Phase 4
Completed N=60
The Use of Paravertebral Block for Cardiac Surgery
Mitral Valve Insufficiency
Source: ClinicalTrials.gov NCT02180893 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Postoperative Fentanyl — 4.51; 6.14 microgram/kilogram
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Fentanyl |
4.51; 6.14 | — |
| PRIMARY Visual Analog Scale (VAS) Pain Scores |
3.33; 4.13 | — |
| SECONDARY Participant Satisfaction |
100; 86.7 | — |
| SECONDARY Participant Satisfaction Score |
8.44; 6.83 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02180893). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.