Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2026-01-05 @ 5:43 PM
Study NCT ID:
NCT06465992
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-20
First Post:
2024-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liposomal Bupivacaine With Dexamethasone for Foot Surgery
Sponsor:
Rothman Institute Orthopaedics
Organization:
Study Overview
Official Title:
Single-Shot Liposomal Bupivacaine vs. Liposomal Bupivacaine Combined With Dexamethasone Prior to Foot and Ankle Procedures: A Prospective Randomized Controlled Trial
Status:
ENROLLING_BY_INVITATION
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:
This study aims to understand the ideal formulation to utilize in saphenous nerve and popliteal nerve blocks for foot and ankle procedures. It will examine the use of liposomal bupivacaine alone or liposomal bupivacaine with dexamethasone prior to foot and ankle procedures in peripheral nerve blocks. We will compare liposomal bupivacaine (Exparel) and liposomal bupivacaine (Exparel) combined with dexamethasone to determine if the addition of dexamethasone significantly decreases postoperative narcotic use and prolongs analgesic effects when administered in a popliteal and saphenous block prior to foot and ankle orthopedic procedures.
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?: