NCT02297191

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
Last Updated

June 20, 2018

Status Verified

March 1, 2016

Enrollment Period

4 months

First QC Date

July 28, 2014

Last Update Submit

June 18, 2018

Conditions

Healthy

Keywords

volunteerpilot studyadults

Outcome Measures

Primary Outcomes (1)

  • 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. 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.

    The day of procedure (up to 15 minutes)

Study Arms (1)

Thoracolumbar Interfascial Plane Block

EXPERIMENTAL

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 BlockDrug: Ropivicaine

Interventions

Thoracolumbar Interfascial Plane BlockPROCEDURE

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.

Thoracolumbar Interfascial Plane Block
RopivicaineDRUG
Thoracolumbar Interfascial Plane Block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy Adult

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

  • 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.

    PMID: 26149600DERIVED

Study Officials

  • William Hand, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

  • Scott T Reeves, MD

    Medical University of South Carolina

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2014

First Posted

November 21, 2014

Study Start

July 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

June 20, 2018

Record last verified: 2016-03

Locations

US(1)