Clinical trial NCT02180893: The Use of Paravertebral Block for Cardiac Surgery
Official title: Study of Paravertebral Block for Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mitral Valve Insufficiency
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2014-07-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative Fentanyl
timeFrame: 24 hours
measure: Visual Analog Scale (VAS) Pain Scores
timeFrame: 24 hours
Secondary outcomes:
measure: Participant Satisfaction
timeFrame: 48 hours
measure: Participant Satisfaction Score
timeFrame: 48 hours
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: NYU
name: Peter J Neuburger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.