Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04751344
Status:
UNKNOWN
Last Update Posted:
2021-02-25
First Post:
2021-02-05
Brief Title:
Liposomal Bupivacaine Versus Bupivacaine Plain for Operative Pain Management of Forefoot Surgery
Sponsor:
Alexandra Black
Organization:
Lenox Hill Hospital
Study Overview
Official Title:
RANDOMIZED CONTROLLED TRIAL COMPARING LIPOSOMAL BUPIVACAINE VERSUS BUPIVACAINE HCL FOR POSTOPERATIVE MANAGEMENT OF FOREFOOT SURGERY
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
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:
Prospective randomized controlled single-blinded trial comparing liposomal bupivacaine with bupivacaine HCl for postoperative management Upon completion of the forefoot procedure in the operative room the subject will be entered into the randomization system which will specify whether to inject 10cc 5mgmL of bupivacaine HCl or 8cc 133 mgmL liposomal bupivacaine both considered routine care procedure Thereafter postoperative pain will be assessed and measured using a Visual Analog Scale VAS scoring scale post-operatively at 2 hours 24 hours 48 hours and 72 hours In addition the amount of oral morphine equivalents OME required postoperatively and time to first use of OME will be measured Our hypothesis is that patients who received liposomal bupivacaine will have less post-operative pain and require less OMEs
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?:
None