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OpenTrials
Completed

NCT Number: NCT02180893

The Use of Paravertebral Block for Cardiac Surgery

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NYU Langone Medical Center

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

paravertebral block

Other

Paravertebral nerve block injection

Placebo Comparator

Other

No block

Patients who did not receive PVB

Primary outcomes

  1. Postoperative Fentanyl

    Time frame: 24 hours

  2. Visual Analog Scale (VAS) Pain Scores

    Time frame: 24 hours

    Possible scores range from 0-10, with 0 being no pain and 10 being highest level of pain

Secondary outcomes

  1. Participant Satisfaction

    Time frame: 48 hours

    Participants were asked whether or not they were satisfied with their postoperative pain control (yes or no)

  2. Participant Satisfaction Score

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Study of Paravertebral Block for Cardiac Surgery

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 3, 2014
Registry last updated
Mar 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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