Distribution, Pharmacokinetics and Extent of Sensory Blockade in ESP Blocks

April 16, 2025 updated by: Sanjib D Adhikary, Milton S. Hershey Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
20 minutes from the time of the ESP block
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
60 minutes from the time of the ESP block
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
120 minutes from the time of the ESP block
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
240 minutes from the time of the ESP block
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
360 minutes from the time of the ESP block
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.
These samples will be repeated at 20 minutes after completion of the injection of active drug.
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.
These samples will be repeated at 60 minutes after completion of the injection of active drug.
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.
These samples will be repeated at 90 minutes after completion of the injection of active drug.
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.
These samples will be repeated at 120 after completion of the injection of active drug.
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.
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
Time Frame: 30 minutes from the time of the ESP block
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
Time Frame: 90 minutes from the time of the ESP block
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood pressure at periodic time intervals
Time Frame: Up to 360 minutes from the time of the ESP block
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
Time Frame: 0-3 days after the block is complete
0-3 days after the block is complete
ECG at periodic time intervals
Time Frame: Up to 360 minutes from the time of the ESP block
Recording ECG every 5 minutes
Up to 360 minutes from the time of the ESP block

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Milton S. Hershey Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sanjib Adhikary, MD, Milton S. Hershey Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 2, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 19, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Distribution of Ropivacaine in Erector Spinae Plane Block

Clinical Trials on Ropivacaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings