Distribution, Pharmacokinetics and Extent of Sensory Blockade in ESP Blocks

NCT03476642 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-05-02

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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

Interventions

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

Sponsors & Collaborators

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • Sanjib Adhikary, MD · Milton S. Hershey Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-02
Primary Completion
2024-02-19
Completion
2024-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03476642 on ClinicalTrials.gov