Liposomal Bupivacaine Versus Standard of Care in Total Knee Surgery

NCT ID: NCT02219087

Last Updated: 2018-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-03-31

Brief Summary

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.

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 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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Liposomal bupivacaine

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: DRUG

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.

Interventions

Liposomal bupivacaine

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Exparel

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OhioHealth

OTHER

Sponsor Role: lead

Responsible Party

Robert Fada, MD

Orthopedic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Fada, MD

Role: PRINCIPAL_INVESTIGATOR

OhioHealth

Sara Jordan, PharmD, BCPS

Role: STUDY_DIRECTOR

OhioHealth

Locations

OhioHealth Grant Medical Center Bone and Joint Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

14-0024

Identifier Type: -

Identifier Source: org_study_id