Mitral Valve InsufficiencyPhase 4NCT02180893
The Use of Paravertebral Block for Cardiac Surgery
A Phase 4 study testing Paravertebral Block in people with Mitral Valve Insufficiency, run by NYU Langone Health at 1 site in United States.
Trial summary
Pain after robotic cardiac surgery is a known problem and is often difficult to manage. Paravertebral nerve blocks are a proven method of pain relief following thoracotomy. A paravertebral block has been shown to provide good pain relief with minimal side effects, however, paravertebral blocks for robotic surgery have… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Mitral Valve Insufficiency
- What is being tested?
- Paravertebral Block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Apr 2014
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over the age of 18 years of age undergoing robotic mitral valve surgery.
- have capacity to understand and sign consent form
Who cannot join
- patients that are not candidates for paravertebral block as per ASRA guidelines (Horlocker, Reg Anesth Pain Med, 2010). In short, this includes patients taking specific anti platelet agents such as clopidigrel, anticoagulants such as heparin or low molecular weight heparin, or patients with an INR of greater than 1.5. -patients with a history of COPD or other respiratory diseases that would confound data on time to extubated will be excluded.
- Patients that with a diagnosis of chronic pain, or patients currently taking narcotics are excluded, as this would confound data on postoperative narcotic requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Medical Center
New York, New York, 10016
About this study
Official title: Study of Paravertebral Block for Cardiac Surgery
Pain after robotic cardiac surgery is a known problem and is often difficult to manage. Paravertebral nerve blocks are a proven method of pain relief following thoracotomy. A paravertebral block has been shown to provide good pain relief with minimal side effects, however, paravertebral blocks for robotic surgery have not been well studied. Currently the investigators routinely perform PVB on this patient population (of 50 MV robotic cases done between January and October 2012, 36 received paravertebral blocks with no adverse events noted). The investigators believe this should be studied further and that paravertebral blocks will reduce the amount of additional pain medication patients require in the first 24 hours after surgery, decrease intubation time and improve PACU and hospital discharge times.
Read the detailed description
Pain after robotic cardiac surgery is a known problem and is often difficult to manage. Paravertebral nerve blocks are a proven method of pain relief following thoracotomy. A paravertebral block has been shown to provide good pain relief with minimal side effects, however, paravertebral blocks for robotic surgery have not been well studied. Currently we routinely perform PVB on this patient population (of 50 MV robotic cases done between January and October 2012, 36 received paravertebral blocks with no adverse events noted). We believe this should be studied further and that paravertebral blocks will reduce the amount of additional pain medication patients require in the first 24 hours after surgery, decrease intubation time and improve PACU and hospital discharge times.
- Conditions
- Mitral Valve Insufficiency
- Being tested
- Paravertebral Block, Placebo Comparator
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paravertebral BlockOther
Paravertebral nerve block injection
Placebo ComparatorOther
No block
Patients who did not receive PVB
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral block | Experimental | Patient receiving a PVB prior to robotic mitral valve surgery Receives: Other: Paravertebral Block |
| No block | Placebo comparator | Patients who did not receive PVB Receives: Other: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Fentanyl
Measured: 24 hours
Visual Analog Scale (VAS) Pain Scores
Possible scores range from 0-10, with 0 being no pain and 10 being highest level of pain
Measured: 24 hours
Secondary outcomes (2)
Participant Satisfaction
Participants were asked whether or not they were satisfied with their postoperative pain control (yes or no)
Measured: 48 hours
Participant Satisfaction Score
Participants were asked to score their satisfaction with their postoperative pain control on a scale of 0 (least satisfied) to 10 (most satisfied)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startJan 2013
- Primary completionApr 2014
- Study completionApr 2014
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter J Neuburger, MD, Principal investigator, NYU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180893
- Sponsor's protocol ID
- S12-02774
- Status last verified
- Feb 2016
- First submitted
- 1 Jul 2014
- Last updated
- 15 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Suri RM, Antiel RM, Burkhart HM, Huebner M, Li Z, Eton DT, Topilsky T, Sarano ME, Schaff HV. Quality of life after early mitral valve repair using conventional and robotic approaches. Ann Thorac Surg. 2012 Mar;93(3):761-9. doi: 10.1016/j.athoracsur.2011.11.062.
