Trial Outcomes & Findings for Bupivacaine Versus Ropivacaine on Diaphragmatic Motility and Ventilatory Function (NCT NCT02059070)
NCT ID: NCT02059070
Last Updated: 2014-11-25
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
Within the first 4 days following surgery
Results posted on
2014-11-25
Participant Flow
Participant milestones
| Measure |
0.125% Bupivacaine
Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.
Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery.
|
0.2% Ropivacaine
Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.
Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
|
Overall Study
COMPLETED
|
14
|
16
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bupivacaine Versus Ropivacaine on Diaphragmatic Motility and Ventilatory Function
Baseline characteristics by cohort
| Measure |
0.125% Bupivacaine
n=14 Participants
Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.
Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery.
|
0.2% Ropivacaine
n=16 Participants
Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.
Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 Years
STANDARD_DEVIATION 18 • n=5 Participants
|
48 Years
STANDARD_DEVIATION 19 • n=7 Participants
|
51 Years
STANDARD_DEVIATION 18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within the first 4 days following surgeryOutcome measures
| Measure |
0.125% Bupivacaine
n=14 Participants
Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.
Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery.
|
0.2% Ropivacaine
n=16 Participants
Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.
Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery.
|
|---|---|---|
|
Forced Expiratory Volume at 1 Second (% Change From Baseline)
|
-22.4 percentage of change from baseline
Standard Deviation 18.3
|
-29.4 percentage of change from baseline
Standard Deviation 14.9
|
SECONDARY outcome
Timeframe: Within 36hrs following surgeryFor ultrasonographic evaluation if caudad movement of the hemidiaphragm was observed, the distance was measured recorded and assigned a positive (+) value. If paradoxical cephalad movement of the diaphragm was observed, the distance was given a negative value (-). Each measurement was performed 3 times and the best value was recorded.
Outcome measures
| Measure |
0.125% Bupivacaine
n=14 Participants
Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.
Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery.
|
0.2% Ropivacaine
n=16 Participants
Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.
Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery.
|
|---|---|---|
|
Ultrasonographic Evaluation of Diaphragmatic Excursion- Operative Side Sigh Test
|
-81.4 percentage of baseline change
Standard Deviation 37.9
|
-75.5 percentage of baseline change
Standard Deviation 35.1
|
SECONDARY outcome
Timeframe: The 24 hour period following surgeryThe total amount of oxycodone medication (mg) that the patient consumed in the 24 hours post surgery.
Outcome measures
| Measure |
0.125% Bupivacaine
n=14 Participants
Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.
Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery.
|
0.2% Ropivacaine
n=16 Participants
Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.
Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery.
|
|---|---|---|
|
Post-operative Oxycodone Use (mg)
|
33.7 mg
Standard Deviation 24.3
|
35.1 mg
Standard Deviation 33.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 36 hours of surgeryThe Visual analog pain scale ranges from 0 to 10, with higher scores indicating higher pain
Outcome measures
| Measure |
0.125% Bupivacaine
n=14 Participants
Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.
Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery.
|
0.2% Ropivacaine
n=16 Participants
Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.
Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery.
|
|---|---|---|
|
Highest Patient Pain Level
|
4.9 VAS units on a scale
Standard Deviation 2.9
|
3.5 VAS units on a scale
Standard Deviation 2.8
|
Adverse Events
0.125% Bupivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
0.2% Ropivacaine
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
Pranav Patel
Wayne State University, School of Medicine
Phone: 313-745-7233
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place