Exparel for Pain Control During Care of Rib Fractures

NCT02390440 | Withdrawn Phase 4

• 1 other identifier: CRA_IIT_Exparel_RibFractures
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is looking at a novel therapy of numbing medication injected directly around the fracture site. The purpose of this study is to determine if the study medication, EXPAREL®, is a viable alternative to current therapies for rib fractures.

Conditions

Pain

Keywords

Pain management; Exparel; Rib fracture

Outcome Measures

Primary Outcomes (1)

• Pain relief (visual analog scale)

  pain relief as measured by visual analog scale and patient satisfaction survey, before and after drug administration

  Change from Treatment to Hour 72

Secondary Outcomes (3)

• Length of hospital stay post treatment

  Up to 10 days, average length of stay expected to be 3 days

• opioid use

  Change from Treatment to Hour 72

• change in lung function as evidenced by use of incentive spirometry

  Change from Treatment to Hour 72

Study Arms (1)

EXPAREL

EXPERIMENTAL

single dose, 266mg (20mL) of EXPAREL injected to slowly infiltrate the soft tissue around the site of fracture

Drug: EXPAREL

Interventions

EXPAREL DRUG

Also known as: Liposomal Bupivicaine

EXPAREL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients 18 years of age or older
• patients with three or more rib fractures occurring either unilaterally or bilaterally
• patients who are awake enough to assess pain severity

You may not qualify if:

• patients whose pain in other anatomical areas limit rib fracture pain assessment
• patients with a history of hypersensitivity or idiosyncratic reactions or intolerance to any local anesthetic, opioids, or ketorolac
• patients who abuse alcohol or other drug substances
• patients on chronic opioid therapy (taken an opioid 5 of the last 7 days)
• pregnant patients
• severe hepatic impairment
• persistent pain patients requiring 20mg oral morphine equivalent or greater in the 24 hour period prior to sustaining multiple rib fractures
• allergies to common agents used in Exparel (bupivacaine, liposome)
• inability to provide informed consent

Sponsors & Collaborators

• Michael Moncure, MD: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Pain; Agnosia; Rib Fractures

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Study Officials

• Michael Moncure, MD, FACS

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 3, 2015
• First Posted: March 17, 2015
• Study Start: April 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 19, 2017

Record last verified: 2017-01

Locations

US (1)