Distribution, Pharmacokinetics and Extent of Sensory Blockade in ESP Blocks

Phase 4

Completed

Conditions: Distribution of Ropivacaine in Erector Spinae Plane Block

Interventions: Drug: Ropivacaine
Drug: Epinephrine

Registration Number: NCT03476642

Lead Sponsor: Milton S. Hershey Medical Center

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 12

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine with Epinephrine	Ropivacaine	Group RE will have 20mL of 0.5% Ropivacaine with epinephrine injected at the left or right T5 transverse process.
Ropivacaine with Epinephrine	Epinephrine	Group RE will have 20mL of 0.5% Ropivacaine with epinephrine injected at the left or right T5 transverse process.
Ropivacaine without Epinephrine	Ropivacaine	Group R will have 20mL of 0.5% Ropivacaine without epinephrine injected at the left or right T5 transverse process.

Primary Outcome Measures

Name	Time	Method
Area of Dermatomal Sensory Loss at 20 Min	20 minutes from the time of the ESP block	A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin
Area of Dermatomal Sensory Loss 60 Min	60 minutes from the time of the ESP block	A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin
Area of Dermatomal Sensory Loss 120 Min	120 minutes from the time of the ESP block	A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin
Area of Dermatomal Sensory Loss at 240 Min	240 minutes from the time of the ESP block	A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin
Area of Dermatomal Sensory Loss 360 Min	360 minutes from the time of the ESP block	A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin
Venous Plasma Concentration of Ropivacaine at 20 Min	These samples will be repeated at 20 minutes after completion of the injection of active drug.	3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.
Venous Plasma Concentration of Ropivacaine at 60 Min	These samples will be repeated at 60 minutes after completion of the injection of active drug.	3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.
Venous Plasma Concentration of Ropivacaine at 90 Min	These samples will be repeated at 90 minutes after completion of the injection of active drug.	3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.
Venous Plasma Concentration of Ropivacaine at 120 Min	These samples will be repeated at 120 after completion of the injection of active drug.	3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.
Venous Plasma Concentration of Ropivacaine at 240 Min	These samples will be repeated at 240 minutes after completion of the injection of active drug.	3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.
Volume of Injectate Spread Measured Using MRI at 30 Min	30 minutes from the time of the ESP block	The subject will undergo two MRIs to determine the spread of the anesthetic.
Volume of Injectate Spread Measured Using MRI at 90 Min	90 minutes from the time of the ESP block	The subject will undergo two MRIs to determine the spread of the anesthetic.