Pain, PostoperativePhase 4NCT03961048
Ideal Initial Bolus and Infusion Rate for Erector Spinae Plane Block Catheters
A Phase 4 study testing Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution bilaterally and Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution unilaterally in people with Pain, Postoperative and Pain, Chest, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This study would like to identify the best starting dose and infusion rate for nerve blocks and nerve catheters related to the erector spinae plane block that can improve functional status and pain control on cardiac surgery patients and minimize the necessity for opioid pain control using a continuous reassessment… 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 0.2%-Sodium Chloride 0.9% Injectable Solution bilaterally and Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution unilaterally
- 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
- 23 Jul 2019to Sep 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
- patients undergoing planned thoracotomies and sternotomies for cardiothoracic surgery who will be taken to the cardiac surgery ICU postoperatively
Who cannot join
- BMI >40
- infection at the proposed catheter site
- ongoing sepsis/bacteremia
- patient unable to sit up for the procedure
- patients requiring significant vasopressor support (>1 vasopressor)
- patient refusal
- less than 18 years of age (they are managed in the pediatric ICU rather than the Cardiac Surgery ICU)
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
This study would like to identify the best starting dose and infusion rate for nerve blocks and nerve catheters related to the erector spinae plane block that can improve functional status and pain control on cardiac surgery patients and minimize the necessity for opioid pain control using a continuous reassessment model.
Read the detailed description
The study will continue taking steps in helping to identify the role erector spinae plane nerve blocks have in thoracic surgery. This is a relatively new nerve block (first identified and described in 2016) and the studies that have been done and the case series that have been reported have been very promising in supporting its role in thoracic surgery. As it is a plane block (not around a specific nerve but in a general area), larger volumes and doses often have to be used in these sorts of blocks (such as a transverses abdominalis plane block) to get good spread of the local anesthetic in the plane to reach the desired nerves that pass through this plane with one injection. Our hospital has been doing these blocks for patients as a standard of care for them, but this study will take a closer look to see if there is an optimal dose and volume of medicine to improve patients' functional status and pain control to minimize the need for opioids. The study will use a continuous reassessment model to determine the optimal dose.
- Conditions
- Pain, Postoperative, Pain, Chest
- Being tested
- Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution bilaterally, Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution unilaterally
- Keywords
- Erector Spinae, Cardiac Surgery, Regional Anesthesia
- 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 0.2%-Sodium Chloride 0.9% Injectable Solution bilaterallyDrug
Variable initial post-operative dose of 10cc to 40cc bilaterally with a variable programmed dose to be repeated afterward of 10cc to 40cc of 0.2% ropivacaine every 6 hours bilaterally.
Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution unilaterallyDrug
Variable initial post-operative dose of 10cc to 40cc unilaterally with a variable programmed dose to be repeated afterward of 10cc to 40cc of 0.2% ropivacaine every 6 hours unilaterally.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral catheters | Experimental | patients receiving bilateral catheters (such as for patients undergoing sternotomies/midline incisions or with planned bilateral thoracotomy incisions) Receives: Drug: Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution bilaterally |
| Single catheter | Experimental | patients who only have one catheter in place (such as in patients who have unilateral thoracotomies and not midline sternotomies) Receives: Drug: Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution unilaterally |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Effective Dose
Dose at which 50% of patients achieve a clinically significant nerve block after a single bolus and after periodic programmed boluses of Ropivacaine as represented by either an adequate decrease in sensation of the chest (covering at least 5 dermatomes) or an improvement in vital capacity breaths (of 500 mL or more)
Measured: 6.5 hours
Secondary outcomes (8)
Change in pain rating
Self reported pain rating on a 0-10 scale where 0 is no pain and 10 is pain as bad as it can be
Measured: From just before to 30 minutes after a bolus is administered
Change in heart rate
Heart rate measured using a heart rate monitor
Measured: From just before to 30 minutes after a bolus is administered
Blood pressure
Blood pressure measured using a blood pressure monitor
Measured: From just before to 30 minutes after a bolus is administered
Change in percent oxygen saturation of hemoglobin
Pulse oximetry reading from a monitor
Measured: From just before to 30 minutes after a bolus is administered
Changes in electrocardiogram tracing
Monitoring for changes in electrical conduction in the heart as monitored by the continuous 5 lead electrocardiogram tracing, watching for any side effects.
