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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03476642

Enrollment

Registered

2018-03-26

Start date

2019-07-02

Completion date

2024-03-31

Last updated

2025-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distribution of Ropivacaine in Erector Spinae Plane Block

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.

Interventions

DRUGRopivacaine

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

DRUGEpinephrine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

This will be a randomized,double blinded, controlled study.

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Area of Dermatomal Sensory Loss at 20 Min	20 minutes from the time of the ESP block	A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin
Area of Dermatomal Sensory Loss 60 Min	60 minutes from the time of the ESP block	A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin
Area of Dermatomal Sensory Loss 120 Min	120 minutes from the time of the ESP block	A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin
Area of Dermatomal Sensory Loss at 240 Min	240 minutes from the time of the ESP block	A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin
Area of Dermatomal Sensory Loss 360 Min	360 minutes from the time of the ESP block	A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin
Venous Plasma Concentration of Ropivacaine at 20 Min	These samples will be repeated at 20 minutes after completion of the injection of active drug.	3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.
Venous Plasma Concentration of Ropivacaine at 60 Min	These samples will be repeated at 60 minutes after completion of the injection of active drug.	3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.
Venous Plasma Concentration of Ropivacaine at 90 Min	These samples will be repeated at 90 minutes after completion of the injection of active drug.	3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.
Venous Plasma Concentration of Ropivacaine at 120 Min	These samples will be repeated at 120 after completion of the injection of active drug.	3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.
Venous Plasma Concentration of Ropivacaine at 240 Min	These samples will be repeated at 240 minutes after completion of the injection of active drug.	3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.
Volume of Injectate Spread Measured Using MRI at 30 Min	30 minutes from the time of the ESP block	The subject will undergo two MRIs to determine the spread of the anesthetic.
Volume of Injectate Spread Measured Using MRI at 90 Min	90 minutes from the time of the ESP block	The subject will undergo two MRIs to determine the spread of the anesthetic.

Countries

United States

Participant flow

Participants by arm

Arm	Count
0.5% Ropivacaine With Epinephrine 20mL of 0.5% Ropivacaine with epinephrine injected at the left or right T5 transverse process.	6
0.5% Ropivacaine Without Epinephrine 0.5% Ropivacaine without epinephrine injected at the left or right T5 transverse process.	6
Total	12

Baseline characteristics

Characteristic	0.5% Ropivacaine Without Epinephrine	Total	0.5% Ropivacaine With Epinephrine
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	6 Participants	12 Participants	6 Participants
Age, Continuous	31 years	37 years	42 years
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment United States	6 participants	12 participants	6 participants
Sex: Female, Male Female	4 Participants	7 Participants	3 Participants
Sex: Female, Male Male	2 Participants	5 Participants	3 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 6	0 / 6
other Total, other adverse events	0 / 6	0 / 6
serious Total, serious adverse events	0 / 6	0 / 6