Trial Outcomes & Findings for Comparing Post-Op Narcotic Usage in Patients Receiving Periarticular Exparel vs. Standard Periarticular Joint Inj (NCT NCT02682498)
NCT ID: NCT02682498
Last Updated: 2017-07-07
Results Overview
A comparison of group means between the control group and study group with regards to 48 hour opioid use.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
38 participants
Primary outcome timeframe
48 hours
Results posted on
2017-07-07
Participant Flow
Participant milestones
| Measure |
EXPAREL® Bupivacaine Liposome Suspension
Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.
(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery.
|
Standard Periarticular Joint Injection
A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
20
|
|
Overall Study
COMPLETED
|
18
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing Post-Op Narcotic Usage in Patients Receiving Periarticular Exparel vs. Standard Periarticular Joint Inj
Baseline characteristics by cohort
| Measure |
EXPAREL® Bupivacaine Liposome Suspension
n=20 Participants
Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.
(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery.
|
Standard Periarticular Joint Injection
n=18 Participants
A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.14 years
STANDARD_DEVIATION 10.18 • n=99 Participants
|
60 years
STANDARD_DEVIATION 12.83 • n=107 Participants
|
60 years
STANDARD_DEVIATION 11 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 48 hoursA comparison of group means between the control group and study group with regards to 48 hour opioid use.
Outcome measures
| Measure |
EXPAREL® Bupivacaine Liposome Suspension
n=20 Participants
Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.
(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery.
|
Standard Periarticular Joint Injection
n=18 Participants
A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
|
|---|---|---|
|
48 Hour Post-surgical Opioid Use
|
5.32 morphine equivalents
Standard Deviation 1.72
|
5.07 morphine equivalents
Standard Deviation 2.05
|
SECONDARY outcome
Timeframe: Up to 48 hoursPopulation: The vast majority of the patients had been discharged by 72 hours post-op, making this outcome low-powered and not useful. Because of this we used the 48 hour pain measurement.
Post anesthesia care unit (recovery room) opioid use in total mg morphine IV equivalent in comparison of standard knee injection post-operatively.
Outcome measures
| Measure |
EXPAREL® Bupivacaine Liposome Suspension
n=20 Participants
Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.
(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery.
|
Standard Periarticular Joint Injection
n=18 Participants
A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
|
|---|---|---|
|
Recovery Room Opioid Use
|
5 Total morphine equivalents
Interval 0.0 to 10.0
|
5 Total morphine equivalents
Interval 5.0 to 20.0
|
SECONDARY outcome
Timeframe: Up to 48 hoursPopulation: The vast majority of the patients had been discharged by 72 hours post-op, making this outcome low-powered and not useful. Because of this we used the 48 hour pain measurement.
Opioid use will be monitored daily from the time of admission in comparison of standard knee injection post-operatively.
Outcome measures
| Measure |
EXPAREL® Bupivacaine Liposome Suspension
n=20 Participants
Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.
(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery.
|
Standard Periarticular Joint Injection
n=18 Participants
A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
|
|---|---|---|
|
Average Daily Opioid Use During Admission
|
100 Total Morphine Equivalents
Interval 0.0 to 150.0
|
103 Total Morphine Equivalents
Interval 0.0 to 275.0
|
SECONDARY outcome
Timeframe: Up to 48 hoursPopulation: The vast majority of the patients had been discharged by 72 hours post-op, making this outcome low-powered and not useful. Because of this we used the 48 hour pain measurement.
Examining the average daily patient pain score in comparison of standard knee injection post-operatively. The measure is the Visual-Analog-Scale (VAS) for subjective pain reporting. The minimum 0 (no pain) and the maximum is 10 (worst pain imagineable). There is only one measure in the scale (i.e. there are no subscales). Lower scores on the VAS scale equate to less pain and are therefore desirable.
Outcome measures
| Measure |
EXPAREL® Bupivacaine Liposome Suspension
n=20 Participants
Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.
(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery.
|
Standard Periarticular Joint Injection
n=18 Participants
A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
|
|---|---|---|
|
Average Daily Patient Pain Score
|
4.75 Visual Analog Scale Rating
Interval 0.0 to 9.5
|
5.75 Visual Analog Scale Rating
Interval 0.0 to 9.0
|
SECONDARY outcome
Timeframe: Up to 1 monthPopulation: The vast majority of the patients had been discharged by 72 hours post-op, making this outcome low-powered and not useful. Because of this we used the 48 hour pain measurement.
Examining the post-operative complication in comparison of standard knee injection post-operatively.
Outcome measures
| Measure |
EXPAREL® Bupivacaine Liposome Suspension
n=18 Participants
Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.
(Bupivacaine Liposome Injectable Suspension): Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery.
|
Standard Periarticular Joint Injection
n=20 Participants
A standard joint injection of 100ml which contains Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml will be injected into the soft tissues around the joint after surgery.
|
|---|---|---|
|
Post-operative Complications
|
0 complications
|
0 complications
|
Adverse Events
EXPAREL® Bupivacaine Liposome Suspension
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Periarticular Joint Injection
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