Phase 4 N=12 Randomized Quadruple-blind Basic Science

Distribution, Pharmacokinetics and Extent of Sensory Blockade in ESP Blocks

Distribution of Ropivacaine in Erector Spinae Plane Block

Bottom Line

View on ClinicalTrials.gov: NCT03476642 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcome: Primary: Area of Dermatomal Sensory Loss at 20 Min — 68.8; 167.5 cm^2

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ropivacaine (Drug); Epinephrine (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Milton S. Hershey Medical Center
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Area of Dermatomal Sensory Loss at 20 Min	68.8; 167.5	—
PRIMARY Area of Dermatomal Sensory Loss 60 Min	90.2; 61.0	—
PRIMARY Area of Dermatomal Sensory Loss 120 Min	107.1; 109.1	—
PRIMARY Area of Dermatomal Sensory Loss at 240 Min	55.5; 114.5	—
PRIMARY Area of Dermatomal Sensory Loss 360 Min	35.0; 12.9	—
PRIMARY Venous Plasma Concentration of Ropivacaine at 20 Min	599.6; 1284.7	—
PRIMARY Venous Plasma Concentration of Ropivacaine at 60 Min	669.0; 962.4	—
PRIMARY Venous Plasma Concentration of Ropivacaine at 90 Min	625.9; 837.9	—
PRIMARY Venous Plasma Concentration of Ropivacaine at 120 Min	640.0; 691.6	—
PRIMARY Venous Plasma Concentration of Ropivacaine at 240 Min	480.3; 420.9	—
PRIMARY Volume of Injectate Spread Measured Using MRI at 30 Min	4373.2; 3712.8	—
PRIMARY Volume of Injectate Spread Measured Using MRI at 90 Min	3863.0; 3751.2	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03476642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.