Trial Outcomes & Findings for Liposomal Bupivacaine Versus Standard of Care in Total Knee Surgery (NCT NCT02219087)
NCT ID: NCT02219087
Last Updated: 2018-01-02
Results Overview
Number of physical therapy (PT) sessions necessary for discharge. A significant decrease in the number of sessions will be defined as ≥ 2. Typically, there are 2 sessions per day, with each patient completing an average of 4-5 sessions during their admission.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
Results posted on
2018-01-02
Participant Flow
Participant milestones
| Measure |
Liposomal Bupivacaine
Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas.
Liposomal bupivacaine
|
Standard of Care
Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.
ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Liposomal Bupivacaine
Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas.
Liposomal bupivacaine
|
Standard of Care
Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.
ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia
|
|---|---|---|
|
Overall Study
Randomization envelope pulled out of seq
|
0
|
1
|
Baseline Characteristics
Liposomal Bupivacaine Versus Standard of Care in Total Knee Surgery
Baseline characteristics by cohort
| Measure |
Liposomal Bupivacaine
n=30 Participants
Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas.
Liposomal bupivacaine
|
Standard of Care
n=29 Participants
Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.
ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.0 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
61.2 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
63.1 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.Number of physical therapy (PT) sessions necessary for discharge. A significant decrease in the number of sessions will be defined as ≥ 2. Typically, there are 2 sessions per day, with each patient completing an average of 4-5 sessions during their admission.
Outcome measures
| Measure |
Liposomal Bupivacaine
n=30 Participants
Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas.
Liposomal bupivacaine
|
Standard of Care
n=29 Participants
Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.
ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia
|
|---|---|---|
|
Number Physical Therapy Sessions Necessary for Discharge
|
3.0 Physical Therapy Sessions
Standard Deviation 1.2
|
3.6 Physical Therapy Sessions
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.VAS was measured using a scale that ranged from 0 to 10. Higher scores indicate more pain, or a worse outcome. Patients had pain measured a variable number of times following surgery before discharge. Mean VAS score during the hospital stay for each patient was calculated
Outcome measures
| Measure |
Liposomal Bupivacaine
n=30 Participants
Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas.
Liposomal bupivacaine
|
Standard of Care
n=29 Participants
Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.
ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia
|
|---|---|---|
|
Mean Visual Analog Scale (VAS) Pain Scores During Hospital Stay
|
4.4 Units on a scale
Standard Deviation 1.3
|
4.7 Units on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.Outcome measures
| Measure |
Liposomal Bupivacaine
n=30 Participants
Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas.
Liposomal bupivacaine
|
Standard of Care
n=29 Participants
Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.
ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia
|
|---|---|---|
|
Length of Stay (LOS, in Days)
|
2.5 Days
Standard Deviation 0.8
|
2.3 Days
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.Outcome measures
| Measure |
Liposomal Bupivacaine
n=30 Participants
Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas.
Liposomal bupivacaine
|
Standard of Care
n=29 Participants
Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.
ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia
|
|---|---|---|
|
Opioid Consumption in Oral Morphine Equivalents (OMEs, in Milligrams)
|
274.6 Milligrams
Standard Deviation 121.0
|
304.8 Milligrams
Standard Deviation 143.4
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.1. Nausea 2. Vomiting 3. Constipation 4. Ileus 5. Pruritus 6. Respiratory depression 7. Over-sedation
Outcome measures
| Measure |
Liposomal Bupivacaine
n=30 Participants
Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas.
Liposomal bupivacaine
|
Standard of Care
n=29 Participants
Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.
ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia
|
|---|---|---|
|
Number of Participants With Opioid-related Adverse Events (ORAEs) During Hospital Stay
|
13 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.Outcome measures
| Measure |
Liposomal Bupivacaine
n=30 Participants
Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas.
Liposomal bupivacaine
|
Standard of Care
n=29 Participants
Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.
ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia
|
|---|---|---|
|
Total Cost of Care (Dollars)
|
64582.90 Dollars
Interval 55424.5 to 121583.5
|
62601.50 Dollars
Interval 52435.9 to 97367.5
|
SECONDARY outcome
Timeframe: Participants will be followed for 30 days after leaving the hospital.Outcome measures
| Measure |
Liposomal Bupivacaine
n=30 Participants
Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas.
Liposomal bupivacaine
|
Standard of Care
n=29 Participants
Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.
ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia
|
|---|---|---|
|
Hospital Readmission Not Including Admissions Planned Procedures
|
0 participants
|
1 participants
|
Adverse Events
Liposomal Bupivacaine
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Liposomal Bupivacaine
n=30 participants at risk
Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas.
Liposomal bupivacaine
|
Standard of Care
n=29 participants at risk
Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.
ropivacaine, morphine ,ketorolac, methylprednisolone: Standard of care analgesia
|
|---|---|---|
|
Gastrointestinal disorders
Nausea/Vomiting
|
33.3%
10/30
|
31.0%
9/29
|
|
Gastrointestinal disorders
Constipation
|
20.0%
6/30
|
13.8%
4/29
|
|
Nervous system disorders
Oversedation
|
13.3%
4/30
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Depression
|
0.00%
0/30
|
3.4%
1/29
|
Additional Information
Sara Jordan Clinical Pharmacist for Surgery Services
OhioHealth
Phone: 614-461-8174
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place