Healthy
Conditions
Keywords
volunteer, pilot study, adults
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.
Interventions
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.
DRUGRopivicaine
Sponsors
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. 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. |
Countries
United States
Outcome results
None listed