Osteoarthritis, Hip, Osteoarthritis, Knee, Osteoarthritis, Shoulder
Conditions
Keywords
Total knee arthroplasty, Total shoulder arthroplasty, Total hip arthroplasty, Total joint arthroplasty, Hip replacement, Knee replacement, Shoulder replacement
Brief summary
The purpose of this study is to determine whether liposomal bupivacaine is effective in the management of pain following total joint arthroplasty, as compared to standard of care analgesia.
Detailed description
Liposomal bupivacaine (Exparel®) is a local anesthetic made up of liposomal encapsulated bupivacaine. It is designed to be injected at the time of surgery into the local soft tissues. Because of its unique liposomal delivery system, Liposomal bupivacaine (Exparel®) has been shown to provide up to 96 hours of pain relief following surgeries. This makes it an attractive option in total joint arthroplasty patients. Combined with the proven efficacy of regional anesthesia, intraoperative liposomal bupivacaine (Exparel®) may provide extended pain relief following total joint arthroplasty. This has the potential to avoid the need for opioid medications. With better pain control, medication side effects can be avoided and patient's length of stay in the hospital can be shortened.
Interventions
DRUGLiposomal bupivacaine
Sponsors
OhioHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis of osteoarthritis 2. Elected to undergo primary TKA, THA, or TSA
Exclusion criteria
1. Age \< 18 years 2. Pregnant or breastfeeding 3. Non-English speaking 4. Unable to give informed consent 5. Previous open hip, knee or shoulder surgery 6. Pre-determined patients discharging to ECF 7. Patients with allergies to bupivacaine 8. Patients currently taking opioid pain medication 9. Patients with contraindication to nerve blocks 10. Patients undergoing simultaneous bilateral joint replacement, as this would require \>1 dose of liposomal bupivacaine (Exparel®) per patient for each surgical site 11. Patients with severe hepatic disease 12. Patients with chronic heart disease as defined as a decreased ejection fraction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of Stay in Hospital (Days) | Participants were followed for the duration of hospital stay, an expected average of 3 days |
Secondary
| Measure | Time frame |
|---|---|
| Time to Post-operative Rescue Opioids (Hours) | Immediately following discharge from operating room until the participant was discharged from the hospital, an expected average of 3 days |
| Readmission or Emergency Department (ED) Visit Due to Pain Control Within 30 Days | Date of discharge through 30 days following discharge |
Countries
United States
Participant flow
Recruitment details
Recruitment period July 1, 2014 to September 30, 2015 for patients undergoing total hip, knee or shoulder arthroplasty at OhioHealth Riverside Methodist Hospital.
Pre-assignment details
Patients were randomized in a one to one fashion to one of two study groups within each surgical group. 10 patients were excluded after enrollment due to dual enrollment in another study, changes in anesthesia plan or improper dose of study drug. These 10 patients were not included in the analysis.
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Analgesia THA:
All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine
Injection into capsular tissue after placement of the acetabular component:
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline
TKA:
All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine All patients will receive an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc
Injection into posterior capsule of the knee:
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline
TSA:
All patients will receive a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.
Standard of care analgesia | 107 |
| Liposomal Bupivacaine THA:
Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue
TKA:
Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue
TSA:
All patients will receive a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.
Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle
Liposomal bupivacaine
Standard of care analgesia | 104 |
| Total | 211 |
Baseline characteristics
| Characteristic | Standard of Care Analgesia | Liposomal Bupivacaine | Total |
|---|---|---|---|
| Age, Continuous | 66.5 years STANDARD_DEVIATION 8.4 | 65.9 years STANDARD_DEVIATION 9.1 | 66.3 years STANDARD_DEVIATION 8.6 |
| Sex: Female, Male Female | 57 Participants | 61 Participants | 118 Participants |
| Sex: Female, Male Male | 50 Participants | 43 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 107 | 2 / 104 |
| serious Total, serious adverse events | 0 / 107 | 0 / 104 |
Outcome results
Primary
Length of Stay in Hospital (Days)
Time frame: Participants were followed for the duration of hospital stay, an expected average of 3 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care Analgesia | Length of Stay in Hospital (Days) | 2.0 days |
| Liposomal Bupivacaine | Length of Stay in Hospital (Days) | 2.0 days |
p-value: 0.764Wilcoxon (Mann-Whitney)
Secondary
Readmission or Emergency Department (ED) Visit Due to Pain Control Within 30 Days
Time frame: Date of discharge through 30 days following discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care Analgesia | Readmission or Emergency Department (ED) Visit Due to Pain Control Within 30 Days | 2 participants |
| Liposomal Bupivacaine | Readmission or Emergency Department (ED) Visit Due to Pain Control Within 30 Days | 4 participants |
p-value: 0.656Fisher Exact
Secondary
Time to Post-operative Rescue Opioids (Hours)
Time frame: Immediately following discharge from operating room until the participant was discharged from the hospital, an expected average of 3 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care Analgesia | Time to Post-operative Rescue Opioids (Hours) | 7.7 hours |
| Liposomal Bupivacaine | Time to Post-operative Rescue Opioids (Hours) | 11.8 hours |
p-value: 0.206Wilcoxon (Mann-Whitney)