Pain, PostoperativePhase 4NCT03874806
Pharmacokinetic Profile and Dermatomal Coverage of the Erector Spinae Plane Block
A Phase 4 study testing Ropivacaine 0.25%-NaCl 0.9% Injectable Solution and Ropivacaine 0.2%-NaCl 0.9% Injectable Solution in people with Pain, Postoperative and Pain, Chest, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The goals of this study are as follows: 1. to confirm the safe dosing of ropivacaine for the erector spinae plane block 2. develop a pharmacokinetic profile of the erector spinae plane block, which will help demonstrate how quickly and how closely toxic levels are reached when a routine dose of ropivacaine is given… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Pain, Chest
- What is being tested?
- Ropivacaine 0.25%-NaCl 0.9% Injectable Solution and Ropivacaine 0.2%-NaCl 0.9% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 31 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant's age is greater than 18 years
- Participant is undergoing a primary coronary artery bypass grafting surgery or heart valve replacement that requires a midline sternotomy incision
- Participant's surgery is being performed by Dr. Vig Kasirajan
Who cannot join
- Diagnosis of cirrhosis, hepatitis, primary sclerosing cholangitis
- Abnormal liver function tests demonstrated by lab results
- Allergy to lidocaine, ropivacaine, or midazolam
- Morbid obesity, defined as body mass index greater than 40
- Existing skin neuropathy on the chest or back
- Body weight less than 50 kg
Show all 9Show fewer
- Participant is not able to provide verbal feedback, such as when the participant develops altered mental status or requires prolonged mechanical ventilation and sedation
- Participant remains intubated on post-operative day 1
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Pharmacokinetic Profile and Dermatomal Coverage of the Erector Spinae Plane Block: a Comparison of Bolus Dosing and Continuous Infusion
The goals of this study are as follows:
- to confirm the safe dosing of ropivacaine for the erector spinae plane block
- develop a pharmacokinetic profile of the erector spinae plane block, which will help demonstrate how quickly and how closely toxic levels are reached when a routine dose of ropivacaine is given for this nerve block
- assess numbness created by the erector spinae block when routine doses are administered
- Conditions
- Pain, Postoperative, Pain, Chest
- Being tested
- Ropivacaine 0.25%-NaCl 0.9% Injectable Solution, Ropivacaine 0.2%-NaCl 0.9% Injectable Solution
- Medical subject headings
- Pain, Postoperative, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.25%-NaCl 0.9% Injectable SolutionDrug
0.25% ropivacaine administered through a nerve catheter
Ropivacaine 0.2%-NaCl 0.9% Injectable SolutionDrug
0.2% ropivacaine administered through a nerve catheter
| Study group | Role | What they receive |
|---|---|---|
| single | Experimental | local anesthetic is delivered as a single bolus Receives: Drug: Ropivacaine 0.25%-NaCl 0.9% Injectable Solution |
| continuous | Active comparator | local anesthetic is delivered as a continuous infusion Receives: Drug: Ropivacaine 0.2%-NaCl 0.9% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
The maximum concentration of serum ropivacaine after pre-determined dose is delivered through the ESP nerve catheter
Measured: 28 hours
Tmax
The time elapsed from initial ropivacaine administration to Cmax
Measured: 28 hours
Area of analgesia
The area of numbness experienced in the chest wall; measured using a pinprick test and documented on a cartoon map showing a chest wall and dermatomal borders
Measured: 4 hours
Duration of analgesia
The duration of numbness to the chest wall; start time will be when the local anesthetic bolus is given, and end time will be when the participant reports the resolution of chest wall numbness
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start1 Jul 2019 (estimated)
- Primary completion1 Jul 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Why it stopped: Did not receive funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bryant Tran, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874806
- Sponsor's protocol ID
- HM20014803
- Status last verified
- Jul 2019
- First submitted
- 8 Mar 2019
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Profile and Dermatomal Coverage of the Erector Spinae Plane Block: a Comparison of Bolus Dosing and Continuous Infusion
- ClinicalTrials.gov ID
- NCT03874806
- Acronym / sponsor ID
- HM20014803
- Conditions
- Pain, Postoperative, Pain, Chest
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not receive funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 14 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goals of this study are as follows:
- to confirm the safe dosing of ropivacaine for the erector spinae plane block
- develop a pharmacokinetic profile of the erector spinae plane block, which will help demonstrate how quickly and how closely toxic levels are reached when a routine dose of ropivacaine is given for this nerve block
- assess numbness created by the erector spinae block when routine doses are administered
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single | Experimental | Drug: Ropivacaine 0.25%-NaCl 0.9% Injectable Solutionlocal anesthetic is delivered as a single bolus |
| continuous | Active comparator | Drug: Ropivacaine 0.2%-NaCl 0.9% Injectable Solutionlocal anesthetic is delivered as a continuous infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant's age is greater than 18 years
- Participant is undergoing a primary coronary artery bypass grafting surgery or heart valve replacement that requires a midline sternotomy incision
- Participant's surgery is being performed by Dr. Vig Kasirajan
Key exclusion criteria (9 listed)
- Diagnosis of cirrhosis, hepatitis, primary sclerosing cholangitis
- Abnormal liver function tests demonstrated by lab results
- Allergy to lidocaine, ropivacaine, or midazolam
- Morbid obesity, defined as body mass index greater than 40
- Existing skin neuropathy on the chest or back
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 |
|---|---|---|
| Ropivacaine 0.25%-NaCl 0.9% Injectable Solution0.25% ropivacaine administered through a nerve catheter | Drug | single |
| Ropivacaine 0.2%-NaCl 0.9% Injectable Solution0.2% ropivacaine administered through a nerve catheter | Drug | continuous |
Primary outcome
Cmax
Time frame: 28 hours
The maximum concentration of serum ropivacaine after pre-determined dose is delivered through the ESP nerve catheter
Tmax
Time frame: 28 hours
The time elapsed from initial ropivacaine administration to Cmax
Area of analgesia
Time frame: 4 hours
The area of numbness experienced in the chest wall; measured using a pinprick test and documented on a cartoon map showing a chest wall and dermatomal borders
Duration of analgesia
Time frame: 4 hours
The duration of numbness to the chest wall; start time will be when the local anesthetic bolus is given, and end time will be when the participant reports the resolution of chest wall numbness
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Bryant Tran, MD principal investigator
Virginia Commonwealth University
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 0.25%-NaCl 0.9% Injectable Solution and Ropivacaine 0.2%-NaCl 0.9% Injectable Solution in people with Pain, Postoperative and Pain, Chest, run by Virginia Commonwealth University 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: withdrawn, as of the sponsor's last update on 15 Jul 2019. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Cmax (time frame: 28 hours). The study lists 4 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 15 Jul 2019.