Traditional Dorsal Digital Block Vs Volar Subcutaneous Digital Block

November 14, 2024 updated by: University of Arkansas

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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:

  1. Which technique do participants use for digital blocks?
  2. How many mLs of lidocaine do participants use for digital block of one finger?
  3. 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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: V1 Lidocaine, D2 Saline
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
Volar digital block with lidocaine
Procedure: Dorsal digital block with saline
Dorsal digital block with saline
Other: V1 Saline, D2 Lidocaine
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
Volar digital block with saline
Procedure: Dorsal digital block with lidocaine
Dorsal digital block with lidocaine
Other: D1 Lidocaine, V2 Saline
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
Volar digital block with saline
Procedure: Dorsal digital block with lidocaine
Dorsal digital block with lidocaine
Other: D1 Saline, V2 Lidocaine
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
Volar digital block with lidocaine
Procedure: Dorsal digital block with saline
Dorsal digital block with saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately upon injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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).
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Investigators

  • Principal Investigator: Sean Morell, MD, University of Arkansas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2023

Primary Completion (Actual)

September 20, 2023

Study Completion (Actual)

September 20, 2023

Study Registration Dates

First Submitted

March 4, 2022

First Submitted That Met QC Criteria

March 4, 2022

First Posted (Actual)

March 15, 2022

Study Record Updates

Last Update Posted (Estimated)

November 18, 2024

Last Update Submitted That Met QC Criteria

November 14, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 274026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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