Liposomal Bupivacaine Versus Standard of Care in Total Knee Surgery

OhioHealth

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Drug: Liposomal bupivacaine; Drug: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT02219087

14-0024

Details and patient eligibility

About

The purpose of this study is to determine whether liposomal bupivacaine is effective in the management of pain following total knee arthroplasty, as compared to standard of care analgesia.

Full 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 knee arthroplasty patients. Combined with the proven efficacy of regional anesthesia, intraoperative liposomal bupivacaine (Exparel®) may provide extended pain relief following total knee 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years of age
• Scheduled to undergo total knee arthroplasty (TKA) performed by the principal investigator

Exclusion criteria

• Age <18 years
• Pregnant or breastfeeding
• Non-English-speaking
• Unable to give informed consent
• Patients admitted from or discharged to a medical facility (due to likelihood of limited mobility and/or required minimum lengths of stay, confounding primary outcome), including other hospitals, skilled nursing facilities, long-term acute care hospitals, etc.
• Patients unable to complete a device-assisted 140 foot walk at baseline
• Patients with contraindication(s) to any bupivacaine or ropivacaine formulation, to nerve blocks or any of the local agents used (IV morphine, ketorolac, or methylprednisolone).
• Patients on a long-acting maintenance opioid prior to admission for surgery (e.g., methadone, oxycontin)
• Patients undergoing simultaneous bilateral TKAs, as this would increase the dose of Exparel per patient (we are limited to one dose per patient)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Liposomal Bupivacaine

Experimental group

Description:

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.

Treatment:

Drug: Liposomal bupivacaine

Standard of Care

Active Comparator group

Description:

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.

Treatment:

Drug: Standard of Care