CClinicalTrials.gg
Sign In
CompletedNCT03476642Updated May 2, 2025Results posted

Distribution, Pharmacokinetics and Extent of Sensory Blockade in ESP Blocks

A Phase 4 interventional study of Ropivacaine and Epinephrine in Distribution of Ropivacaine in Erector Spinae Plane Block, sponsored by Milton S. Hershey Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-02.

Sponsored by Milton S. Hershey Medical Center · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Distribution of Ropivacaine in Erector Spinae Plane Block
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts 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

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.
04

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
12 participants (actual)

Study arms

  • Active comparator
    Ropivacaine with Epinephrine

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

    Drug: Ropivacaine · Drug: Epinephrine

  • Active comparator
    Ropivacaine without Epinephrine

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

    Drug: Ropivacaine

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

05

What researchers measure

Primary outcomes

  1. Area of Dermatomal Sensory Loss at 20 Min

    A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin

    Time frame: 20 minutes from the time of the ESP block

  2. Area of Dermatomal Sensory Loss 60 Min

    A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin

    Time frame: 60 minutes from the time of the ESP block

  3. Area of Dermatomal Sensory Loss 120 Min

    A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin

    Time frame: 120 minutes from the time of the ESP block

  4. Area of Dermatomal Sensory Loss at 240 Min

    A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin

    Time frame: 240 minutes from the time of the ESP block

  5. Area of Dermatomal Sensory Loss 360 Min

    A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin

    Time frame: 360 minutes from the time of the ESP block

  6. Venous Plasma Concentration of Ropivacaine at 20 Min

    3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.

    Time frame: These samples will be repeated at 20 minutes after completion of the injection of active drug.

  7. Venous Plasma Concentration of Ropivacaine at 60 Min

    3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.

    Time frame: These samples will be repeated at 60 minutes after completion of the injection of active drug.

  8. Venous Plasma Concentration of Ropivacaine at 90 Min

    3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.

    Time frame: These samples will be repeated at 90 minutes after completion of the injection of active drug.

  9. Venous Plasma Concentration of Ropivacaine at 120 Min

    3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.

    Time frame: These samples will be repeated at 120 after completion of the injection of active drug.

  10. Venous Plasma Concentration of Ropivacaine at 240 Min

    3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.

    Time frame: These samples will be repeated at 240 minutes after completion of the injection of active drug.

  11. Volume of Injectate Spread Measured Using MRI at 30 Min

    The subject will undergo two MRIs to determine the spread of the anesthetic.

    Time frame: 30 minutes from the time of the ESP block

  12. Volume of Injectate Spread Measured Using MRI at 90 Min

    The subject will undergo two MRIs to determine the spread of the anesthetic.

    Time frame: 90 minutes from the time of the ESP block

06

Results

Posted Mar 13, 2025

Participant flow

Participant flow — Overall Study
Milestone0.5% Ropivacaine With Epinephrine0.5% Ropivacaine Without Epinephrine
Started66
Completed66
Not completed00

Outcome measures

PrimaryArea of Dermatomal Sensory Loss at 20 Min

A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin

Time frame:
20 minutes from the time of the ESP block
Reported as:
Mean · cm^2
Area of Dermatomal Sensory Loss at 20 Min
cm^20.5% Ropivacaine With Epinephrine0.5% Ropivacaine Without Epinephrine
Area of Dermatomal Sensory Loss at 20 Min68.8 ± 43.7167.5 ± 178.0
PrimaryArea of Dermatomal Sensory Loss 60 Min

A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin

Time frame:
60 minutes from the time of the ESP block
Reported as:
Mean · cm^2
Area of Dermatomal Sensory Loss 60 Min
cm^20.5% Ropivacaine With Epinephrine0.5% Ropivacaine Without Epinephrine
Area of Dermatomal Sensory Loss 60 Min90.2 ± 43.961.0 ± 37.1
PrimaryArea of Dermatomal Sensory Loss 120 Min

A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin

Time frame:
120 minutes from the time of the ESP block
Reported as:
Mean · cm^2
Area of Dermatomal Sensory Loss 120 Min
cm^20.5% Ropivacaine With Epinephrine0.5% Ropivacaine Without Epinephrine
Area of Dermatomal Sensory Loss 120 Min107.1 ± 69.8109.1 ± 125.0
PrimaryArea of Dermatomal Sensory Loss at 240 Min

A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin

Time frame:
240 minutes from the time of the ESP block
Reported as:
Mean · cm^2
Area of Dermatomal Sensory Loss at 240 Min
cm^20.5% Ropivacaine With Epinephrine0.5% Ropivacaine Without Epinephrine
Area of Dermatomal Sensory Loss at 240 Min55.5 ± 36.0114.5 ± 170.8
PrimaryArea of Dermatomal Sensory Loss 360 Min

A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin

Time frame:
360 minutes from the time of the ESP block
Reported as:
Mean · cm^2
Area of Dermatomal Sensory Loss 360 Min
cm^20.5% Ropivacaine With Epinephrine0.5% Ropivacaine Without Epinephrine
Area of Dermatomal Sensory Loss 360 Min35.0 ± 46.112.9 ± 24.3
PrimaryVenous Plasma Concentration of Ropivacaine at 20 Min

3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.

