NCT03476642

Distribution, Pharmacokinetics and Extent of Sensory Blockade in ESP Blocks

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2019-07-02
• Primary completion: 2024-02-19
• Completion: 2024-03-31
• First posted: 2018-03-26
• Last updated: 2025-05-02
• Results posted: 2025-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study