Clinical trial NCT02197273: Liposomal Bupivacaine Versus Standard Analgesia in Total Joint Arthroplasty (TJA)
Official title: Efficacy of Liposomal Bupivacaine Versus Standard Analgesia in Pain Management of Total Joint Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip
Osteoarthritis, Shoulder
Keywords: Total knee arthroplasty
Total shoulder arthroplasty
Total hip arthroplasty
Total joint arthroplasty
Hip replacement
Knee replacement
Shoulder replacement
Lead sponsor: OhioHealth
Sponsor class: OTHER
First posted: 2014-07-22
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of Stay in Hospital (Days)
timeFrame: Participants were followed for the duration of hospital stay, an expected average of 3 days
Secondary outcomes:
measure: Time to Post-operative Rescue Opioids (Hours)
timeFrame: Immediately following discharge from operating room until the participant was discharged from the hospital, an expected average of 3 days
measure: Readmission or Emergency Department (ED) Visit Due to Pain Control Within 30 Days
timeFrame: Date of discharge through 30 days following discharge
Other outcomes:
Locations:
city: Columbus
country: United States
facility: OhioHealth Riverside Methodist Hospital
state: Ohio
Study officials:
affiliation: OhioHealth
name: Deborah Napier, BSN,RN,MA
role: PRINCIPAL_INVESTIGATOR
References: