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Distribution, Pharmacokinetics and Extent of Sensory Blockade in ESP Blocks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03476642
Recruitment Status : Suspended (Temporarily suspended due to Pandemic.)
First Posted : March 26, 2018
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Sanjib D Adhikary, 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.


Condition or disease Intervention/treatment Phase
Distribution of Ropivacaine in Erector Spinae Plane Block Drug: Ropivacaine Drug: Epinephrine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This will be a randomized,double blinded, controlled study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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.
Actual Study Start Date : July 2, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


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




Primary Outcome Measures :
  1. Extent of dermatomal sensory loss [ Time Frame: 0 to 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

  2. Duration of sensory loss [ Time Frame: 0 to 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

  3. Anatomical extent of injectate spread using MRI [ Time Frame: 30 and 90 minutes from the time of the ESP block ]
    The subject will undergo two MRIs to determine the spread of the anesthetic.

  4. Venous plasma concentration of ropivacaine at periodic time intervals [ Time Frame: These samples will be repeated at 20, 40, 60, 90, 120, and 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.


Secondary Outcome Measures :
  1. 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.

  2. Any adverse effects or side effects related to injection of the medications [ Time Frame: 0-3 days after the block is complete ]
  3. ECG at periodic time intervals [ Time Frame: Up to 360 minutes from the time of the ESP block ]
    Recording ECG every 5 minutes



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03476642


Locations
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United States, Pennsylvania
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Sanjib Adhikary, MD Milton S. Hershey Medical Center
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Responsible Party: Sanjib D Adhikary, Associate Professor, Director Acute Pain, Regional Anesthesia/Ortho, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03476642    
Other Study ID Numbers: STUDY0008641
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Epinephrine
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents