Distribution of Ropivacaine in Erector Spinae Plane BlockPhase 4NCT03476642
Distribution, Pharmacokinetics and Extent of Sensory Blockade in ESP Blocks
A Phase 4 study testing Ropivacaine and Epinephrine in people with Distribution of Ropivacaine in Erector Spinae Plane Block, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Distribution of Ropivacaine in Erector Spinae Plane Block
- What is being tested?
- Ropivacaine and Epinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2019to 31 Mar 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 18 to 60 inclusive
- Weight between 60 and 100 kg inclusive
- Height 160 to190 cm inclusive
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Milton S.Hershey Medical center
Hershey, Pennsylvania, 17033
About this study
Official title: 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.
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.
- Being tested
- Ropivacaine, Epinephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
injection of 20mL of 0.5% Ropivacaine at the left or right T5 transverse process
EpinephrineDrug
injection of 20mL epinephrine in combination with ropivacaine at the left or right T5 transverse process
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine with Epinephrine | Active comparator | Group RE will have 20mL of 0.5% Ropivacaine with epinephrine injected at the left or right T5 transverse process. Receives: Drug: Ropivacaine; Drug: Epinephrine |
| Ropivacaine without Epinephrine | Active comparator | Group R will have 20mL of 0.5% Ropivacaine without epinephrine injected at the left or right T5 transverse process. Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 20 minutes from the time of the ESP block
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
Measured: 60 minutes from the time of the ESP block
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
Measured: 120 minutes from the time of the ESP block
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
Measured: 240 minutes from the time of the ESP block
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
Measured: 360 minutes from the time of the ESP block
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.
Measured: These samples will be repeated at 20 minutes after completion of the injection of active drug.
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.
Measured: These samples will be repeated at 60 minutes after completion of the injection of active drug.
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.
Measured: These samples will be repeated at 90 minutes after completion of the injection of active drug.
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.
Measured: These samples will be repeated at 120 after completion of the injection of active drug.
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.
Measured: These samples will be repeated at 240 minutes after completion of the injection of active drug.
Volume of Injectate Spread Measured Using MRI at 30 Min
The subject will undergo two MRIs to determine the spread of the anesthetic.
Measured: 30 minutes from the time of the ESP block
Volume of Injectate Spread Measured Using MRI at 90 Min
The subject will undergo two MRIs to determine the spread of the anesthetic.
Measured: 90 minutes from the time of the ESP block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start2 Jul 2019
- Primary completion19 Feb 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Distribution of Ropivacaine in Erector Spinae Plane BlockStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a randomized,double blinded, controlled study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjib D Adhikary, Milton S. Hershey Medical Center
- Investigators
- Sanjib Adhikary, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476642
- Sponsor's protocol ID
- STUDY0008641
- Status last verified
- Apr 2025
- First submitted
- 1 Mar 2018
- Last updated
- 2 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03476642
- Acronym / sponsor ID
- STUDY0008641
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 2 Jul 2019 (actual)
- Primary completion
- 19 Feb 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Posted 13 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a randomized,double blinded, controlled study.
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine with Epinephrine | Active comparator | Drug: Ropivacaine, Drug: EpinephrineGroup RE will have 20mL of 0.5% Ropivacaine with epinephrine injected at the left or right T5 transverse process. |
| Ropivacaine without Epinephrine | Active comparator | Drug: RopivacaineGroup R will have 20mL of 0.5% Ropivacaine without epinephrine injected at the left or right T5 transverse process. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults aged 18 to 60 inclusive
- Weight between 60 and 100 kg inclusive
- Height 160 to190 cm inclusive
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaineinjection of 20mL of 0.5% Ropivacaine at the left or right T5 transverse process | Drug | Ropivacaine with Epinephrine, Ropivacaine without Epinephrine |
| Epinephrineinjection of 20mL epinephrine in combination with ropivacaine at the left or right T5 transverse process | Drug | Ropivacaine with Epinephrine |
Primary outcome
Area of Dermatomal Sensory Loss at 20 Min
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 90 minutes from the time of the ESP block
The subject will undergo two MRIs to determine the spread of the anesthetic.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjib Adhikary, MD principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine and Epinephrine in people with Distribution of Ropivacaine in Erector Spinae Plane Block, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area of Dermatomal Sensory Loss at 20 Min (time frame: 20 minutes from the time of the ESP block). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.