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

Phase 4

• Conditions: Trauma; Trauma Injury; Pain, Acute
• Interventions: Drug: Bupivacaine Liposome Injection; Drug: Bupivacaine

• Registration Number: NCT03574376
• Lead Sponsor: Chadrick Evans

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

Study Timeline

• Study First Submitted: 2018-06-01
• Study First Submitted QC: 2018-06-19
• Study First Posted: 2018-07-02
• Study Start: 2018-08-29
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-05
• Last Update Posted: 2020-03-09
• Primary Completion: 2020-08-01
• Study Completion: 2021-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 258

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine Liposome Injection [Exparel]	Bupivacaine Liposome Injection	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.
Epidural 0.125% bupivicaine	Bupivacaine	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.

Primary Outcome Measures

Name	Time	Method
Change in pain relief	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Osf St Francis Medical Center; 🇺🇸 Peoria, Illinois, United States