Ultrasound Guided Local Anesthetic Block: Thoracolumbar Interfascial Plane

Study Overview
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Brief Summary
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The purpose of the study is to determine the effectiveness of a new approach to numbing (anesthetizing) nerves in the back and to measure how far the area of anesthesia extends on the skin of the back.

Detailed Description
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This research aims to define a novel field-infiltration nerve block. We will use ultrasound guidance to inject local anesthesia into the potential space between the muscle bodies of the erector spinae. The medial branch of the dorsal ramus of each thoracolumbar nerve innervates the muscle and skin overlying the erector spinae muscle to the midline. By anesthetizing each nerve we believe minimally invasive (1-2 level) back surgery may be completed with less pain and preclude the side-effect laden opioid analgesics.

Official Title
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Ultrasound Guided Local Anesthetic Field Block Within the Thoracolumbar Interfascial Plane: Distribution of Pain and Temperature Sensation Loss in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Procedure: Thoracolumbar Interfascial Plane Block
* Drug: Ropivicaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Adult Exclusion Criteria: Pregnant women (a urine pregnancy test will be done on all females of childbearing age) Liver dysfunction Elderly Impaired cardiovascular function Individuals on amiodarone or history of back surgery History of medical allergy to local amide type local anesthetics Medical allergy to chlorhexidine History of paresthesias Inability to lay flat Home oxygen requirement History of seizures Only adults will be eligible.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thoracolumbar Interfascial Plane Block<br>All participants will have two injections at the same vertebral level on each side of the back. Each injection will consist of four 5cc incremental injections with aspiration prior to each 5cc of injectate of 0.5% Ropivicaine. . Each side of the back will be injected with 20cc of .05% Ropivicaine. Ultrasound will be used in real time to guide the needle, evaluate for spread of local anesthesia and to minimize the risk of Ropivicaine being injected intravascularly. a. Ultrasound images will be saved using the nomenclature TLIP Anat | Procedure: Thoracolumbar Interfascial Plane Block<br>* All participants will have two injections at the same vertebral level on each side of the back. Each injection will consist of four 5cc incremental injections with aspiration prior to each 5cc of injectate of 0.5% Ropivicaine. . Each side of the back will be injected with 20cc of .05% Ropivicaine. Ultrasound will be used in real time to guide the needle. Ultrasound images will be saved using the nomenclature TLIP Anatomy Photos will only include surface anatomy of the low-to-mid back. Participants will be assessed for evidence of adverse reaction to local anesthesia (tinnitus, disorientation, or perioral numbness) with each 5cc dose of local anesthetic. If any adverse reactions are noted the dosing will be stopped.<br>Drug: Ropivicaine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anesthesia (monitoring of pain, temperature, and adverse reaction to anesthesia [tinnitus, disorientation, or perioral numbness]) | At time zero (pre injection), 5 minutes, and 15 minutes point-discrimination to pain and temperature will be evaluated by blunt-needle prick and ice (in plastic bag). A map of each will be drawn and photographed for analysis. Photos will only include surface anatomy of the low-to-mid back. Participants will be assessed for evidence of adverse reaction to local anesthesia (tinnitus, disorientation, or perioral numbness) with each 5cc dose of local anesthetic. | The day of procedure (up to 15 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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volunteer, pilot study, adults