis Medical Center
state: Illinois
Study officials:
affiliation: OSF Healthcare System
name: Chadrick R Evans, MD
role: PRINCIPAL_INVESTIGATOR
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