Trial Outcomes & Findings for Comparison of Three Different Pain Blocks for Subjects Undergoing VATS (Video Assisted Thoracoscopic Surgery) Procedure. (NCT NCT03151434)
NCT ID: NCT03151434
Last Updated: 2021-01-27
Results Overview
The VAS score will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using "units on a scale" of 1-10 for documentation with 10 being the worst pain and 0 being no pain
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
147 participants
Primary outcome timeframe
Pain scores will be measured 24 hours after surgery.
Results posted on
2021-01-27
Participant Flow
Participant milestones
| Measure |
Group #1
US Guided Single Shot Paravertebral Block
US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.
|
Group #2
US Guided Paravertebral Catheter
US Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.
|
Group #3
Thoracic Epidural
Thoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.
|
|---|---|---|---|
|
Overall Study
STARTED
|
53
|
47
|
47
|
|
Overall Study
COMPLETED
|
40
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
13
|
7
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Three Different Pain Blocks for Subjects Undergoing VATS (Video Assisted Thoracoscopic Surgery) Procedure.
Baseline characteristics by cohort
| Measure |
US Guided Single Shot Paravertebral Block
n=40 Participants
group 1- US Guided Single Shot Paravertebral Block
US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.
|
US Guided Paravertebral Catheter
n=40 Participants
group 2- US Guided Paravertebral Catheter
US Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.
|
Thoracic Epidural
n=40 Participants
group 3- Thoracic Epidural
Thoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.5 years
n=5 Participants
|
62 years
n=7 Participants
|
61 years
n=5 Participants
|
62 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
|
height
|
171 Centimeter
n=5 Participants
|
167.6 Centimeter
n=7 Participants
|
173.5 Centimeter
n=5 Participants
|
170 Centimeter
n=4 Participants
|
|
weight
|
88.4 Kilogram
n=5 Participants
|
77.7 Kilogram
n=7 Participants
|
87.3 Kilogram
n=5 Participants
|
84.1 Kilogram
n=4 Participants
|
PRIMARY outcome
Timeframe: Pain scores will be measured 24 hours after surgery.The VAS score will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using "units on a scale" of 1-10 for documentation with 10 being the worst pain and 0 being no pain
Outcome measures
| Measure |
US Guided Single Shot Paravertebral Block
n=40 Participants
group 1- US Guided Single Shot Paravertebral Block
US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.
|
US Guided Paravertebral Catheter
n=40 Participants
group 2- US Guided Paravertebral Catheter
US Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.
|
Thoracic Epidural
n=40 Participants
group 3- Thoracic Epidural
Thoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.
|
|---|---|---|---|
|
The Primary Endpoint of This Study Will be VAS Pain Score at 24 Hours
|
4.0 units on a scale
Interval 3.0 to 5.5
|
4.5 units on a scale
Interval 2.5 to 6.0
|
3.0 units on a scale
Interval 1.0 to 5.0
|
PRIMARY outcome
Timeframe: Pain scores will be measured 48 hours after surgery.The VAS scores will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using"units on a scale" scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain
Outcome measures
| Measure |
US Guided Single Shot Paravertebral Block
n=40 Participants
group 1- US Guided Single Shot Paravertebral Block
US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.
|
US Guided Paravertebral Catheter
n=40 Participants
group 2- US Guided Paravertebral Catheter
US Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.
|
Thoracic Epidural
n=40 Participants
group 3- Thoracic Epidural
Thoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.
|
|---|---|---|---|
|
The Primary Endpoint of This Study Will be VAS Pain Score at 48 Hours
|
3.0 units on a scale
Interval 1.0 to 5.0
|
4.0 units on a scale
Interval 2.0 to 6.0
|
2.0 units on a scale
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Opioid consumption will be measured at 1 hour post op, 24,48, and 72 hours post op. The total amount will be recorded.Opioid consumption will be collected by a study team member post operatively up to 3 days per protocol time requirements
Outcome measures
| Measure |
US Guided Single Shot Paravertebral Block
n=40 Participants
group 1- US Guided Single Shot Paravertebral Block
US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.
|
US Guided Paravertebral Catheter
n=40 Participants
group 2- US Guided Paravertebral Catheter
US Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.
|
Thoracic Epidural
n=40 Participants
group 3- Thoracic Epidural
Thoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.
