Milton S.Hershey Medical center
Hershey, Pennsylvania, 17033, United States
Completed
NCT Number: NCT03476642
Distribution, Pharmacokinetics and Extent of Sensory Blockade in ESP Blocks
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.
Completed
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Notify MeKey information
Age range
18 year–60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Ropivacaine
Druginjection of 20mL of 0.5% Ropivacaine at the left or right T5 transverse process
Epinephrine
Druginjection of 20mL epinephrine in combination with ropivacaine at the left or right T5 transverse process
Primary outcomes
-
Area of Dermatomal Sensory Loss at 20 Min
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 90 minutes from the time of the ESP block
The subject will undergo two MRIs to determine the spread of the anesthetic.
Sponsors and collaborators
Lead sponsor
Milton S. Hershey Medical Center
Other
Registry information
Official study 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.
Important dates
- Study start
- 2019
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- Mar 26, 2018
- Registry last updated
- May 2, 2025
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.