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

Sponsor

Chadrick Evans (Other)

Overall Status

Unknown status

CT.gov ID

NCT03574376

Collaborator

University of Illinois College of Medicine at Peoria (Other), OSF Healthcare System (Other)

258

Enrollment

Location

Arms

35.1

Anticipated Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Trauma Trauma Injury Pain, Acute	Drug: Bupivacaine Liposome Injection Drug: Bupivacaine	Phase 4

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.

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 Design

Study Type:

Interventional

Anticipated Enrollment :

258 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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)

Masking Description:

No participants are blinded to treatment arms. Patients and investigators are aware of which patients are assigned to each treatment group.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 29, 2018

Anticipated Primary Completion Date :

Aug 1, 2020

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Bupivacaine Liposome Injection 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 Other Names: Exparel
Active Comparator: 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.	Drug: Bupivacaine 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 Other Names: bupivacaine Hcl

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Bupivacaine Liposome Injection

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

Other Names:

Exparel

Active Comparator: 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.

Drug: Bupivacaine

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

Other Names:

bupivacaine Hcl

Outcome Measures

Primary Outcome Measures

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

Quantity of pain medication [96 hours]
Amount of breakthrough analgesia required in morphine equivalents
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
Supplemental oxygen [96 hours]
Supplemental oxygen requirements
Oxygen saturation [96 hours]
Oxygen saturation levels
Pulmonary complications [96 hours]
Development of pulmonary complications: atelectasis, pneumonia, respiratory failure
Ventilator [96 hours]
Ventilator days
Overall length of stay [96 hours]
Length of stay
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 >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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Osf St Francis Medical Center	Peoria	Illinois	United States	61604

Sponsors and Collaborators

Chadrick Evans
University of Illinois College of Medicine at Peoria
OSF Healthcare System

Investigators

Principal Investigator: Chadrick R Evans, MD, OSF Healthcare System

Study Documents (Full-Text)

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Chadrick Evans, Director of Surgical ICU and Trauma, OSF Healthcare System

ClinicalTrials.gov Identifier:

NCT03574376

Other Study ID Numbers:

1146837-2

First Posted:

Jul 2, 2018

Last Update Posted:

Mar 9, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Chadrick Evans, Director of Surgical ICU and Trauma, OSF Healthcare System

Rib trauma, intercostal nerve block, liposomal bupivacaine

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2020