Ultrasound Guided Local Anesthetic Block: Thoracolumbar Interfascial Plane

Phase 1

Completed

• Conditions: Healthy
• Interventions: Procedure: Thoracolumbar Interfascial Plane Block; Drug: Ropivicaine

• Registration Number: NCT02297191
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-28
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-21
• Status Verified: 2016-03
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Healthy Adult

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thoracolumbar Interfascial Plane Block	Thoracolumbar Interfascial Plane Block	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
Thoracolumbar Interfascial Plane Block	Ropivicaine	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

Primary Outcome Measures

Name	Time	Method
Anesthesia (monitoring of pain, temperature, and adverse reaction to anesthesia [tinnitus, disorientation, or perioral numbness])	The day of procedure (up to 15 minutes)	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.; 1. Photos will only include surface anatomy of the low-to-mid back.; 2. Participants will be assessed for evidence of adverse reaction to local anesthesia (tinnitus, disorientation, or perioral numbness) with each 5cc dose of local anesthetic.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States