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Traditional Dorsal Digital Block vs Volar Subcutaneous Digital Block

Primary Purpose

Hand Injuries

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Volar digital block with lidocaine
Volar digital block with saline
Dorsal digital block with lidocaine
Dorsal digital block with saline
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hand Injuries focused on measuring digital block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

V1 Lidocaine, D2 Saline

V1 Saline, D2 Lidocaine

D1 Lidocaine, V2 Saline

D1 Saline, V2 Lidocaine

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Efficacy of Desensitization
Time to loss of sensation in all 12 finger zones will be right-censored at the 15-minute mark, graphed as Kaplan-Meier curves, and, depending on distributional characteristics, compared for a Volar-versus-Dorsal difference using either the log-rank test or the Gehan-Wilcoxon test at P<0.05 (2-sided).

Full Information

First Posted
March 4, 2022
Last Updated
August 24, 2023
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT05280704
Brief Title
Traditional Dorsal Digital Block vs Volar Subcutaneous Digital Block
Official Title
Traditional Dorsal Digital Block vs Volar Subcutaneous Digital Block
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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 described by Cummings et al 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. Set Up Prior to Study Performance Four-digit codes will be created for all participants. The 4-digit codes will be randomly assigned to a treatment group, A, B, C and D. Group A will undergo the volar technique first with lidocaine (V1) and then the dorsal technique second with sterile saline (D2). Group B will undergo the volar technique first with sterile saline and then undergo the second injection with the dorsal technique with lidocaine. Group C will undergo the dorsal technique first with lidocaine (D1) and then the volar technique second with sterile saline (V2). Group D will undergo the dorsal technique first with sterile saline followed by the volar technique second with lidocaine. Two syringes will be prepared for each 4-digit code, one with 4 mL of 1% lidocaine and 4 mL of sterile normal saline. They will be labelled with the four-digit code and a separate letter-digit code. The letter-digit code will contain one letter, either V or D, and one number, 1 or 2. The letter corresponds to the technique used to perform the injection (V for volar technique, D for traditional dorsal technique). The number corresponds to the order to which the syringe is to be used, first or second. Figure 1 shows a typical example of how a syringe will be labelled. In this example, participant 4883 in Group A would receive a syringe of lidocaine labelled 4883 V1 and a syringe of saline labelled 4883 D2. Each syringe will also be marked with an * indicating lidocaine and a # indicating sterile saline. This is added to the syringes to immediately determine the syringe contents in case of adverse reaction. The meaning of the * and # will not be shared with participants but will be known to all members of the study team. Date of Study An anonymous survey will be given to all participants with three questions: Which technique do participants use for digital blocks? How many mLs of lidocaine do participants use for digital block of one finger? What specialty of medicine do participants practice? A ten-minute instructional demonstration will be performed demonstrating the volar injection technique and the traditional dorsal digital block technique as well as explaining the pain visual analog scale, the 12 zones of the finger, and how to record the data. Participants will collect their two syringes with the same four-digit code. They will not be told that one syringe contains normal saline. Participants will then pair into groups of three. Within a group of three, each participant will be assigned the role of subject, injector, or recorder. The recorder will record the 4- digit number code at the top of the data sheet for the subject prior to injection. The injector will prep the base of the subject's index finger and perform the digital block in a sterile fashion using the technique indicated by letter on the syringe labeled 1. The recorder will start the timer. Pain on injection using the Visual Analog Score (VAS) will be recorded. 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. The injector will then prep the base of the index finger on the subject's other hand and proceed with the second digital block using the technique corresponding to the letter on the syringe labelled 2. Again, pain on injection using the VAS will be recorded, 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 of the finger. Subject will then record which injection they prefer based on the pain on injection, not on the efficacy of technique at achieving loss of sensation. The participants will switch, so that the injector will become the subject, the recorder will become the injector, the subject will become the recorder, and the above-described procedure will be repeated. Then the participants will switch once more, and same procedure will be conducted a third and final time. If the injector in the final round has an insensate index finger, then an injector from another group with a sensate digit will perform the injections. Participants may withdraw from the study at any time without prejudice to their training. Under certain circumstances the researchers may terminate the participant's participation in the study if: the participant is found to meet exclusion criteria, it is not in the participant's best interest to continue, or the study is stopped for any reason.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Injuries
Keywords
digital block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
V1 Lidocaine, D2 Saline
Arm Type
Other
Arm Description
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.
Arm Title
V1 Saline, D2 Lidocaine
Arm Type
Other
Arm Description
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.
Arm Title
D1 Lidocaine, V2 Saline
Arm Type
Other
Arm Description
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.
Arm Title
D1 Saline, V2 Lidocaine
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Volar digital block with lidocaine
Intervention Description
Volar digital block with lidocaine
Intervention Type
Procedure
Intervention Name(s)
Volar digital block with saline
Intervention Description
Volar digital block with saline
Intervention Type
Procedure
Intervention Name(s)
Dorsal digital block with lidocaine
Intervention Description
Dorsal digital block with lidocaine
Intervention Type
Procedure
Intervention Name(s)
Dorsal digital block with saline
Intervention Description
Dorsal digital block with saline
Primary Outcome Measure Information:
Title
Injection Pain
Description
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.
Time Frame
Immediately upon injection
Secondary Outcome Measure Information:
Title
Efficacy of Desensitization
Description
Time to loss of sensation in all 12 finger zones will be right-censored at the 15-minute mark, graphed as Kaplan-Meier curves, and, depending on distributional characteristics, compared for a Volar-versus-Dorsal difference using either the log-rank test or the Gehan-Wilcoxon test at P<0.05 (2-sided).
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dana L Garrison, MA
Phone
501-526-6534
Email
dlgarrison@uams.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandria L Smith, MD
Phone
501-686-7500
Email
Asmith8@uams.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Morell, MD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana L Garrison, MA
Phone
501-526-6534
Email
dlgarrison@uams.edu
First Name & Middle Initial & Last Name & Degree
Alexandria L Smith, MD
Phone
5016867500
Email
Asmith8@uams.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Upon enrollment, each study participant will be assigned a unique identifying code (Participant ID), which will be used in place of their name on study documents to create a de-identified dataset. The key to this code will be kept separately from study data and will be stored in a locked file in Orthopedics office at UAMS. Only study personnel will have access to the code and any information that identifies the participant in this study. Once accepted for publication, the documents containing the unique study codes associated with the subjects' names will be destroyed.
Citations:
PubMed Identifier
33895422
Citation
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.
Results Reference
background
PubMed Identifier
9195442
Citation
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.
Results Reference
background
PubMed Identifier
14751102
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. doi: 10.1016/j.jhsa.2003.09.018.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
17016190
Citation
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.
Results Reference
background
PubMed Identifier
1940182
Citation
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.
Results Reference
background
PubMed Identifier
16930788
Citation
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.
Results Reference
background
PubMed Identifier
19032891
Citation
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.
Results Reference
background
PubMed Identifier
26991958
Citation
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.
Results Reference
background
PubMed Identifier
25358227
Citation
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.
Results Reference
background
PubMed Identifier
27709248
Citation
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.
Results Reference
background
PubMed Identifier
20360491
Citation
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.
Results Reference
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Traditional Dorsal Digital Block vs Volar Subcutaneous Digital Block

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