Ignite Creation Date:
2024-05-06 @ 1:36 AM
Last Modification Date:
2024-10-26 @ 11:06 AM
Study NCT ID:
NCT01853176
Status:
TERMINATED
Last Update Posted:
2014-11-02
First Post:
2013-05-10
Brief Title:
Exparel vs Standard Bupivicaine for Abdominoplasty
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Is Liposomal Injection Bupivacaine Exparel Superior to Standard Bupivacaine for Abdominoplasty A Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
required documentation too onerous
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background study question
Strategies for post-operative pain control that make use of various different types of medicines are advantageous both for patient comfort and for minimizing the use of opioid pain medicines and their associated side effects which include drowsiness nausea and vomiting A key element of these strategies is wound injection with local anesthetic numbing medicine at the time of surgery Local numbing procedures are used routinely in patients undergoing abdominoplasty tummy tuck most often with lidocaine or bupivacaine which can last several hours Multiple studies have shown that locally injected pain medicines achieve better pain control less opioid use and faster return to normal activities such that the use of one of these local anesthetic medicines is the current standard of care
Exparel is an extended-release formulation of bupivacaine that can produce local pain relief for up to 72 hours Studies have shown it to provide better post-operative pain control and decreased use of opioid medications when compared to patients who did not receive any local numbing agents Exparel has been used successfully in a variety of surgical settings including open colon surgery laparoscopic gall bladder removal abdominoplasty and breast augmentation Its effectiveness has by and large been established in comparison to no local anesthetic In this study we seek to investigate the benefit of Exparel compared to standard bupivacaine infiltration in patients undergoing abdominoplasty
Study design
Patients scheduled for abdominoplasty with the lead investigator will be offered inclusion in this study Consenting patients will be randomly assigned to standard bupivacaine or Exparel by coin toss after their clinic visit On the day of surgery the only difference between patients assigned to one arm or the other is the local anesthetic used The surgery itself and plan for general anesthesia will be similar Both groups will have the same pain medicines available after surgery
Patients will be given a form on which to record twice-daily pain ratings and opioid narcotic needs for 3 days after surgery For patients admitted after surgery oral and IV narcotic use will be collected from their inpatient medical record
The primary outcome of interest is daily and cumulative pain scores through 3 days A secondary endpoint is daily and total opioid use over 3 days Additional measures include the time to first post-operative use of opioid medication and incidence of any adverse side effects
Strategies for post-operative pain control that make use of various different types of medicines are advantageous both for patient comfort and for minimizing the use of opioid pain medicines and their associated side effects which include drowsiness nausea and vomiting A key element of these strategies is wound injection with local anesthetic numbing medicine at the time of surgery Local numbing procedures are used routinely in patients undergoing abdominoplasty tummy tuck most often with lidocaine or bupivacaine which can last several hours Multiple studies have shown that locally injected pain medicines achieve better pain control less opioid use and faster return to normal activities such that the use of one of these local anesthetic medicines is the current standard of care
Exparel is an extended-release formulation of bupivacaine that can produce local pain relief for up to 72 hours Studies have shown it to provide better post-operative pain control and decreased use of opioid medications when compared to patients who did not receive any local numbing agents Exparel has been used successfully in a variety of surgical settings including open colon surgery laparoscopic gall bladder removal abdominoplasty and breast augmentation Its effectiveness has by and large been established in comparison to no local anesthetic In this study we seek to investigate the benefit of Exparel compared to standard bupivacaine infiltration in patients undergoing abdominoplasty
Study design
Patients scheduled for abdominoplasty with the lead investigator will be offered inclusion in this study Consenting patients will be randomly assigned to standard bupivacaine or Exparel by coin toss after their clinic visit On the day of surgery the only difference between patients assigned to one arm or the other is the local anesthetic used The surgery itself and plan for general anesthesia will be similar Both groups will have the same pain medicines available after surgery
Patients will be given a form on which to record twice-daily pain ratings and opioid narcotic needs for 3 days after surgery For patients admitted after surgery oral and IV narcotic use will be collected from their inpatient medical record
The primary outcome of interest is daily and cumulative pain scores through 3 days A secondary endpoint is daily and total opioid use over 3 days Additional measures include the time to first post-operative use of opioid medication and incidence of any adverse side effects
Detailed Description:
None
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