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Finger InjuriesPhase 4NCT00130104

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

A Phase 4 study testing Transthecal Metacarpal Block in people with Finger Injuries, run by Children's Hospital of Philadelphia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Finger Injuries
What is being tested?
Transthecal Metacarpal Block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteUnited States
Study dates
Jul 2005to Aug 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Children's Hospital Of Philadelphia Emergency Department

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Transthecal Metacarpal Block vs Traditional Digital Block for Painful Finger Procedures in Children

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.

Read the 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.

Conditions
Finger Injuries
Being tested
Transthecal Metacarpal Block
Keywords
digital block, regional anesthesia, finger repair, Fingers, Anesthesia, Conduction
Medical subject headings
Finger Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transthecal Metacarpal BlockProcedure or surgery

Study groups in NCT00130104
Study groupRoleWhat they receive
MCBExperimentalrandomized to receive the metacarpal block for anesthesia
Receives: Procedure: Transthecal Metacarpal Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Success of the two types of digital blocks

    Measured: immediate

Secondary outcomes (3)

  1. Pain experienced with the digital block

    Measured: immediate

  2. Repairing physician satisfaction with the procedure

    Measured: immediate

  3. complications associated with digital block

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2005 (estimated)
  2. Study startJul 2005
  3. Study completionAug 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00130104
Sponsor's protocol ID
2005-5-4319
Status last verified
Aug 2005
First submitted
11 Aug 2005
Last updated
5 Oct 2007
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 8214828

  • 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.

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

    PubMed 2241053

  • 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.

    PubMed 12122413

  • 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.

    PubMed 2348068

  • 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.

    PubMed 12116830

  • 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.

    PubMed 14751102

  • 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.

    PubMed 9330152

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

    PubMed 8452611

  • 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.

    PubMed 11162023

  • 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.

    PubMed 7741335

  • 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.

    PubMed 9063553

  • 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.

    PubMed 10990318

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Transthecal Metacarpal Block in people with Finger Injuries, run by Children's Hospital of Philadelphia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success of the two types of digital blocks (time frame: immediate). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00130104, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2007.

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