Ultrasound Guided Local Anesthetic Block: Thoracolumbar Interfascial Plane

NCT ID: NCT02297191

Last Updated: 2018-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2014-11-30

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Thoracolumbar Interfascial Plane Block

Intervention Type: PROCEDURE

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.

1. Ultrasound images will be saved using the nomenclature TLIP Anatomy

2. Photos will only include surface anatomy of the low-to-mid back.

3. 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.

Ropivicaine

Intervention Type: DRUG

Interventions

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.

1. Ultrasound images will be saved using the nomenclature TLIP Anatomy

2. Photos will only include surface anatomy of the low-to-mid back.

3. 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.

Intervention Type: PROCEDURE

Ropivicaine

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Hand, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Scott T Reeves, MD

Role: STUDY_CHAIR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26149600 (View on PubMed)

Other Identifiers

Pro00033609

Identifier Type: OTHER

Identifier Source: secondary_id

TLIP Block

Identifier Type: -

Identifier Source: org_study_id