Distribution, Pharmacokinetics and Extent of Sensory Blockade in ESP Blocks

Penn State Health

Status and phase: Completed; Phase 4

Conditions: Distribution of Ropivacaine in Erector Spinae Plane Block

Treatments: Drug: Epinephrine; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03476642

STUDY0008641

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

12 participants in 2 patient groups

Ropivacaine with Epinephrine

Active Comparator group

Description:

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

Treatment:

Drug: Epinephrine

Drug: Ropivacaine

Ropivacaine without Epinephrine

Active Comparator group

Description:

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

Treatment:

Drug: Ropivacaine