Clinical trial NCT03476642: Distribution, Pharmacokinetics and Extent of Sensory Blockade in ESP Blocks
Official title: A Volunteer Study to Determine the Anatomical Distribution of Injectate, the Extent of Sensory Block, and the Pharmacokinetics of Ropivacaine Following Erector Spinae Plane (ESP) Blocks.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Distribution of Ropivacaine in Erector Spinae Plane Block
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a randomized,double blinded, controlled study.
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objectives of this study are to define the extent of dermatomal anesthesia and anatomical spread of injectate (as defined by MRI imaging) that is provided by an ESP block at the T5 level, using twenty milliliters of 0.5% ropivacaine.

The secondary objectives include: 1) the measurement of changes in hemodynamic parameters associated with the ESP block, 2) the duration of sensory effects provided by ropivacaine with or without epinephrine, 3) the venous plasma concentration of ropivacaine associated at various time intervals after completion of the ESP block.


Eligibility criteria: Inclusion Criteria:

* Healthy adults aged 18 to 60 inclusive
* Weight between 60 and 100 kg inclusive
* Height 160 to190 cm inclusive

Exclusion Criteria:

* Pregnant females
* Chronic medical condition requiring medication
* History of previous major spinal, abdominal or thoracic surgery
* Congenital abnormalities of the spine, back, thorax or abdomen
* History of major trauma to the thorax or abdomen;
* Allergy to ropivacaine or other amide local anesthetics
* The presence of any metallic implant in their body
* Any contraindication to magnetic resonance imaging as determined by completion of a standard questionnaire administered to all patients undergoing magnetic resonance imaging.
* Allergy to Gadolinium radiological contrast agent.

Primary outcomes:
measure: Area of Dermatomal Sensory Loss at 20 Min
timeFrame: 20 minutes from the time of the ESP block
measure: Area of Dermatomal Sensory Loss 60 Min
timeFrame: 60 minutes from the time of the ESP block
measure: Area of Dermatomal Sensory Loss 120 Min
timeFrame: 120 minutes from the time of the ESP block
measure: Area of Dermatomal Sensory Loss at 240 Min
timeFrame: 240 minutes from the time of the ESP block
measure: Area of Dermatomal Sensory Loss 360 Min
timeFrame: 360 minutes from the time of the ESP block
measure: Venous Plasma Concentration of Ropivacaine at 20 Min
timeFrame: These samples will be repeated at 20 minutes after completion of the injection of active drug.
measure: Venous Plasma Concentration of Ropivacaine at 60 Min
timeFrame: These samples will be repeated at 60 minutes after completion of the injection of active drug.
measure: Venous Plasma Concentration of Ropivacaine at 90 Min
timeFrame: These samples will be repeated at 90 minutes after completion of the injection of active drug.
measure: Venous Plasma Concentration of Ropivacaine at 120 Min
timeFrame: These samples will be repeated at 120 after completion of the injection of active drug.
measure: Venous Plasma Concentration of Ropivacaine at 240 Min
timeFrame: These samples will be repeated at 240 minutes after completion of the injection of active drug.
measure: Volume of Injectate Spread Measured Using MRI at 30 Min
timeFrame: 30 minutes from the time of the ESP block
measure: Volume of Injectate Spread Measured Using MRI at 90 Min
timeFrame: 90 minutes from the time of the ESP block
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Milton S.Hershey Medical center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Sanjib Adhikary, MD
role: PRINCIPAL_INVESTIGATOR
References: