Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00413582
Status:
COMPLETED
Last Update Posted:
2012-01-16
First Post:
2006-12-18
Brief Title:
Pain Management for Pectus Excavatum Repair
Sponsor:
Childrens Mercy Hospital Kansas City
Organization:
Childrens Mercy Hospital Kansas City
Study Overview
Official Title:
Prospective Randomized Trial Pain Management Strategy After Pectus Excavatum Repair
Status:
COMPLETED
Status Verified Date:
2011-12
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:
The objective of this study is to scientifically evaluate two different management strategies for post-operative pain after pectus excavatum repair
The hypothesis is that pain management without an epidural decreases hospital stay without compromising comfort
The primary outcome variable is length of hospitalization after the intervention
The hypothesis is that pain management without an epidural decreases hospital stay without compromising comfort
The primary outcome variable is length of hospitalization after the intervention
Detailed Description:
This will be a single institution prospective randomized clinical trial involving patients who undergo the minimally invasive repair of a pectus excavatum deformity with bar placement This is intended to be a definitive study
Power calculations based on the known length of hospitalization listed above with α 005 and power of 08 show the need for 55 patients in each arm The primary end point will be reached during the hospital stay therefore we expect a very small amount of attrition and will intend to recruit 110 One group will undergo an attempt for epidural regional analgesia epidural for post-operative pain control The other groups will receive patient controlled intravenous systemic analgesia PCA
Both groups will have the same management algorithm All data will be analyzed on intention-to-treat basis
Power calculations based on the known length of hospitalization listed above with α 005 and power of 08 show the need for 55 patients in each arm The primary end point will be reached during the hospital stay therefore we expect a very small amount of attrition and will intend to recruit 110 One group will undergo an attempt for epidural regional analgesia epidural for post-operative pain control The other groups will receive patient controlled intravenous systemic analgesia PCA
Both groups will have the same management algorithm All data will be analyzed on intention-to-treat basis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None