Traditional Dorsal Digital Block Vs Volar Subcutaneous Digital Block

NCT05280704 | Terminated

• 1 other identifier: 274026
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized, double-blinded controlled trial comparing two different techniques for digital blocks. Participants will be physicians who perform digital blocks as part of their everyday duty. Each participant will undergo two digital blocks and will have the opportunity to perform a digital block on another participant. This study follows a two-period cross-over design with four groups that are defined by the sequence of treatments within each group. Participants will receive two digital blocks, one using the traditional dorsal technique and one using the volar technique. Of the two injections, one of the syringes will contain 1% lidocaine without epinephrine and the other will contain sterile normal saline. The injections will be to the index finger on each hand. The hand injected first will be up to the participant. The order in which the dorsal technique versus the volar technique is performed will be randomized. Participants will not be told one of the syringes contains normal saline. Injection pain will be measured by visual analog score and recorded after each injection. Sensation in each of the 12 zones of the finger will be recorded at each minute mark until loss of sensation in all 12 zones is achieved or 15 minutes has passed, whichever comes first.

Conditions

Hand Injuries

Keywords

digital block

Outcome Measures

Primary Outcomes (1)

• Injection Pain

  The primary outcome is injection pain as measured by the visual analog score (VAS). The VAS for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient indicates a point on the line that matches the amount of pain he or she feels. Data for this outcome will be analyzed using mixed-models ANOVA with Subject as the random effect. The fixed effects in the ANOVA model will be the Technique main effect, the Agent main effect, the Technique-x-Agent interaction, and the Order main effect. Because each subject's two treatments will be administered to opposite hands, there should be no carryover effects, and the ANOVA model accordingly will not include Order interactions with Technique or Agent.

  Immediately upon injection

Secondary Outcomes (1)

• Efficacy of Desensitization

  Pinprick sensation will be tested in all 12 zones of the finger and recorded by the recorder at each minute mark up to 15 minutes or loss of sensation in all 12 zones, whichever comes first.

Study Arms (4)

V1 Lidocaine, D2 Saline

OTHER

Will undergo volar technique 1st with 4 mL of 1% lidocaine and then dorsal technique 2nd with 4 mL of 0.9% sterile saline. This is a 1-time dose.

Procedure: Volar digital block with lidocaine; Procedure: Dorsal digital block with saline

V1 Saline, D2 Lidocaine

OTHER

Will undergo volar technique 1st with 4 mL of 0.9% sterile saline and then dorsal technique 2nd with 4 mL of 1% lidocaine. This is a 1-time dose.

Procedure: Volar digital block with saline; Procedure: Dorsal digital block with lidocaine

D1 Lidocaine, V2 Saline

OTHER

Will undergo dorsal technique first with 4 mL of 1% lidocaine and then volar technique second with 0.9% sterile saline. This is a 1-time dose.

Procedure: Volar digital block with saline; Procedure: Dorsal digital block with lidocaine

D1 Saline, V2 Lidocaine

OTHER

Will undergo dorsal technique 1st with 4 mL of 0.9% sterile saline and then volar technique 2nd with 4 mL of 1% lidocaine. This is a 1-time dose.

Procedure: Volar digital block with lidocaine; Procedure: Dorsal digital block with saline

Interventions

Volar digital block with lidocaine PROCEDURE

Volar digital block with lidocaine

D1 Saline, V2 Lidocaine; V1 Lidocaine, D2 Saline

Volar digital block with saline PROCEDURE

Volar digital block with saline

D1 Lidocaine, V2 Saline; V1 Saline, D2 Lidocaine

Dorsal digital block with lidocaine PROCEDURE

Dorsal digital block with lidocaine

D1 Lidocaine, V2 Saline; V1 Saline, D2 Lidocaine

Dorsal digital block with saline PROCEDURE

Dorsal digital block with saline

D1 Saline, V2 Lidocaine; V1 Lidocaine, D2 Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physicians over the age of 18 who regularly perform digital blocks as part of their duty, including those who specialize in Orthopaedic Surgery, Pediatrics, Family Medicine and Emergency Medicine.

