Transthecal Metacarpal Block Versus Traditional Digital Block for Painful Finger Procedures in Children

This study has been completed.
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00130104
First received: August 11, 2005
Last updated: October 3, 2007
Last verified: August 2005
  Purpose

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.


Condition Intervention Phase
Finger Injuries
Procedure: Transthecal Metacarpal Block
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transthecal Metacarpal Block vs Traditional Digital Block for Painful Finger Procedures in Children

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Success of the two types of digital blocks [ Time Frame: immediate ]

Secondary Outcome Measures:
  • Pain experienced with the digital block [ Time Frame: immediate ]
  • Repairing physician satisfaction with the procedure [ Time Frame: immediate ]
  • complications associated with digital block [ Time Frame: 30 days ]

Enrollment: 92
Study Start Date: July 2005
Study Completion Date: August 2007
Arms Assigned Interventions
Experimental: MCB
randomized to receive the metacarpal block for anesthesia
Procedure: Transthecal Metacarpal Block

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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130104

Locations
United States, Pennsylvania
The Children's Hospital Of Philadelphia Emergency Department
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
University of Pennsylvania
Investigators
Principal Investigator: Elizabeth R Alpern, MD, MSCE The Children's Hospital of Philadelphia, Division of Emergency Medicine
  More Information

Publications:
Kelly JJ, Spektor M. Nerve Blocks of the Thorax and Extremities. In:Roberts J, Hedges J, eds. Clinical Procedures in Emergency Medicine. St. Louis: WB Saunders, 2004.
Lewis L, Stephan M. Local and Regional Anesthesia. In: Henretig F, King C, eds. Pediatric Emergency Procedures. Baltimore: Williams and Wilkins, 1997.
Carlson D, et al. Illustrated Techniques of Pediatric Emergency Procedures. In: Fleisher G, Ludwig S, eds. Pediatric Emergency Medicine. Philadelphia: Williams and Wilkins, 2000.
Antevy PM, Zuckerbraun N, Pitetti R. Evaluation of a Transthecal Digital Nerve Block in the Injured Pediatric Patient. PAS 2005; 57:2907. Washington, DC.

ClinicalTrials.gov Identifier: NCT00130104     History of Changes
Other Study ID Numbers: 2005-5-4319
Study First Received: August 11, 2005
Last Updated: October 3, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
digital block
regional anesthesia
finger repair
Fingers
Anesthesia, Conduction

Additional relevant MeSH terms:
Finger Injuries
Hand Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014