A Phase 4 interventional study of Paravertebral Block and Placebo Comparator in Mitral Valve Insufficiency, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-03-15.
Sponsored by NYU Langone Health · Phase 4, Interventional, and Treatment
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.
459 studies on the registry are indexed under Mitral Valve Insufficiency; 148 are open to participants now.
This study's enrollment of 60 is close to the median of 61 across 274 interventional studies indexed under Mitral Valve Insufficiency.
Browse Mitral Valve Insufficiency studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patient receiving a PVB prior to robotic mitral valve surgery
Other: Paravertebral Block
Patients who did not receive PVB
Other: Placebo Comparator
Paravertebral nerve block injection
No block Patients who did not receive PVB
Postoperative Fentanyl
Time frame: 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
Time frame: 24 hours
Participant Satisfaction
Participants were asked whether or not they were satisfied with their postoperative pain control (yes or no)
Time frame: 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)
Time frame: 48 hours
| Milestone | Paravertebral Block | No Block |
|---|---|---|
| Started | 30 | 30 |
| Completed | 27 | 23 |
| Not completed | 3 | 7 |
| microgram/kilogram | Paravertebral Block | No Block |
|---|---|---|
| Postoperative Fentanyl | 4.51 ± 2.5 | 6.14 ± 2.88 |
Possible scores range from 0-10, with 0 being no pain and 10 being highest level of pain
| units on a scale | Paravertebral Block | No Block |
|---|---|---|
| Visual Analog Scale (VAS) Pain Scores | 3.33 ± 1.52 | 4.13 ± 1.25 |
Participants were asked whether or not they were satisfied with their postoperative pain control (yes or no)
| percentage of "yes" responders | Paravertebral Block | No Block |
|---|---|---|
| Participant Satisfaction | 100 | 86.7 |
Participants were asked to score their satisfaction with their postoperative pain control on a scale of 0 (least satisfied) to 10 (most satisfied)
| units on a scale | Paravertebral Block | No Block |
|---|---|---|
| Participant Satisfaction Score | 8.44 ± 1.25 | 6.83 ± 1.90 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Paravertebral Block | — | 0/30 (0%) | 0/30 (0%) |
| No Block | — | 0/30 (0%) | 0/30 (0%) |
| Age, Continuous(years) | Paravertebral Block | No Block | Total |
|---|---|---|---|
| Mean | 60.1 ± 12.2 | 62.2 ± 11.9 | 61.15 ± 12.05 |
| Sex: Female, Male(Participants) | Paravertebral Block | No Block | Total |
|---|---|---|---|
| Female | 5 | 12 | 17 |
| Male | 25 | 18 | 43 |
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
NYU Langone Health