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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00130104
Other study ID # 2005-5-4319
Secondary ID
Status Completed
Phase Phase 4
First received August 11, 2005
Last updated October 3, 2007
Start date July 2005
Est. completion date August 2007

Study information

Verified date August 2005
Source Children's Hospital of Philadelphia
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date August 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Transthecal Metacarpal Block


Locations

Country Name City State
United States The Children's Hospital Of Philadelphia Emergency Department Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Children's Hospital of Philadelphia University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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

Castellanos J, Ramírez C, De Sena L, Bertrán C. Transthecal digital block: digital anaesthesia through the sheath of the flexor tendon. J Bone Joint Surg Br. 2000 Aug;82(6):889. — View Citation

Chiu DT. Transthecal digital block: flexor tendon sheath used for anesthetic infusion. J Hand Surg Am. 1990 May;15(3):471-7. — View Citation

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. — View Citation

Flarity-Reed K. Methods of digital block. J Emerg Nurs. 2002 Aug;28(4):351-4. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

Morrison WG. Transthecal digital block. Arch Emerg Med. 1993 Mar;10(1):35-8. — View Citation

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

Torok PJ, Flinn SD, Shin AY. Transthecal digital block at the proximal phalanx. J Hand Surg Br. 2001 Feb;26(1):69-71. — View Citation

* Note: There are 16 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Success of the two types of digital blocks immediate
Secondary Pain experienced with the digital block immediate
Secondary Repairing physician satisfaction with the procedure immediate
Secondary complications associated with digital block 30 days
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