Trial of Injected Liposomal Bupivacaine vs Bupivacaine Infusion After Surgical Stabilization of Rib Fractures

Summary

Rib fractures represent a common injury pattern this is highly associated with patient morbidity and mortality, as pain control remains a challenge. Even after surgical stabilization of rib fractures (SSRF), unsuccessful pain control can lead to morbid outcomes such as pneumonia and opioid dependence. Multi-modal anesthesia, with the use of thoracic epidurals and para-vertebral injections/catheters, has shown to lessen these occurrences but are subject to a wide array of limitations. A more directed therapy with liposomal bupivacaine has shown to provide sustained analgesia for up to 72 hours in patients who have undergone other types of thoracic surgery, but not SSRF. The hypothesis of the current clinical trial is that, among patients undergoing SSRF, liposomal bupivacaine delivered via video assisted thoracic surgery (VATS) is an intercostal nerve block that provides comparable analgesia to the pain catheter, as measured by pulmonary function, numeric pain scoring, and postoperative narcotic use.

Conditions

• Drug Effect
• Rib Fractures
• Rib Trauma
• Surgical Procedure, Unspecified
• Pain; Catheter (Other)
• Nerve Pain
• Local Infiltration
• Anesthesia, Local
• Intercostal Rib
• Opioid Dependence
• Chest Injury Trauma
• Pneumonia

Interventions

DRUG

Liposomal bupivacaine injection

A single injection of liposomal bupivacaine is administered at the time of SSRF, directly to the fracture site via VATS

DRUG

Bupivacaine indwelling catheter

Bupivacaine indwelling OnQ pain pump catheter is placed in the subscapular space at the time of SSRF for continuous bupivacaine infusion post op

Sponsors & Collaborators

• Denver Health and Hospital Authority

  lead OTHER

Principal Investigators

• Fredric Pieracci, MD MPH · Denver Health and Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-05

Primary Completion

2020-07-20

Completion

2021-01-31

FDA Drug

Yes

Countries

• United States

Study Locations