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Completed

NCT Number: NCT02297191

Ultrasound Guided Local Anesthetic Block: Thoracolumbar Interfascial Plane

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thoracolumbar interfascial plane block

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.

  • 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.

ropivicaine

Drug

Primary outcomes

  1. Anesthesia (monitoring of pain, temperature, and adverse reaction to anesthesia [tinnitus, disorientation, or perioral numbness])

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Acronym: TLIP

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Nov 21, 2014
Registry last updated
Jun 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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