PubMed 22364970Lynch JJ, Mauermann WJ, Pulido JN, Rehfeldt KH, Torres NE. Use of paravertebral blockade to facilitate early extubation after minimally invasive cardiac surgery. Semin Cardiothorac Vasc Anesth. 2010 Mar;14(1):47-8. doi: 10.1177/1089253210363009.
PubMed 20472625
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Paravertebral Block for Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02180893
- Acronym / sponsor ID
- S12-02774
- Conditions
- Mitral Valve Insufficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 3 Jul 2014 (estimated)
- Results
- Posted 15 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pain after robotic cardiac surgery is a known problem and is often difficult to manage. Paravertebral nerve blocks are a proven method of pain relief following thoracotomy. A paravertebral block has been shown to provide good pain relief with minimal side effects, however, paravertebral blocks for robotic surgery have not been well studied. Currently the investigators routinely perform PVB on this patient population (of 50 MV robotic cases done between January and October 2012, 36 received paravertebral blocks with no adverse events noted). The investigators believe this should be studied further and that paravertebral blocks will reduce the amount of additional pain medication patients require in the first 24 hours after surgery, decrease intubation time and improve PACU and hospital discharge times.
Detailed description
Pain after robotic cardiac surgery is a known problem and is often difficult to manage. Paravertebral nerve blocks are a proven method of pain relief following thoracotomy. A paravertebral block has been shown to provide good pain relief with minimal side effects, however, paravertebral blocks for robotic surgery have not been well studied. Currently we routinely perform PVB on this patient population (of 50 MV robotic cases done between January and October 2012, 36 received paravertebral blocks with no adverse events noted). We believe this should be studied further and that paravertebral blocks will reduce the amount of additional pain medication patients require in the first 24 hours after surgery, decrease intubation time and improve PACU and hospital discharge times.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paravertebral block | Experimental | Other: Paravertebral BlockPatient receiving a PVB prior to robotic mitral valve surgery |
| No block | Placebo comparator | Other: Placebo ComparatorPatients who did not receive PVB |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients over the age of 18 years of age undergoing robotic mitral valve surgery.
- have capacity to understand and sign consent form
Key exclusion criteria (2 listed)
- patients that are not candidates for paravertebral block as per ASRA guidelines (Horlocker, Reg Anesth Pain Med, 2010). In short, this includes patients taking specific anti platelet agents such as clopidigrel, anticoagulants such as heparin or low molecular weight heparin, or patients with an INR of greater than 1.5. -patients with a history of COPD or other respiratory diseases that would confound data on time to extubated will be excluded.
- Patients that with a diagnosis of chronic pain, or patients currently taking narcotics are excluded, as this would confound data on postoperative narcotic requirements.
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 |
|---|---|---|
| Paravertebral BlockParavertebral nerve block injection | Other | Paravertebral block |
| Placebo ComparatorNo block Patients who did not receive PVB | Other | No block |
Primary outcome
Postoperative Fentanyl
Time frame: 24 hours
Visual Analog Scale (VAS) Pain Scores
Time frame: 24 hours
Possible scores range from 0-10, with 0 being no pain and 10 being highest level of pain
2 secondary outcomes
Participant Satisfaction
Time frame: 48 hours
Participant Satisfaction Score
Time frame: 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22364970Suri RM, Antiel RM, Burkhart HM, Huebner M, Li Z, Eton DT, Topilsky T, Sarano ME, Schaff HV. Quality of life after early mitral valve repair using conventional and robotic approaches. Ann Thorac Surg. 2012 Mar;93(3):761-9. doi: 10.1016/j.athoracsur.2011.11.062.
- Background: PubMed 20472625Lynch JJ, Mauermann WJ, Pulido JN, Rehfeldt KH, Torres NE. Use of paravertebral blockade to facilitate early extubation after minimally invasive cardiac surgery. Semin Cardiothorac Vasc Anesth. 2010 Mar;14(1):47-8. doi: 10.1177/1089253210363009.
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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.
Peter J Neuburger, MD principal investigator
NYU
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 Paravertebral Block in people with Mitral Valve Insufficiency, run by NYU Langone Health 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 2 inclusion and 2 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 15 Mar 2016. 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. Some participants in this study may receive a placebo. 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 15 Mar 2016). 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?
Postoperative Fentanyl (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02180893, which also lists 2 linked publications.
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 Mar 2016.