You may not qualify if:

• Participants with absence of an index finger on either side
• Pregnancy
• Neuropathy
• Hematologic disease
• Peripheral vascular disease
• Participants with a history of adverse reactions to lidocaine

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (12)

• Ito N, Umazume M, Ojima Y, Shibata D, Ida Y, Komiya T, Matsumura H. Comparison of traditional two-injection dorsal digital block versus transthecal and subcutaneous single-injection digital block: A systematic review and meta-analysis. Hand Surg Rehabil. 2021 Sep;40(4):369-376. doi: 10.1016/j.hansur.2021.04.004. Epub 2021 Apr 23.

  PMID: 33895422 BACKGROUND

• Whetzel TP, Mabourakh S, Barkhordar R. Modified transthecal digital block. J Hand Surg Am. 1997 Mar;22(2):361-3. doi: 10.1016/S0363-5023(97)80179-7. No abstract available.

  PMID: 9195442 BACKGROUND

• 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: 14751102 BACKGROUND

• Braun H, Harris ML. Operations on the extremities. In: Local Anesthesia: It's Scientific Basis and Practical Use. 2nd ed. Lea & Febiger; 1924:366-367.

  BACKGROUND

• Williams JG, Lalonde DH. Randomized comparison of the single-injection volar subcutaneous block and the two-injection dorsal block for digital anesthesia. Plast Reconstr Surg. 2006 Oct;118(5):1195-1200. doi: 10.1097/01.prs.0000237016.00941.96.

  PMID: 17016190 BACKGROUND

• Harbison S. "Transthecal digital block: flexor tendon sheath used for anaesthetic infusion". J Hand Surg Am. 1991 Sep;16(5):957. doi: 10.1016/s0363-5023(10)80172-8. No abstract available.

  PMID: 1940182 BACKGROUND

• Yin ZG, Zhang JB, Kan SL, Wang P. A comparison of traditional digital blocks and single subcutaneous palmar injection blocks at the base of the finger and a meta-analysis of the digital block trials. J Hand Surg Br. 2006 Oct;31(5):547-55. doi: 10.1016/j.jhsb.2006.06.001. Epub 2006 Aug 22.

  PMID: 16930788 BACKGROUND

• Bashir MM, Khan FA, Afzal S, Khan BA. Comparison of traditional two injections dorsal digital block with volar block. J Coll Physicians Surg Pak. 2008 Dec;18(12):768-70.

  PMID: 19032891 BACKGROUND

• Martin SP, Chu KH, Mahmoud I, Greenslade JH, Brown AF. Double-dorsal versus single-volar digital subcutaneous anaesthetic injection for finger injuries in the emergency department: A randomised controlled trial. Emerg Med Australas. 2016 Apr;28(2):193-8. doi: 10.1111/1742-6723.12559. Epub 2016 Mar 16.

  PMID: 26991958 BACKGROUND

• Afridi RA, Masood T, Ahmed E, Obaidullah AM, Alvi HF. Comparison of the efficacy of single volar subcutaneous digital block and the dorsal two injections block. J Ayub Med Coll Abbottabad. 2014 Jan-Mar;26(1):88-91.

  PMID: 25358227 BACKGROUND

• Okur OM, Sener A, Kavakli HS, Celik GK, Dogan NO, Icme F, Gunaydin GP. Two injection digital block versus single subcutaneous palmar injection block for finger lacerations. Eur J Trauma Emerg Surg. 2017 Dec;43(6):863-868. doi: 10.1007/s00068-016-0727-9. Epub 2016 Oct 5.

  PMID: 27709248 BACKGROUND

• Cannon B, Chan L, Rowlinson JS, Baker M, Clancy M. Digital anaesthesia: one injection or two? Emerg Med J. 2010 Jul;27(7):533-6. doi: 10.1136/emj.2009.072850. Epub 2010 Apr 1.

  PMID: 20360491 BACKGROUND

MeSH Terms

Conditions

Hand Injuries

Interventions

Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Sean Morell, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Each participant will collect two syringes with a code indicting the order and technique of injection. The contents of the syringe (lidocaine vs normal saline) will not be known by the care provider, outcomes assessor or participant.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Our study design is a two-period cross-over design with four groups defined by order of treatment, in which each subject will experience both injection techniques, one to each hand.

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 15, 2022
• Study Start: September 20, 2023
• Primary Completion: September 20, 2023
• Study Completion: September 20, 2023
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)