Liposomal Bupivacaine Versus Standard Analgesia in Total Joint Arthroplasty (TJA)
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 204
Inclusion Criteria
- Elected to undergo primary TKA, THA, or TSA
- Clinical diagnosis of osteoarthritis
- Elected to undergo primary TKA, THA, or TSA
- Clinical diagnosis of osteoarthritis
Exclusion Criteria
- Previous open hip, knee or shoulder surgery
- Pregnant or breastfeeding
- Patients with allergies to bupivacaine
- ...
- Previous open hip, knee or shoulder surgery
- Pregnant or breastfeeding
- Patients with allergies to bupivacaine
- Patients with contraindication to nerve blocks
- Patients undergoing simultaneous bilateral joint replacement, as this would require >1 dose of liposomal bupivacaine (Exparel®) per patient for each surgical site
- Patients with chronic heart disease as defined as a decreased ejection fraction
- Unable to give informed consent
- Non-English speaking
- Patients currently taking opioid pain medication
- Patients with severe hepatic disease
- Age < 18 years
- Pre-determined patients discharging to ECF
Summary
- Conditions
- Osteoarthritis Hip
- Osteoarthritis (Knee)
- Osteoarthritis Shoulder
- Osteoarthritis, Knee
- Osteoarthritis, Hip
- Osteoarthritis, Shoulder
- Type
- Interventional
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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.
Inclusion Criteria
- Elected to undergo primary TKA, THA, or TSA
- Clinical diagnosis of osteoarthritis
- Elected to undergo primary TKA, THA, or TSA
- Clinical diagnosis of osteoarthritis
Exclusion Criteria
- Previous open hip, knee or shoulder surgery
- Pregnant or breastfeeding
- Patients with allergies to bupivacaine
- ...
- Previous open hip, knee or shoulder surgery
- Pregnant or breastfeeding
- Patients with allergies to bupivacaine
- Patients with contraindication to nerve blocks
- Patients undergoing simultaneous bilateral joint replacement, as this would require >1 dose of liposomal bupivacaine (Exparel®) per patient for each surgical site
- Patients with chronic heart disease as defined as a decreased ejection fraction
- Unable to give informed consent
- Non-English speaking
- Patients currently taking opioid pain medication
- Patients with severe hepatic disease
- Age < 18 years
- Pre-determined patients discharging to ECF
Tracking Information
- NCT #
- NCT02197273
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Deborah Napier, BSN,RN,MA OhioHealth
- Deborah Napier, BSN,RN,MA OhioHealth
Get Well Soon