Ignite Creation Date:
2024-05-06 @ 1:29 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01826851
Status:
COMPLETED
Last Update Posted:
2018-08-01
First Post:
2013-03-25
Brief Title:
Parasternal Nerve Block in Cardiac Patients
Sponsor:
Peter A Knight
Organization:
University of Rochester
Study Overview
Official Title:
Parasternal Intercostal Nerve Block in Post-Cardiac Surgery Patients A Randomized Controlled Trial of Extended-release Liposomal Bupivacaine Exparel Versus Placebo
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Exparel is a new local analgesic numbing medication that is intended to be longer acting than currently available local analgesics The purpose of this study is to determine whether use of Exparel to numb the nerves along the breastbone after open heart surgery will decrease pain and pain medication use after surgery
Detailed Description:
This is a Phase 2 single-institution randomized double-blind parallel-group placebo-controlled trial of patients undergoing a median sternotomy for primary cardiopulmonary bypass grafting CABG surgery
78 subjects 39 per treatment arm will be randomized in a 11 ratio to receive a single-dose parasternal nerve block with either 266 mg Exparel or placebo 09 normal saline solution The nerve blocks will be performed under direct visualization at the end of surgery just prior to sternal closure
78 subjects 39 per treatment arm will be randomized in a 11 ratio to receive a single-dose parasternal nerve block with either 266 mg Exparel or placebo 09 normal saline solution The nerve blocks will be performed under direct visualization at the end of surgery just prior to sternal closure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None