Ignite Creation Date:
2024-07-17 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471348
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-05-21
Brief Title:
Postoperative Pain Control in AIS Using Liposomal Bupivacaine vs 025 Bupivacaine With Epinephrine
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
Postoperative Pain Control in AIS Using Liposomal Bupivacaine vs 025 Bupivacaine
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
A randomized controlled trial RCT investigating whether the local anesthetic injection of liposomal bupivacaine during posterior spinal fusion PSF for AIS is more effective in reducing acute postoperative opioid consumption compared to an equal volume injection of 025 bupivacaine with epinephrine for patients aged 10 to 17 with 128 patients randomly assigned to one of two arms liposomal bupivacaine or 025 bupivacaine with epinephrine
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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