Trial Outcomes & Findings for Exparel vs. Standard Bupivicaine for Abdominoplasty (NCT NCT01853176)
NCT ID: NCT01853176
Last Updated: 2014-11-03
Results Overview
Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain. Patients will complete a log of pain levels experienced each morning and evening for 3 days. Score is 0-10 on a visual analog scale.
TERMINATED
PHASE4
4 participants
3 days
2014-11-03
Participant Flow
Recruitment took place at Emory University Hospital - Midtown between October 2013 through November 2013.
Participant milestones
| Measure |
Liposomal Injection Bupivicaine (Exparel)
Patients will have the maximum approved dose of Exparel, 266 mg, diluted in 20 mL normal saline, infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.
Liposomal Injection Bupivacaine (Exparel)
|
Standard Bupivicaine
Patients will receive the maximum safe allowance of 0.25% bupivacaine, or 1.5 mg/kg (eg. 150 mg or 60 mL for a 100 kg patient) infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.
Standard bupivicaine
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Liposomal Injection Bupivicaine (Exparel)
Patients will have the maximum approved dose of Exparel, 266 mg, diluted in 20 mL normal saline, infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.
Liposomal Injection Bupivacaine (Exparel)
|
Standard Bupivicaine
Patients will receive the maximum safe allowance of 0.25% bupivacaine, or 1.5 mg/kg (eg. 150 mg or 60 mL for a 100 kg patient) infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.
Standard bupivicaine
|
|---|---|---|
|
Overall Study
Study terminated
|
4
|
0
|
Baseline Characteristics
Exparel vs. Standard Bupivicaine for Abdominoplasty
Baseline characteristics by cohort
| Measure |
Liposomal Injection Bupivicaine (Exparel)
n=4 Participants
Patients will have the maximum approved dose of Exparel, 266 mg, diluted in 20 mL normal saline, infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.
Liposomal Injection Bupivacaine (Exparel)
|
Standard Bupivicaine
Patients will receive the maximum safe allowance of 0.25% bupivacaine, or 1.5 mg/kg (eg. 150 mg or 60 mL for a 100 kg patient) infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.
Standard bupivicaine
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 participants
n=99 Participants
|
—
|
0 participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 participants
n=99 Participants
|
—
|
4 participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 participants
n=99 Participants
|
—
|
0 participants
n=206 Participants
|
|
Gender
Female
|
4 participants
n=99 Participants
|
—
|
4 participants
n=206 Participants
|
|
Gender
Male
|
0 participants
n=99 Participants
|
—
|
0 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
—
|
4 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 daysContinuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain. Patients will complete a log of pain levels experienced each morning and evening for 3 days. Score is 0-10 on a visual analog scale.
Outcome measures
Outcome data not reported
Adverse Events
Liposomal Injection Bupivicaine (Exparel)
Standard Bupivicaine
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