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

Christus Spohn Memorial Medical Center

Status: Completed

Conditions: Pain, Analgesia

Treatments: Device: Microvibratory Stimulator; Device: Microvibratory Stimulator'

Study type: Interventional

Funder types: Other

Identifiers

NCT02870595

14-007

Details and patient eligibility

About

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.

Full 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).

Enrollment: 25 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Parallel lidocaine injection

Active Comparator group

Description:

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.

Treatment:

Device: Microvibratory Stimulator

Device: Microvibratory Stimulator'

Parallel

Sham Comparator group

Description:

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.

Treatment:

Device: Microvibratory Stimulator

Device: Microvibratory Stimulator'