Time frame:
These samples will be repeated at 20 minutes after completion of the injection of active drug.
Reported as:
Mean · ng/mL
Venous Plasma Concentration of Ropivacaine at 20 Min
ng/mL0.5% Ropivacaine With Epinephrine0.5% Ropivacaine Without Epinephrine
Venous Plasma Concentration of Ropivacaine at 20 Min599.6 ± 187.21284.7 ± 336.5
PrimaryVenous Plasma Concentration of Ropivacaine at 60 Min

3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.

Time frame:
These samples will be repeated at 60 minutes after completion of the injection of active drug.
Reported as:
Mean · ng/mL
Venous Plasma Concentration of Ropivacaine at 60 Min
ng/mL0.5% Ropivacaine With Epinephrine0.5% Ropivacaine Without Epinephrine
Venous Plasma Concentration of Ropivacaine at 60 Min669.0 ± 114.4962.4 ± 365.3
PrimaryVenous Plasma Concentration of Ropivacaine at 90 Min

3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.

Time frame:
These samples will be repeated at 90 minutes after completion of the injection of active drug.
Reported as:
Mean · ng/mL
Venous Plasma Concentration of Ropivacaine at 90 Min
ng/mL0.5% Ropivacaine With Epinephrine0.5% Ropivacaine Without Epinephrine
Venous Plasma Concentration of Ropivacaine at 90 Min625.9 ± 171.9837.9 ± 349.3
PrimaryVenous Plasma Concentration of Ropivacaine at 120 Min

3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.

Time frame:
These samples will be repeated at 120 after completion of the injection of active drug.
Reported as:
Mean · ng/mL
Venous Plasma Concentration of Ropivacaine at 120 Min
ng/mL0.5% Ropivacaine With Epinephrine0.5% Ropivacaine Without Epinephrine
Venous Plasma Concentration of Ropivacaine at 120 Min640.0 ± 129.5691.6 ± 289.9
PrimaryVenous Plasma Concentration of Ropivacaine at 240 Min

3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.

Time frame:
These samples will be repeated at 240 minutes after completion of the injection of active drug.
Reported as:
Mean · ng/mL
Venous Plasma Concentration of Ropivacaine at 240 Min
ng/mL0.5% Ropivacaine With Epinephrine0.5% Ropivacaine Without Epinephrine
Venous Plasma Concentration of Ropivacaine at 240 Min480.3 ± 99.0420.9 ± 183.5
PrimaryVolume of Injectate Spread Measured Using MRI at 30 Min

The subject will undergo two MRIs to determine the spread of the anesthetic.

Time frame:
30 minutes from the time of the ESP block
Reported as:
Mean · mm^3
Volume of Injectate Spread Measured Using MRI at 30 Min
mm^30.5% Ropivacaine With Epinephrine0.5% Ropivacaine Without Epinephrine
Volume of Injectate Spread Measured Using MRI at 30 Min4373.2 ± 1013.53712.8 ± 1011.3
PrimaryVolume of Injectate Spread Measured Using MRI at 90 Min

The subject will undergo two MRIs to determine the spread of the anesthetic.

Time frame:
90 minutes from the time of the ESP block
Reported as:
Mean · mm^3
Volume of Injectate Spread Measured Using MRI at 90 Min
mm^30.5% Ropivacaine With Epinephrine0.5% Ropivacaine Without Epinephrine
Volume of Injectate Spread Measured Using MRI at 90 Min3863.0 ± 944.63751.2 ± 1197.2

Adverse events

Collected over up to 48 hour following intervention. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group With EPI0/6 (0%)0/6 (0%)0/6 (0%)
Group Without Epi0/6 (0%)0/6 (0%)0/6 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)0.5% Ropivacaine With Epinephrine0.5% Ropivacaine Without EpinephrineTotal
<=18 years000
Between 18 and 65 years6612
>=65 years000
Age, Continuous
Age, Continuous(years)0.5% Ropivacaine With Epinephrine0.5% Ropivacaine Without EpinephrineTotal
Mean42 (25 to 59)31 (23 to 54)37 (23 to 59)
Sex: Female, Male
Sex: Female, Male(Participants)0.5% Ropivacaine With Epinephrine0.5% Ropivacaine Without EpinephrineTotal
Female347
Male325
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)0.5% Ropivacaine With Epinephrine0.5% Ropivacaine Without EpinephrineTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)0.5% Ropivacaine With Epinephrine0.5% Ropivacaine Without EpinephrineTotal
United States6612
07

Study locations

1 site
  • Milton S.Hershey Medical center
    Hershey, Pennsylvania 17033, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 23, 2024
  • Informed consent form · Sep 25, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03476642
Lead sponsor
Milton S. Hershey Medical Center
Responsible party
Sanjib D Adhikary (Associate Professor, Director Acute Pain, Regional Anesthesia/Ortho, Milton S. Hershey Medical Center) — Principal investigator
First posted
Mar 26, 2018
Start date
Jul 2, 2019
Primary completion
Feb 19, 2024
Completion
Mar 31, 2024
Results posted
Mar 13, 2025
Last update
May 2, 2025

Study contacts

Sanjib Adhikary, MD
principal investigator · Milton S. Hershey Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Milton S. Hershey Medical Center

Start the discussion