Transthecal Metacarpal Block Versus Traditional Digital Block for Painful Finger Procedures in Children
Primary Purpose
Finger Injuries
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Transthecal Metacarpal Block
Sponsored by
About this trial
This is an interventional treatment trial for Finger Injuries focused on measuring digital block, regional anesthesia, finger repair, Fingers, Anesthesia, Conduction
Eligibility Criteria
Inclusion Criteria: Age <18 years Greater than 10 kg in weight Have finger injuries or infections that will require digital regional anesthesia Require only local anesthesia for the repair English speaking Exclusion Criteria: Have previous participation in this study Need procedural sedation at the onset of the repair Have allergy to lidocaine or amide-type local anesthetics Have infection at the sites of block injection Have known coagulopathy
Sites / Locations
- The Children's Hospital Of Philadelphia Emergency Department
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MCB
Arm Description
randomized to receive the metacarpal block for anesthesia
Outcomes
Primary Outcome Measures
Success of the two types of digital blocks
Secondary Outcome Measures
Pain experienced with the digital block
Repairing physician satisfaction with the procedure
complications associated with digital block
Full Information
NCT ID
NCT00130104
First Posted
August 11, 2005
Last Updated
October 3, 2007
Sponsor
Children's Hospital of Philadelphia
Collaborators
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT00130104
Brief Title
Transthecal Metacarpal Block Versus Traditional Digital Block for Painful Finger Procedures in Children
Official Title
Transthecal Metacarpal Block vs Traditional Digital Block for Painful Finger Procedures in Children
Study Type
Interventional
2. Study Status
Record Verification Date
August 2005
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
University of Pennsylvania
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Finger Injuries
Keywords
digital block, regional anesthesia, finger repair, Fingers, Anesthesia, Conduction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MCB
Arm Type
Experimental
Arm Description
randomized to receive the metacarpal block for anesthesia
Intervention Type
Procedure
Intervention Name(s)
Transthecal Metacarpal Block
Primary Outcome Measure Information:
Title
Success of the two types of digital blocks
Time Frame
immediate
Secondary Outcome Measure Information:
Title
Pain experienced with the digital block
Time Frame
immediate
Title
Repairing physician satisfaction with the procedure
Time Frame
immediate
Title
complications associated with digital block
Time Frame
30 days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age <18 years
Greater than 10 kg in weight
Have finger injuries or infections that will require digital regional anesthesia
Require only local anesthesia for the repair
English speaking
Exclusion Criteria:
Have previous participation in this study
Need procedural sedation at the onset of the repair
Have allergy to lidocaine or amide-type local anesthetics
Have infection at the sites of block injection
Have known coagulopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth R Alpern, MD, MSCE
Organizational Affiliation
The Children's Hospital of Philadelphia, Division of Emergency Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital Of Philadelphia Emergency Department
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
8214828
Citation
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PubMed Identifier
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Transthecal Metacarpal Block Versus Traditional Digital Block for Painful Finger Procedures in Children
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