Measured: From just before a bolus is administered to 6.5 hours
Dermatomal coverage
The area of numbness experienced in the chest wall as measured using a pinprick test and documented on a cartoon map showing a chest wall and dermatomal borders
Measured: From just before to 30 minutes after a bolus is administered
Opioid consumption
Total opioid medication consumption during the study period
Measured: 6.5 hours
Non-narcotic pain medication consumption
Total non-narcotic pain medicine consumption during the study period
Measured: 6.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start23 Jul 2019
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Why it stopped: Change in hospital protocol
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.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- 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
- NCT03961048
- Sponsor's protocol ID
- HM20014242
- Status last verified
- Jan 2020
- First submitted
- 21 May 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- 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 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ideal Initial Bolus and Infusion Rate for Erector Spinae Plane Block Catheters
- ClinicalTrials.gov ID
- NCT03961048
- Acronym / sponsor ID
- HM20014242
- Conditions
- Pain, Postoperative, Pain, Chest
- Keywords
- Erector Spinae, Cardiac Surgery, Regional Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in hospital protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 23 May 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.
This study would like to identify the best starting dose and infusion rate for nerve blocks and nerve catheters related to the erector spinae plane block that can improve functional status and pain control on cardiac surgery patients and minimize the necessity for opioid pain control using a continuous reassessment model.
Detailed description
The study will continue taking steps in helping to identify the role erector spinae plane nerve blocks have in thoracic surgery. This is a relatively new nerve block (first identified and described in 2016) and the studies that have been done and the case series that have been reported have been very promising in supporting its role in thoracic surgery. As it is a plane block (not around a specific nerve but in a general area), larger volumes and doses often have to be used in these sorts of blocks (such as a transverses abdominalis plane block) to get good spread of the local anesthetic in the plane to reach the desired nerves that pass through this plane with one injection. Our hospital has been doing these blocks for patients as a standard of care for them, but this study will take a closer look to see if there is an optimal dose and volume of medicine to improve patients' functional status and pain control to minimize the need for opioids. The study will use a continuous reassessment model to determine the optimal dose.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral catheters | Experimental | Drug: Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution bilaterallypatients receiving bilateral catheters (such as for patients undergoing sternotomies/midline incisions or with planned bilateral thoracotomy incisions) |
| Single catheter | Experimental | Drug: Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution unilaterallypatients who only have one catheter in place (such as in patients who have unilateral thoracotomies and not midline sternotomies) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing planned thoracotomies and sternotomies for cardiothoracic surgery who will be taken to the cardiac surgery ICU postoperatively
Key exclusion criteria (7 listed)
- BMI >40
- infection at the proposed catheter site
- ongoing sepsis/bacteremia
- patient unable to sit up for the procedure
- patients requiring significant vasopressor support (>1 vasopressor)
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 0.2%-Sodium Chloride 0.9% Injectable Solution bilaterallyVariable initial post-operative dose of 10cc to 40cc bilaterally with a variable programmed dose to be repeated afterward of 10cc to 40cc of 0.2% ropivacaine every 6 hours bilaterally. | Drug | Bilateral catheters |
| Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution unilaterallyVariable initial post-operative dose of 10cc to 40cc unilaterally with a variable programmed dose to be repeated afterward of 10cc to 40cc of 0.2% ropivacaine every 6 hours unilaterally. | Drug | Single catheter |
Primary outcome
Median Effective Dose
Time frame: 6.5 hours
Dose at which 50% of patients achieve a clinically significant nerve block after a single bolus and after periodic programmed boluses of Ropivacaine as represented by either an adequate decrease in sensation of the chest (covering at least 5 dermatomes) or an improvement in vital capacity breaths (of 500 mL or more)
8 secondary outcomes
Change in pain rating
Time frame: From just before to 30 minutes after a bolus is administered
Change in heart rate
Time frame: From just before to 30 minutes after a bolus is administered
Blood pressure
Time frame: From just before to 30 minutes after a bolus is administered
Change in percent oxygen saturation of hemoglobin
Time frame: From just before to 30 minutes after a bolus is administered
Changes in electrocardiogram tracing
Time frame: From just before a bolus is administered to 6.5 hours
Dermatomal coverage
Time frame: From just before to 30 minutes after a bolus is administered
Opioid consumption
Time frame: 6.5 hours
Non-narcotic pain medication consumption
Time frame: 6.5 hours
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 27 Jan 2020.
- 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 0.2%-Sodium Chloride 0.9% Injectable Solution bilaterally and Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution unilaterally 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 1 inclusion and 7 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 27 Jan 2020. 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?
Median Effective Dose (time frame: 6.5 hours). 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 27 Jan 2020; AzTrials last refreshed its copy on 26 Oct 2026.