Mitral Valve Insufficiency
Conditions
Brief 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 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.
Interventions
OTHERParavertebral Block
Paravertebral nerve block injection
OTHERPlacebo Comparator
No block Patients who did not receive PVB
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* patients over the age of 18 years of age undergoing robotic mitral valve surgery. * have capacity to understand and sign consent form
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Fentanyl | 24 hours | — |
| Visual Analog Scale (VAS) Pain Scores | 24 hours | Possible scores range from 0-10, with 0 being no pain and 10 being highest level of pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Satisfaction | 48 hours | Participants were asked whether or not they were satisfied with their postoperative pain control (yes or no) |
| Participant Satisfaction Score | 48 hours | Participants were asked to score their satisfaction with their postoperative pain control on a scale of 0 (least satisfied) to 10 (most satisfied) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paravertebral Block Patient receiving a PVB prior to robotic mitral valce surgery
Paravertebral Block: Paravertebral nerve block injection | 30 |
| No Block Patients who did not receive PVB
Placebo Comparator: No block
Patients who did not receive PVB | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Paravertebral Block | No Block | Total |
|---|---|---|---|
| Age, Continuous | 60.1 years STANDARD_DEVIATION 12.2 | 62.2 years STANDARD_DEVIATION 11.9 | 61.15 years STANDARD_DEVIATION 12.05 |
| Sex: Female, Male Female | 5 Participants | 12 Participants | 17 Participants |
| Sex: Female, Male Male | 25 Participants | 18 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Postoperative Fentanyl
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paravertebral Block | Postoperative Fentanyl | 4.51 microgram/kilogram | Standard Deviation 2.5 |
| No Block | Postoperative Fentanyl | 6.14 microgram/kilogram | Standard Deviation 2.88 |
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
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paravertebral Block | Visual Analog Scale (VAS) Pain Scores | 3.33 units on a scale | Standard Deviation 1.52 |
| No Block | Visual Analog Scale (VAS) Pain Scores | 4.13 units on a scale | Standard Deviation 1.25 |
Secondary
Participant Satisfaction
Participants were asked whether or not they were satisfied with their postoperative pain control (yes or no)
Time frame: 48 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paravertebral Block | Participant Satisfaction | 100 percentage of yes responders |
| No Block | Participant Satisfaction | 86.7 percentage of yes responders |
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)
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paravertebral Block | Participant Satisfaction Score | 8.44 units on a scale | Standard Deviation 1.25 |
| No Block | Participant Satisfaction Score | 6.83 units on a scale | Standard Deviation 1.9 |