Ignite Creation Date:
2024-05-06 @ 3:51 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02390440
Status:
WITHDRAWN
Last Update Posted:
2017-01-19
First Post:
2015-03-03
Brief Title:
Exparel for Pain Control During Care of Rib Fractures
Sponsor:
Michael Moncure MD
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
Liposomal Bupivicaine Exparel for Pain Control During Care of Rib Fractures
Status:
WITHDRAWN
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Did not obtain an IND
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Rib fractures are common in patients who have suffered a traumatic injury occurring in about 10 of general injury cases and in about 30 of cases where the injury is directly to the chest Usually caused by injury to the chest wall rib fractures most often occur where the ribs bend and are most fragile These kinds of injuries are commonly caused by motor vehicle collisions falls assault industrial accidents gunshots or repetitive causes such as severe coughing or use-injury in athletes With any of these types of injury the first concern of the physician is to repair any immediate damage to the chest wall such as penetrating wounds air or blood in the chest cavity that compresses the lungs or fixing the broken ribs in place Once these injuries are repaired and stabilized the patients care consists of controlling their pain and helping them recover normal breathing ability
In patients who are not admitted to the hospital for care usually with only 1 or 2 ribs broken care is often pain control using over the counter medicines like Tylenol or Ibuprofen called NSAIDS or prescription medicines like hydrocodone Vicodin The main concern during follow-up of these patients is full recovery of pain-free breathing ability In patients who are admitted to the hospital for treatment pneumonia is the most common complication associated with multiple broken ribs Pneumonia occurs in anywhere from 15 to 30 of these patients For long-acting pain control to help them breathe more easily studies have shown that epidural analgesia pain relieving drugs delivered through a thin tube called a catheter into the fluid surrounding the spinal cord is preferable over opioids whether given in pill form or through an IV Additional studies have shown better results with epidural pain control compared to opioid or NSAID use However with all of these methods come risks and side effects
Using oral NSAIDs can result in stomach irritation kidney injury or can interfere with the bodys ability to form blood clots Acetaminophen Tylenol has been shown to be toxic to the liver at higher doses Opioid use can lower a persons breathing ability even while it reduces their pain which is not wanted in patients already at higher risk for pneumonia Epidural placement is a complex procedure risks infection at the site of catheter insertion can cause itching and risks injury to both the spinal cord and the membrane surrounding it the dura
In patients who are not admitted to the hospital for care usually with only 1 or 2 ribs broken care is often pain control using over the counter medicines like Tylenol or Ibuprofen called NSAIDS or prescription medicines like hydrocodone Vicodin The main concern during follow-up of these patients is full recovery of pain-free breathing ability In patients who are admitted to the hospital for treatment pneumonia is the most common complication associated with multiple broken ribs Pneumonia occurs in anywhere from 15 to 30 of these patients For long-acting pain control to help them breathe more easily studies have shown that epidural analgesia pain relieving drugs delivered through a thin tube called a catheter into the fluid surrounding the spinal cord is preferable over opioids whether given in pill form or through an IV Additional studies have shown better results with epidural pain control compared to opioid or NSAID use However with all of these methods come risks and side effects
Using oral NSAIDs can result in stomach irritation kidney injury or can interfere with the bodys ability to form blood clots Acetaminophen Tylenol has been shown to be toxic to the liver at higher doses Opioid use can lower a persons breathing ability even while it reduces their pain which is not wanted in patients already at higher risk for pneumonia Epidural placement is a complex procedure risks infection at the site of catheter insertion can cause itching and risks injury to both the spinal cord and the membrane surrounding it the dura
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None