Distribution, Pharmacokinetics and Extent of Sensory Blockade in ESP Blocks

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.

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.

Study Overview

• Status: Completed
• Conditions: Distribution of Ropivacaine in Erector Spinae Plane Block
• Intervention / Treatment: Drug: Ropivacaine; Drug: Epinephrine

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Milton S.Hershey Medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ropivacaine with Epinephrine; Group RE will have 20mL of 0.5% Ropivacaine with epinephrine injected at the left or right T5 transverse process.	Drug: Ropivacaine; injection of 20mL of 0.5% Ropivacaine at the left or right T5 transverse process; Drug: Epinephrine; injection of 20mL epinephrine in combination with ropivacaine at the left or right T5 transverse process
Active Comparator: Ropivacaine without Epinephrine; Group R will have 20mL of 0.5% Ropivacaine without epinephrine injected at the left or right T5 transverse process.	Drug: Ropivacaine; injection of 20mL of 0.5% Ropivacaine at the left or right T5 transverse process

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure at periodic time intervals	Non- invasive monitoring of blood pressure every 5 minutes.	Up to 360 minutes from the time of the ESP block
Any adverse effects or side effects related to injection of the medications		0-3 days after the block is complete
ECG at periodic time intervals	Recording ECG every 5 minutes	Up to 360 minutes from the time of the ESP block

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: Sanjib Adhikary, MD, Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2019
• Primary Completion (Actual): February 19, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: March 22, 2018
• First Posted (Actual): March 26, 2018

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Neurotransmitter Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Ropivacaine; Epinephrine
• Other Study ID Numbers: STUDY0008641

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No