|
|---|---|---|---|
|
Secondary Endpoint Includes Total Intravenous Opioid Consumption at 72 Hours
|
57 miligram morphine equivalent
Interval 18.0 to 96.0
|
35 miligram morphine equivalent
Interval 15.0 to 89.0
|
21.3 miligram morphine equivalent
Interval 7.5 to 45.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Nausea scores will be documented at 1 hour post op, 24,48,and 72 hours after the surgery.The scores will then be averaged.Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as 0=none, 1=mild, 2=moderate, or 3=severe
Outcome measures
| Measure |
US Guided Single Shot Paravertebral Block
n=40 Participants
group 1- US Guided Single Shot Paravertebral Block
US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.
|
US Guided Paravertebral Catheter
n=40 Participants
group 2- US Guided Paravertebral Catheter
US Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.
|
Thoracic Epidural
n=40 Participants
group 3- Thoracic Epidural
Thoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.
|
|---|---|---|---|
|
Average Nausea Scores Over 72 Hours
|
0.27 units on a scale
Interval 0.0 to 3.0
|
0.27 units on a scale
Interval 0.0 to 3.0
|
0.29 units on a scale
Interval 0.0 to 3.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Sedation scores will be documented at 1 hour post op, 24,48,and 72 hours after the sugery. The scores will then be averaged.Sedation scores will be documented by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is 0=awake and alert, 1=quietly awake, 2=asleep and arousable, or 3=deep sleep.
Outcome measures
| Measure |
US Guided Single Shot Paravertebral Block
n=40 Participants
group 1- US Guided Single Shot Paravertebral Block
US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.
|
US Guided Paravertebral Catheter
n=40 Participants
group 2- US Guided Paravertebral Catheter
US Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.
|
Thoracic Epidural
n=40 Participants
group 3- Thoracic Epidural
Thoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.
|
|---|---|---|---|
|
Average Sedation Scores Over 72 Hours
|
0.38 units on a scale
Interval 0.0 to 3.0
|
0.32 units on a scale
Interval 0.0 to 3.0
|
0.22 units on a scale
Interval 0.0 to 3.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: post operatively at hour 24Subjects will be followed up at 24 hours post operatively by a study team member to document patient overall satisfaction scores. Score was recorded as 0=dissatisfied, 1=satisfied, 2=very satisfied.
Outcome measures
| Measure |
US Guided Single Shot Paravertebral Block
n=40 Participants
group 1- US Guided Single Shot Paravertebral Block
US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.
|
US Guided Paravertebral Catheter
n=40 Participants
group 2- US Guided Paravertebral Catheter
US Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.
|
Thoracic Epidural
n=40 Participants
group 3- Thoracic Epidural
Thoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.
|
|---|---|---|---|
|
Subjects Overall Satisfaction Scores
|
0.89 units on a scale
Interval 0.0 to 2.0
|
0.95 units on a scale
Interval 0.0 to 2.0
|
1.33 units on a scale
Interval 0.0 to 2.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: post operatively at hour 48Subjects will be followed up at 48 hours post operatively by a study team member to document patient overall satisfaction scores. Scores will be recorded as 0=dissatisfied, 1=satisfied, 2=very satisfied.
Outcome measures
| Measure |
US Guided Single Shot Paravertebral Block
n=40 Participants
group 1- US Guided Single Shot Paravertebral Block
US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion): Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.
|
US Guided Paravertebral Catheter
n=40 Participants
group 2- US Guided Paravertebral Catheter
US Guided Paravertebral Catheter (0.2% ropivicaine bolus): Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.
|
Thoracic Epidural
n=40 Participants
group 3- Thoracic Epidural
Thoracic Epidural (0.125% bupivicaine/hydromorphone): Epidural catheter will be placed in the thoracic region prior to surgery.
|
|---|---|---|---|
|
Subjects Overall Satisfaction Scores
|
1.19 units on a scale
Interval 0.0 to 2.0
|
1.05 units on a scale
Interval 0.0 to 2.0
|
1.32 units on a scale
Interval 0.0 to 2.0
|
Adverse Events
US Guided Single Shot Paravertebral Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
US Guided Paravertebral Catheter
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Thoracic Epidural
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
Dr. Yar Luan Yeap
Indiana University Department of Anesthesiology
Phone: 3172740275
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place