Recruiting

Liposomal Bupivacaine vs. Thoracic Epidural

Sponsor:

Chadrick Evans

Code:

NCT03574376

Conditions

Trauma

Trauma Injury

Pain, Acute

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bupivacaine Liposome Injection

Bupivacaine

Study Details

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

Conditions

Trauma

Trauma Injury

Pain, Acute

Study ID

NCT03574376

Start date

Aug 29, 2018

Status verified date

Mar, 2020

Completion date

Aug 1, 2021

Anticipated

Primary completion date

Aug 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

258 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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

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

Primary outcome measure

  • Change in pain relief [ Time Frame: 96 hours ]

Central Contacts and Locations

Central contacts

Locations

Osf St Francis Medical Center

Recruiting

Peoria, Illinois, United States, 61604

Contacts

More Information

Sponsor

Chadrick Evans

Last update posted

Mar 9, 2020

Last verified

Mar, 2020

Keywords

  • Rib trauma, intercostal nerve block, liposomal bupivacaine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Chadrick Evans on 2020-03-09.