NCT00130104

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 11, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

October 5, 2007

Status Verified

August 1, 2005

First QC Date

August 11, 2005

Last Update Submit

October 3, 2007

Conditions

Keywords

digital blockregional anesthesiafinger repairFingersAnesthesia, Conduction

Outcome Measures

Primary Outcomes (1)

  • Success of the two types of digital blocks

    immediate

Secondary Outcomes (3)

  • Pain experienced with the digital block

    immediate

  • Repairing physician satisfaction with the procedure

    immediate

  • complications associated with digital block

    30 days

Study Arms (1)

MCB

EXPERIMENTAL

randomized to receive the metacarpal block for anesthesia

Procedure: Transthecal Metacarpal Block

Interventions

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital Of Philadelphia Emergency Department

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (16)

  • Bhende MS, Dandrea LA, Davis HW. Hand injuries in children presenting to a pediatric emergency department. Ann Emerg Med. 1993 Oct;22(10):1519-23. doi: 10.1016/s0196-0644(05)81251-x.

    PMID: 8214828BACKGROUND
  • 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.

    BACKGROUND
  • Robson AK, Bloom PA. Suturing of digital lacerations: digital block or local infiltration? Ann R Coll Surg Engl. 1990 Nov;72(6):360-1.

    PMID: 2241053BACKGROUND
  • Flarity-Reed K. Methods of digital block. J Emerg Nurs. 2002 Aug;28(4):351-4. doi: 10.1067/men.2002.125539. No abstract available.

    PMID: 12122413BACKGROUND
  • Chiu DT. Transthecal digital block: flexor tendon sheath used for anesthetic infusion. J Hand Surg Am. 1990 May;15(3):471-7. doi: 10.1016/0363-5023(90)90063-w.

    PMID: 2348068BACKGROUND
  • Brutus JP, Baeten Y, Chahidi N, Kinnen L, Ledoux P, Moermans JP. Single injection digital block: comparison between three techniques. Chir Main. 2002 May;21(3):182-7. doi: 10.1016/s1297-3203(02)00107-5.

    PMID: 12116830BACKGROUND
  • Cummings AJ, Tisol WB, Meyer LE. Modified transthecal digital block versus traditional digital block for anesthesia of the finger. J Hand Surg Am. 2004 Jan;29(1):44-8. doi: 10.1016/j.jhsa.2003.09.018.

    PMID: 14751102BACKGROUND
  • Low CK, Vartany A, Engstrom JW, Poncelet A, Diao E. Comparison of transthecal and subcutaneous single-injection digital block techniques. J Hand Surg Am. 1997 Sep;22(5):901-5. doi: 10.1016/S0363-5023(97)80088-3.

    PMID: 9330152BACKGROUND
  • Morrison WG. Transthecal digital block. Arch Emerg Med. 1993 Mar;10(1):35-8. doi: 10.1136/emj.10.1.35.

    PMID: 8452611BACKGROUND
  • Torok PJ, Flinn SD, Shin AY. Transthecal digital block at the proximal phalanx. J Hand Surg Br. 2001 Feb;26(1):69-71. doi: 10.1054/jhsb.2000.0519.

    PMID: 11162023BACKGROUND
  • Hill RG Jr, Patterson JW, Parker JC, Bauer J, Wright E, Heller MB. Comparison of transthecal digital block and traditional digital block for anesthesia of the finger. Ann Emerg Med. 1995 May;25(5):604-7. doi: 10.1016/s0196-0644(95)70171-0.

    PMID: 7741335BACKGROUND
  • Hollander JE, Valentine SM, Brogan GX Jr. Academic associate program: integrating clinical emergency medicine research with undergraduate education. Acad Emerg Med. 1997 Mar;4(3):225-30. doi: 10.1111/j.1553-2712.1997.tb03747.x.

    PMID: 9063553BACKGROUND
  • Castellanos J, Ramirez C, De Sena L, Bertran C. Transthecal digital block: digital anaesthesia through the sheath of the flexor tendon. J Bone Joint Surg Br. 2000 Aug;82(6):889. doi: 10.1302/0301-620x.82b6.10430.

    PMID: 10990318BACKGROUND
  • Lewis L, Stephan M. Local and Regional Anesthesia. In: Henretig F, King C, eds. Pediatric Emergency Procedures. Baltimore: Williams and Wilkins, 1997.

    BACKGROUND
  • Carlson D, et al. Illustrated Techniques of Pediatric Emergency Procedures. In: Fleisher G, Ludwig S, eds. Pediatric Emergency Medicine. Philadelphia: Williams and Wilkins, 2000.

    BACKGROUND
  • Antevy PM, Zuckerbraun NS, Saladino RA, Pitetti RD. Evaluation of a transthecal digital nerve block in the injured pediatric patient. Pediatr Emerg Care. 2010 Mar;26(3):177-80. doi: 10.1097/PEC.0b013e3181d1dfaf.

    PMID: 20179662BACKGROUND

MeSH Terms

Conditions

Finger Injuries

Condition Hierarchy (Ancestors)

Hand InjuriesWounds and Injuries

Study Officials

  • Elizabeth R Alpern, MD, MSCE

    The Children's Hospital of Philadelphia, Division of Emergency Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 11, 2005

First Posted

August 15, 2005

Study Start

July 1, 2005

Study Completion

August 1, 2007

Last Updated

October 5, 2007

Record last verified: 2005-08

Locations