TLIP: Ultrasound Guided Local Anesthetic Block: Thoracolumbar Interfascial Plane

Sponsor

Medical University of South Carolina (Other)

Overall Status

Completed

CT.gov ID

NCT02297191

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Procedure: Thoracolumbar Interfascial Plane Block Drug: Ropivicaine	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Nov 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

Medical University of South Carolina

Investigators

Principal Investigator: William Hand, MD, Medical University of South Carolina
Study Chair: Scott T Reeves, MD, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT02297191

Other Study ID Numbers:

TLIP Block
Pro00033609

First Posted:

Nov 21, 2014

Last Update Posted:

Jun 20, 2018

Last Verified:

Mar 1, 2016

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Medical University of South Carolina

volunteer

pilot study

adults

Study Results

No Results Posted as of Jun 20, 2018