Distribution, Pharmacokinetics and Extent of Sensory Blockade in ESP Blocks

• ClinicalTrials.gov Identifier: NCT03476642
• Recruitment Status: Recruiting
• First Posted: March 26, 2018
• Last Update Posted: January 30, 2023
• Sponsor: Milton S. Hershey Medical Center
• Information provided by (Responsible Party): Sanjib D Adhikary, Milton S. Hershey Medical Center

Tracking Information

• First Submitted Date: March 1, 2018
• First Posted Date: March 26, 2018
• Last Update Posted Date: January 30, 2023
• Actual Study Start Date: July 2, 2019
• Estimated Primary Completion Date: July 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Distribution, Pharmacokinetics and Extent of Sensory Blockade in ESP Blocks
• 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.

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: Interventional
• Study Phase: Phase 4

Study Design

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: Distribution of Ropivacaine in Erector Spinae Plane Block

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 22, 2018): 24
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2023
• Estimated Primary Completion Date: July 2023 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Sanjib Adhikary, MD; 717-531-6140; sadhikary1@pennstatehealth.psu.edu

Contact: Ruth Jarbadan; 717-531-0003 ext 311372; njarbadan@pennstatehealth.psu.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03476642
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Sanjib D Adhikary, Milton S. Hershey Medical Center
• Original Responsible Party: Sanjib Adhikary, Milton S. Hershey Medical Center, Associate Professor, Director Acute Pain, Regional Anesthesia/Ortho
• Current Study Sponsor: Milton S. Hershey Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Milton S. Hershey Medical Center
• Verification Date: January 2023