The Use of Paravertebral Block for Cardiac Surgery

Phase 4

Completed

• Conditions: Mitral Valve Insufficiency
• Interventions: Other: Paravertebral Block; Other: Placebo Comparator

• Registration Number: NCT02180893
• Lead Sponsor: NYU Langone Health

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Study First Submitted: 2014-07-01
• Study First Submitted QC: 2014-07-02
• Study First Posted: 2014-07-03
• Status Verified: 2016-02
• Results First Submitted: 2016-02-16
• Results First Submitted QC: 2016-02-16
• Last Update Submitted: 2016-02-16
• Results First Posted: 2016-03-15
• Last Update Posted: 2016-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patients over the age of 18 years of age undergoing robotic mitral valve surgery.
• have capacity to understand and sign consent form

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paravertebral block	Paravertebral Block	Patient receiving a PVB prior to robotic mitral valve surgery
No block	Placebo Comparator	Patients who did not receive PVB

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

NYU Langone Medical Center; 🇺🇸 New York, New York, United States