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Distribution, Pharmacokinetics and Extent of Sensory Blockade in ESP Blocks

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ClinicalTrials.gov Identifier: NCT03476642
Recruitment Status : Suspended (Temporarily suspended due to Pandemic.)
First Posted : March 26, 2018
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
Sanjib D Adhikary, Milton S. Hershey Medical Center

Tracking Information
First Submitted Date  ICMJE March 1, 2018
First Posted Date  ICMJE March 26, 2018
Last Update Posted Date February 24, 2021
Actual Study Start Date  ICMJE July 2, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2018)
  • 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
  • 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
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2018)
  • 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.
  • Any adverse effects or side effects related to injection of the medications [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Distribution, Pharmacokinetics and Extent of Sensory Blockade in ESP Blocks
Official Title  ICMJE 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.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Distribution of Ropivacaine in Erector Spinae Plane Block
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Ropivacaine
    • Drug: Epinephrine
  • 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.
    Intervention: Drug: Ropivacaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: March 22, 2018)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03476642
Other Study ID Numbers  ICMJE STUDY0008641
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sanjib D Adhikary, Milton S. Hershey Medical Center
Study Sponsor  ICMJE Milton S. Hershey Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sanjib Adhikary, MD Milton S. Hershey Medical Center
PRS Account Milton S. Hershey Medical Center
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP