Ultrasound Guided Local Anesthetic Block: Thoracolumbar Interfascial Plane (TLIP)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Procedure: Thoracolumbar Interfascial Plane Block; Drug: Ropivicaine

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Procedure: 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.; 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.; Drug: Ropivicaine

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: William Hand, MD, Medical University of South Carolina

Publications and helpful links

General Publications

• Hand WR, Taylor JM, Harvey NR, Epperson TI, Gunselman RJ, Bolin ED, Whiteley J. Thoracolumbar interfascial plane (TLIP) block: a pilot study in volunteers. Can J Anaesth. 2015 Nov;62(11):1196-200. doi: 10.1007/s12630-015-0431-y. Epub 2015 Jul 7.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: July 28, 2014
• First Submitted That Met QC Criteria: November 20, 2014
• First Posted (Estimate): November 21, 2014

Study Record Updates

• Last Update Posted (Actual): June 20, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: pilot study; adults; volunteer
• Other Study ID Numbers: TLIP Block; Pro00033609 (Other Identifier: Medical University of South Carolina)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No