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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paravertebral block | Experimental | Patient receiving a PVB prior to robotic mitral valve surgery |
|
| No block | Placebo Comparator | Patients who did not receive PVB |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paravertebral Block | Other | Paravertebral nerve block injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Fentanyl | 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 | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Satisfaction | Participants were asked whether or not they were satisfied with their postoperative pain control (yes or no) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter J Neuburger, MD | NYU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22364970 | Background | 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. | |
| 20472625 | Background | Lynch 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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| ID | Title | Description |
|---|---|---|
| FG000 | Paravertebral Block | Patient receiving a PVB prior to robotic mitral valce surgery Paravertebral Block: Paravertebral nerve block injection |
| FG001 | No Block | Patients who did not receive PVB Placebo Comparator: No block Patients who did not receive PVB |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Paravertebral Block | Patient receiving a PVB prior to robotic mitral valce surgery Paravertebral Block: Paravertebral nerve block injection |
| BG001 | No Block | Patients who did not receive PVB Placebo Comparator: No block Patients who did not receive PVB |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postoperative Fentanyl | Posted | Mean | Standard Deviation | microgram/kilogram | 24 hours |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paravertebral Block | Patient receiving a PVB prior to robotic mitral valce surgery Paravertebral Block: Paravertebral nerve block injection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Neuberger | NYU Langone Medical Center | 212 263 5821 | Peter.Neuburger@nyumc.org |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Placebo Comparator |
| Other |
No block Patients who did not receive PVB |
|
| 48 hours |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Visual Analog Scale (VAS) Pain Scores | Possible scores range from 0-10, with 0 being no pain and 10 being highest level of pain | Posted | Mean | Standard Deviation | units on a scale | 24 hours |
|
|
|
| Secondary | Participant Satisfaction | Participants were asked whether or not they were satisfied with their postoperative pain control (yes or no) | Posted | Number | percentage of "yes" responders | 48 hours |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | units on a scale | 48 hours |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | No Block | Patients who did not receive PVB Placebo Comparator: No block Patients who did not receive PVB | 0 | 30 | 0 | 30 |
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