The Use of Micro Vibratory Stimulation Technique to Control the Pain of Digit Block Anesthesia

August 12, 2016 updated by: Christus Spohn Memorial Medical Center
The investigators hypothesize that patients who receive 1% lidocaine injections for digit blocks of the finger will experience less pain when the injection is accompanied by the use of a micro-vibratory stimulator (MVS) compared with patients who receive injections without the MVS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Research Question/Hypothesis

The investigators hypothesize that patients who receive 1% lidocaine injections for digit blocks of the finger will experience less pain when the injection is accompanied by the use of a micro-vibratory stimulator (MVS) compared with patients who receive injections without the MVS.

Objectives

The primary objective of this study is to compare the pain rating scale from an exposure group (digit block injection with the aid MVS) and the control group (traditional injection).

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

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 to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy individuals between the ages of 18 and 65 who are willing and able to consent and who require the use of local anesthetic digit block to both sides of a finger for the treatment of wounds, injuries, infections, or laceration of the fingers.

Exclusion Criteria:

  • Allergy to any type of local anesthetic.
  • Inability to Consent.
  • Inability to complete a numeric pain scale.
  • Clinical appearance or clinical evidence of intoxication.
  • Significant compromising conditions such as major trauma and severe respiratory distress.

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: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Parallel lidocaine injection
Informed consent will be obtained from patients undergoing finger local anesthesia digit blocks. Subjects will be randomly assigned (using GraphPAD Randomization Software Tool) to receive the first of their two digit block injections with either the traditional technique (control) or while using the DVICS/ Microvibratory Stimulator. All injections will utilize a 27-gauge needle. The subjects will be given a standard dose of 2mls of 1% lidocaine without epinephrine delivered over 30 seconds. Injections will be timed and performed by a single clinician to avoid large variations in technique and expertise.
Device: Microvibratory Stimulator
Informed consent will be obtained from patients undergoing finger local anesthesia digit blocks. Subjects will be randomly assigned (using GraphPAD Randomization Software Tool) to receive the first of their two digit block injections with either the traditional technique (control) or while using the DVICS/ Microvibratory Stimulator. All injections will utilize a 27-gauge needle. The subjects will be given a standard dose of 2mls of 1% lidocaine without epinephrine delivered over 30 seconds. Injections will be timed and performed by a single clinician to avoid large variations in technique and expertise.
Device: Microvibratory Stimulator'
As above, Microvibratory Stimulator will be used as a sham device in parallel group.
SHAM_COMPARATOR: Parallel
In the sham comparator, the device will be placed on the skin, but not turned on. Digit block anesthesia will progress in usual fashion as with active comparator, except without the vibratory device engaged.
Device: Microvibratory Stimulator
Informed consent will be obtained from patients undergoing finger local anesthesia digit blocks. Subjects will be randomly assigned (using GraphPAD Randomization Software Tool) to receive the first of their two digit block injections with either the traditional technique (control) or while using the DVICS/ Microvibratory Stimulator. All injections will utilize a 27-gauge needle. The subjects will be given a standard dose of 2mls of 1% lidocaine without epinephrine delivered over 30 seconds. Injections will be timed and performed by a single clinician to avoid large variations in technique and expertise.
Device: Microvibratory Stimulator'
As above, Microvibratory Stimulator will be used as a sham device in parallel group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain associated with injection of lidocaine
Time Frame: 30 seconds
Subjects will rate pain of injection using a 0-10 VAS
30 seconds

Collaborators and Investigators

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

Sponsor

Christus Spohn Memorial Medical Center

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

June 1, 2014

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

August 12, 2016

First Posted (ESTIMATE)

August 17, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 17, 2016

Last Update Submitted That Met QC Criteria

August 12, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 14-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data to be published

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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