Clinical trial NCT02219087: Liposomal Bupivacaine Versus Standard of Care in Total Knee Surgery
Official title: Local Liposomal Bupivacaine Versus Standard of Care in an Opioid-Sparing Analgesic Approach to Total Knee Arthroplasty: A Prospective, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Total knee arthroplasty
Total joint arthroplasty
Knee replacement
Osteoarthritis of the knee
Lead sponsor: OhioHealth
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 60
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 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.

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)

Primary outcomes:
measure: Number Physical Therapy Sessions Necessary for Discharge
timeFrame: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
Secondary outcomes:
measure: Mean Visual Analog Scale (VAS) Pain Scores During Hospital Stay
timeFrame: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
measure: Length of Stay (LOS, in Days)
timeFrame: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
measure: Opioid Consumption in Oral Morphine Equivalents (OMEs, in Milligrams)
timeFrame: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
measure: Number of Participants With Opioid-related Adverse Events (ORAEs) During Hospital Stay
timeFrame: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
measure: Total Cost of Care (Dollars)
timeFrame: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
measure: Hospital Readmission Not Including Admissions Planned Procedures
timeFrame: Participants will be followed for 30 days after leaving the hospital.
Other outcomes:
Locations:
city: Columbus
country: United States
facility: OhioHealth Grant Medical Center Bone and Joint Center
state: Ohio
Study officials:
affiliation: OhioHealth
name: Robert Fada, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: OhioHealth
name: Sara Jordan, PharmD, BCPS
role: STUDY_DIRECTOR
References: