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The Use of Paravertebral Block for Cardiac Surgery

Primary Purpose

Mitral Valve Insufficiency

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Paravertebral Block

Placebo Comparator

About this trial

This is an interventional treatment trial for Mitral Valve Insufficiency

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

NYU Langone Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Paravertebral block

No block

Arm Description

Patient receiving a PVB prior to robotic mitral valve surgery

Patients who did not receive PVB

Outcomes

Primary Outcome Measures

Postoperative Fentanyl

Visual Analog Scale (VAS) Pain Scores

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

Secondary Outcome Measures

Participant Satisfaction

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

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)

Full Information

NCT ID

NCT02180893

First Posted

July 1, 2014

Last Updated

February 16, 2016

Sponsor

NYU Langone Health

1. Study Identification

Unique Protocol Identification Number

NCT02180893

Brief Title

The Use of Paravertebral Block for Cardiac Surgery

Official Title

Study of Paravertebral Block for Cardiac Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mitral Valve Insufficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Paravertebral block

Arm Type

Experimental

Arm Description

Patient receiving a PVB prior to robotic mitral valve surgery

Arm Title

No block

Arm Type

Placebo Comparator

Arm Description

Patients who did not receive PVB

Intervention Type

Other

Intervention Name(s)

Paravertebral Block

Intervention Description

Paravertebral nerve block injection

Intervention Type

Other

Intervention Name(s)

Placebo Comparator

Intervention Description

No block Patients who did not receive PVB

Primary Outcome Measure Information:

Title

Postoperative Fentanyl

Time Frame

24 hours

Title

Visual Analog Scale (VAS) Pain Scores

Description

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

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Participant Satisfaction

Description

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

Time Frame

48 hours

Title

Participant Satisfaction Score

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter J Neuburger, MD

Organizational Affiliation

NYU

Official's Role

Principal Investigator

Facility Information:

Facility Name

NYU Langone Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22364970

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.

Results Reference

background

PubMed Identifier

20472625

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.

Results Reference

background

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The Use of Paravertebral Block for Cardiac Surgery

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