Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130104
Status:
COMPLETED
Last Update Posted:
2007-10-05
First Post:
2005-08-11
Brief Title:
Transthecal Metacarpal Block Versus Traditional Digital Block for Painful Finger Procedures in Children
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
Transthecal Metacarpal Block vs Traditional Digital Block for Painful Finger Procedures in Children
Status:
COMPLETED
Status Verified Date:
2005-08
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 purpose of this study is to determine if the transthecal metacarpal block is superior to the traditional digital block for regional digital anesthesia in children
Detailed Description:
Background Finger injuries and infections are common presenting problems in the pediatric emergency department A traditional digital block requiring at least two injections of anesthetic is the traditional method of regional anesthesia for many finger procedures Digital blocks can sometimes be difficult to administer and assess for effectiveness especially in children A newer procedure the transthecal metacarpal block may be easier to administer and more effective with one injection
Objective To determine if the transthecal metacarpal block MCB provides superior digit anesthesia in children requiring painful finger procedures as compared to the traditional digital block TDB
Methods A randomized clinical trial comparing the MCB to the TDB will be conducted in an urban tertiary care pediatric emergency department Children 18 years of age presenting to the emergency department with a finger injury or infection which requires regional anesthesia for repair will be screened for eligibility Eligible patients with appropriate consent will be randomized to receive either the MCB or TDB with 1 Lidocaine The primary outcome success of the block will be assessed using pinprick testing after a standardized wait time Secondary outcomes including pain with the block and repair repairing physician satisfaction and short-term complications will also be assessed
Implications Finding successful methods of anesthesia and pain control are paramount in the pediatric emergency department In addition using a type of digital block which is easy to administer successful and requires only one injection would give physicians confidence to treat finger injuries in children with regional anesthesia and possibly avoid procedural sedation in some cases To date no studies have been published on the efficacy of digital blocks in children This study will also serve to give baseline success rates for both types of digital blocks
Objective To determine if the transthecal metacarpal block MCB provides superior digit anesthesia in children requiring painful finger procedures as compared to the traditional digital block TDB
Methods A randomized clinical trial comparing the MCB to the TDB will be conducted in an urban tertiary care pediatric emergency department Children 18 years of age presenting to the emergency department with a finger injury or infection which requires regional anesthesia for repair will be screened for eligibility Eligible patients with appropriate consent will be randomized to receive either the MCB or TDB with 1 Lidocaine The primary outcome success of the block will be assessed using pinprick testing after a standardized wait time Secondary outcomes including pain with the block and repair repairing physician satisfaction and short-term complications will also be assessed
Implications Finding successful methods of anesthesia and pain control are paramount in the pediatric emergency department In addition using a type of digital block which is easy to administer successful and requires only one injection would give physicians confidence to treat finger injuries in children with regional anesthesia and possibly avoid procedural sedation in some cases To date no studies have been published on the efficacy of digital blocks in children This study will also serve to give baseline success rates for both types of digital blocks
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