Hand InjuriesNCT05280704
Traditional Dorsal Digital Block Vs Volar Subcutaneous Digital Block
A study testing Volar digital block with lidocaine, Volar digital block with saline and Dorsal digital block with lidocaine in people with Hand Injuries, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hand Injuries
- What is being tested?
- Volar digital block with lidocaine, Volar digital block with saline and Dorsal digital block with lidocaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2023to 20 Sep 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
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.
Read the 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.
- Conditions
- Hand Injuries
- Being tested
- Volar digital block with lidocaine, Volar digital block with saline, Dorsal digital block with lidocaine, Dorsal digital block with saline
- Keywords
- digital block
- Medical subject headings
- Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volar digital block with lidocaineProcedure or surgery
Volar digital block with lidocaine
Volar digital block with salineProcedure or surgery
Volar digital block with saline
Dorsal digital block with lidocaineProcedure or surgery
Dorsal digital block with lidocaine
Dorsal digital block with salineProcedure or surgery
Dorsal digital block with saline
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: Volar digital block with lidocaine; Procedure: Dorsal digital block with saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately upon injection
Secondary outcomes (1)
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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start20 Sep 2023
- Primary completion20 Sep 2023
- Study completion20 Sep 2023
Why it stopped: Slow accrual and other non-safety related issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Hand InjuriesStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sean Morell, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280704
- Sponsor's protocol ID
- 274026
- Status last verified
- Nov 2024
- First submitted
- 4 Mar 2022
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 33895422Whetzel 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.
PubMed 9195442Cummings 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 14751102Braun H, Harris ML. Operations on the extremities. In: Local Anesthesia: It's Scientific Basis and Practical Use. 2nd ed. Lea & Febiger; 1924:366-367.
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.
PubMed 17016190Harbison 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.
PubMed 1940182Yin 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.
PubMed 16930788Bashir 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.
PubMed 19032891Martin 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.
PubMed 26991958Afridi 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.
PubMed 25358227Okur 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.
PubMed 27709248Cannon 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.
PubMed 20360491
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Dorsal Digital Block Vs Volar Subcutaneous Digital Block
- ClinicalTrials.gov ID
- NCT05280704
- Acronym / sponsor ID
- 274026
- Conditions
- Hand Injuries
- Keywords
- digital block
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual and other non-safety related issues
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| V1 Lidocaine, D2 Saline | Other | Procedure: Volar digital block with lidocaine, Procedure: Dorsal digital block with salineWill 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. |
| V1 Saline, D2 Lidocaine | Other | Procedure: Volar digital block with saline, Procedure: Dorsal digital block with lidocaineWill 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. |
| D1 Lidocaine, V2 Saline | Other | Procedure: Volar digital block with saline, Procedure: Dorsal digital block with lidocaineWill 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. |
| D1 Saline, V2 Lidocaine | Other | Procedure: Volar digital block with lidocaine, Procedure: Dorsal digital block with salineWill 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- Participants with absence of an index finger on either side
- Pregnancy
- Neuropathy
- Hematologic disease
- Peripheral vascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volar digital block with lidocaineVolar digital block with lidocaine | Procedure or surgery | D1 Saline, V2 Lidocaine, V1 Lidocaine, D2 Saline |
| Volar digital block with salineVolar digital block with saline | Procedure or surgery | D1 Lidocaine, V2 Saline, V1 Saline, D2 Lidocaine |
| Dorsal digital block with lidocaineDorsal digital block with lidocaine | Procedure or surgery | D1 Lidocaine, V2 Saline, V1 Saline, D2 Lidocaine |
| Dorsal digital block with salineDorsal digital block with saline | Procedure or surgery | D1 Saline, V2 Lidocaine, V1 Lidocaine, D2 Saline |
Primary outcome
Injection Pain
Time frame: Immediately upon injection
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.
1 secondary outcome
Efficacy of Desensitization
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.
Results and safety
The study was stopped early (reason given: Slow accrual and other non-safety related issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Background: PubMed 33895422Ito 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.
- Background: PubMed 9195442Whetzel 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.
- Background: PubMed 14751102Cummings 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.
- BackgroundBraun 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: PubMed 17016190Williams 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.
- Background: PubMed 1940182Harbison 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.
- Background: PubMed 16930788Yin 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.
- Background: PubMed 19032891Bashir 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.
- Background: PubMed 26991958Martin 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.
- Background: PubMed 25358227Afridi 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.
- Background: PubMed 27709248Okur 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.
- Background: PubMed 20360491Cannon 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.
- Individual participant dataSharing planned: No. 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.
Related trials for Hand Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Not yet recruiting
Accessible Remote Rehabilitation System for Real-Time Biomechanical Monitoring
Hand Injury Rehabilitation, Postoperative Rehabilitation
Recruiting
Conservative Treatment With Relative Motion Flexion Orthosis for Boutonniere Injuries in Fingers
Finger Joint Deformities, Tendon Injuries
Not yet recruiting
Influence of Transcranial Electrical Stimulation on Arm and Hand Function After Cervical Spinal Cord Injury
Spinal Cord Injury
Recruiting
Vibratory Anesthesia on Pain Following Corticosteroid Injections
Bilateral Arthritis of Wrist, Tendinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Morell, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volar digital block with lidocaine, Volar digital block with saline and Dorsal digital block with lidocaine in people with Hand Injuries, run by University of Arkansas 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 1 inclusion and 6 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: stopped early, as of the sponsor's last update on 18 Nov 2024. 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.
Are results available for this study?
The study was stopped early (reason given: Slow accrual and other non-safety related issues). Results are not available in the source record.
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?
Injection Pain (time frame: Immediately upon injection). 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 NCT05280704, which also lists 12 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 18 Nov 2024.