Ignite Creation Date:
2024-05-06 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 12:46 PM
Study NCT ID:
NCT03538340
Status:
UNKNOWN
Last Update Posted:
2021-04-27
First Post:
2018-03-07
Brief Title:
Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Randomized Single-Blinded Controlled Trial Using Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy ICE Study
Status:
UNKNOWN
Status Verified Date:
2021-04
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:
ICE
Brief Summary:
The ICE Study study will compare standard therapy thoracic epidural versus a novel approach Cryoanalgesia combined with thoracic epidural in subjects undergoing unilateral thoracotomy
Detailed Description:
The ICE Study is a single institution pilot study designed to compare standard therapy ie thoracic epidural versus a novel approach ie Cryoanalgesia combined with thoracic epidural to address the need for better management of acute and long-term pain in the general thoracic surgery patient population The studys primary objective will be to demonstrate if the new intraoperative pain management approach ie intercostal Cryoanalgesia in conjunction with thoracic epidural provides superior short-term and long-term analgesia efficacy in patients undergoing unilateral thoracotomy as compared to the current institutional standard of care ie thoracic epidural Patients will be randomized in a 11 design
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None