Trial Outcomes & Findings for The Use of Paravertebral Block for Cardiac Surgery (NCT NCT02180893)

NCT ID: NCT02180893

Last Updated: 2016-03-15

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 60 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2016-03-15

Participant Flow

Participant milestones

Measure	Paravertebral Block Patient receiving a PVB prior to robotic mitral valce surgery Paravertebral Block: Paravertebral nerve block injection	No Block Patients who did not receive PVB Placebo Comparator: No block Patients who did not receive PVB
Overall Study STARTED	30	30
Overall Study COMPLETED	27	23
Overall Study NOT COMPLETED	3	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Use of Paravertebral Block for Cardiac Surgery

Baseline characteristics by cohort

Measure	Paravertebral Block n=30 Participants Patient receiving a PVB prior to robotic mitral valce surgery Paravertebral Block: Paravertebral nerve block injection	No Block n=30 Participants Patients who did not receive PVB Placebo Comparator: No block Patients who did not receive PVB	Total n=60 Participants Total of all reporting groups
Age, Continuous	60.1 years STANDARD_DEVIATION 12.2 • n=93 Participants	62.2 years STANDARD_DEVIATION 11.9 • n=4 Participants	61.15 years STANDARD_DEVIATION 12.05 • n=27 Participants
Sex: Female, Male Female	5 Participants n=93 Participants	12 Participants n=4 Participants	17 Participants n=27 Participants
Sex: Female, Male Male	25 Participants n=93 Participants	18 Participants n=4 Participants	43 Participants n=27 Participants

PRIMARY outcome

Timeframe: 24 hours

Outcome measures

Measure	Paravertebral Block n=27 Participants Patient receiving a PVB prior to robotic mitral valve surgery Paravertebral Block: Paravertebral nerve block injection	No Block n=23 Participants Patients who did not receive PVB Placebo Comparator: No block Patients who did not receive PVB
Postoperative Fentanyl	4.51 microgram/kilogram Standard Deviation 2.5	6.14 microgram/kilogram Standard Deviation 2.88

PRIMARY outcome

Timeframe: 24 hours

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

Outcome measures

Measure	Paravertebral Block n=27 Participants Patient receiving a PVB prior to robotic mitral valve surgery Paravertebral Block: Paravertebral nerve block injection	No Block n=23 Participants Patients who did not receive PVB Placebo Comparator: No block Patients who did not receive PVB
Visual Analog Scale (VAS) Pain Scores	3.33 units on a scale Standard Deviation 1.52	4.13 units on a scale Standard Deviation 1.25

SECONDARY outcome

Timeframe: 48 hours

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

Outcome measures

Measure	Paravertebral Block n=27 Participants Patient receiving a PVB prior to robotic mitral valve surgery Paravertebral Block: Paravertebral nerve block injection	No Block n=23 Participants Patients who did not receive PVB Placebo Comparator: No block Patients who did not receive PVB
Participant Satisfaction	100 percentage of "yes" responders	86.7 percentage of "yes" responders

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Paravertebral Block n=27 Participants Patient receiving a PVB prior to robotic mitral valve surgery Paravertebral Block: Paravertebral nerve block injection	No Block n=23 Participants Patients who did not receive PVB Placebo Comparator: No block Patients who did not receive PVB
Participant Satisfaction Score	8.44 units on a scale Standard Deviation 1.25	6.83 units on a scale Standard Deviation 1.90

Adverse Events

Paravertebral Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Peter Neuberger

NYU Langone Medical Center

Phone: 212 263 5821

Email: Peter.Neuburger@nyumc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place