Distribution, Pharmacokinetics and Extent of Sensory Blockade in ESP Blocks

NCT03476642 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: STUDY0008641
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Distribution of Ropivacaine in Erector Spinae Plane Block

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (2)

Ropivacaine with Epinephrine

ACTIVE COMPARATOR

Group RE will have 20mL of 0.5% Ropivacaine with epinephrine injected at the left or right T5 transverse process.

Drug: Ropivacaine; Drug: Epinephrine

Ropivacaine without Epinephrine

ACTIVE COMPARATOR

Group R will have 20mL of 0.5% Ropivacaine without epinephrine injected at the left or right T5 transverse process.

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

injection of 20mL of 0.5% Ropivacaine at the left or right T5 transverse process

Ropivacaine with Epinephrine; Ropivacaine without Epinephrine

Epinephrine DRUG

injection of 20mL epinephrine in combination with ropivacaine at the left or right T5 transverse process

Ropivacaine with Epinephrine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults aged 18 to 60 inclusive
• Weight between 60 and 100 kg inclusive
• Height 160 to190 cm inclusive

You may not qualify if:

• 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.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Milton S.Hershey Medical center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Interventions

Ropivacaine; Epinephrine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Dr. Sanjib Adhikary
• Organization: Penn State MS Hershey College of Medicine-PennState Health

sadhikary@pennstatehealth.psu.edu

717-531-6140

Study Officials

• Sanjib Adhikary, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Director Acute Pain, Regional Anesthesia/Ortho

Model Details: This will be a randomized,double blinded, controlled study.

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 26, 2018
• Study Start: July 2, 2019
• Primary Completion: February 19, 2024
• Study Completion: March 31, 2024
• Last Updated: May 2, 2025
• Results First Posted: March 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)