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OpenTrials
Completed

NCT Number: NCT02870595

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

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.

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Key information

Conditions

Pain, Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Microvibratory Stimulator

Device

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.

Microvibratory Stimulator'

Device

As above, Microvibratory Stimulator will be used as a sham device in parallel group.

Primary outcomes

  1. Pain associated with injection of lidocaine

    Time frame: 30 seconds

    Subjects will rate pain of injection using a 0-10 VAS

Sponsors and collaborators

Lead sponsor

Christus Spohn Memorial Medical Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 17, 2016
Registry last updated
Aug 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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