NCT02180893

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2014

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

March 15, 2016

Completed
Last Updated

March 15, 2016

Status Verified

February 1, 2016

Enrollment Period

1.2 years

First QC Date

July 1, 2014

Results QC Date

February 16, 2016

Last Update Submit

February 16, 2016

Conditions

Mitral Valve Insufficiency

Outcome Measures

Primary Outcomes (2)

  • Postoperative Fentanyl

    24 hours

  • Visual Analog Scale (VAS) Pain Scores

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

    24 hours

Secondary Outcomes (2)

  • Participant Satisfaction

    48 hours

  • Participant Satisfaction Score

    48 hours

Study Arms (2)

Paravertebral block

EXPERIMENTAL

Patient receiving a PVB prior to robotic mitral valve surgery

Other: Paravertebral Block

No block

PLACEBO COMPARATOR

Patients who did not receive PVB

Other: Placebo Comparator

Interventions

Paravertebral BlockOTHER

Paravertebral nerve block injection

Paravertebral block
Placebo ComparatorOTHER

No block Patients who did not receive PVB

No block

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Related Publications (2)

  • 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.

    PMID: 22364970BACKGROUND

  • 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.

    PMID: 20472625BACKGROUND

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Peter Neuberger
Organization
NYU Langone Medical Center
Peter.Neuburger@nyumc.org
212 263 5821

Study Officials

  • Peter J Neuburger, MD

    NYU

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2014

First Posted

July 3, 2014

Study Start

January 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

March 15, 2016

Results First Posted

March 15, 2016

Record last verified: 2016-02

Locations

US(1)