Trial Outcomes & Findings for Exparel in Minimally Invasive Cardiac Surgery (NCT NCT02008370)
NCT ID: NCT02008370
Last Updated: 2019-10-04
Results Overview
The other primary endpoint of this study is the effectiveness of analgesia from the thoracotomy and chest tube site infiltrations as measured by the overall postsurgical analgesic use, (converted to morphine equivalents).
TERMINATED
PHASE4
9 participants
5 days
2019-10-04
Participant Flow
Participant milestones
| Measure |
Exparel Infiltration
Exparel infiltrated into wound and chest tube sites
Exparel infiltration: Exparel infiltrated into wound and chest tube sites
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Exparel Infiltration
Exparel infiltrated into wound and chest tube sites
Exparel infiltration: Exparel infiltrated into wound and chest tube sites
|
|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
Baseline Characteristics
Exparel in Minimally Invasive Cardiac Surgery
Baseline characteristics by cohort
| Measure |
Exparel Infiltration
n=7 Participants
Exparel infiltrated into wound and chest tube sites
Exparel infiltration: Exparel infiltrated into wound and chest tube sites
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Age, Continuous
|
59 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 5 daysPopulation: None of the patients completed to date 5: Lost to follow-up
The other primary endpoint of this study is the effectiveness of analgesia from the thoracotomy and chest tube site infiltrations as measured by the overall postsurgical analgesic use, (converted to morphine equivalents).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 days +/- 5 daysPopulation: Lost of follow-up.
Overall rating of subject satisfaction with postsurgical pain control
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First 5 post-op daysPopulation: Lost to follow up
Subject reported surgical pain (using an 11-point numeric rating scale ).
Outcome measures
Outcome data not reported
Adverse Events
Exparel Infiltration
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place