Trial Outcomes & Findings for Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures (NCT NCT02499575)
NCT ID: NCT02499575
Last Updated: 2017-05-17
Results Overview
Compare time to first opioid use over 72 hours between groups
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
2 participants
Primary outcome timeframe
Daily through the third day (72 hours) post-surgery
Results posted on
2017-05-17
Participant Flow
Participant milestones
| Measure |
Regional Block
Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).
0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine
|
Regional Block Plus Exparel
Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.
0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine
Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Regional Block
Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).
0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine
|
Regional Block Plus Exparel
Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.
0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine
Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures
Baseline characteristics by cohort
| Measure |
Regional Block
n=1 Participants
Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).
0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine
|
Regional Block Plus Exparel
Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.
0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine
Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
62 years
n=5 Participants
|
—
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Daily through the third day (72 hours) post-surgeryCompare time to first opioid use over 72 hours between groups
Outcome measures
| Measure |
Regional Block
n=1 Participants
Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).
0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine
|
Regional Block Plus Exparel
Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.
0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine
Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)
|
|---|---|---|
|
Opioid Use as Measured by Questionnaire
|
6 hours
|
—
|
PRIMARY outcome
Timeframe: Daily through the third day (72 hours) post-surgeryCompare total opioid use (reported as total morphine equivalents) over 72 hours between groups.
Outcome measures
| Measure |
Regional Block
n=1 Participants
Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).
0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine
|
Regional Block Plus Exparel
Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.
0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine
Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)
|
|---|---|---|
|
Total Opioid Use as Measured by Questionnaire
|
18 morphine equivalents
|
—
|
SECONDARY outcome
Timeframe: Through 72 hours post-surgery (0, 6, 12, 24, 36, 48, 60, and 72 hours post-surgery)Evaluate patient-reported pain scores (scale of 0 (no pain) - 10 (worst pain)) at 0, 6, 12, 24, 36, 48, 60, and 72 hours following surgery
Outcome measures
| Measure |
Regional Block
n=1 Participants
Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).
0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine
|
Regional Block Plus Exparel
Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.
0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine
Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)
|
|---|---|---|
|
Pain Relief Measured by Defense and Veterans Pain Scale
Pain score time 0
|
0 units on scale of 0 -10
|
—
|
|
Pain Relief Measured by Defense and Veterans Pain Scale
Pain score time 6hrs
|
3 units on scale of 0 -10
|
—
|
|
Pain Relief Measured by Defense and Veterans Pain Scale
Pain score time 12hrs
|
3 units on scale of 0 -10
|
—
|
|
Pain Relief Measured by Defense and Veterans Pain Scale
Pain score time 24hrs
|
2 units on scale of 0 -10
|
—
|
|
Pain Relief Measured by Defense and Veterans Pain Scale
Pain score time 36hrs
|
3 units on scale of 0 -10
|
—
|
|
Pain Relief Measured by Defense and Veterans Pain Scale
Pain score time 48hrs
|
3 units on scale of 0 -10
|
—
|
|
Pain Relief Measured by Defense and Veterans Pain Scale
Pain score time 60hrs
|
2 units on scale of 0 -10
|
—
|
|
Pain Relief Measured by Defense and Veterans Pain Scale
Pain score time 72hrs
|
2 units on scale of 0 -10
|
—
|
Adverse Events
Regional Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Regional Block Plus Exparel
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place