Liposomal Bupivacaine Versus Standard of Care in Total Knee Surgery

Local Liposomal Bupivacaine Versus Standard of Care in an Opioid-Sparing Analgesic Approach to Total Knee Arthroplasty: A Prospective, Randomized, Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Drug: Liposomal bupivacaine; Drug: Standard of Care

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43215
      • OhioHealth Grant Medical Center Bone and Joint Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Liposomal bupivacaine; Other Names: Exparel
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number Physical Therapy Sessions Necessary for Discharge	Number of physical therapy (PT) sessions necessary for discharge. A significant decrease in the number of sessions will be defined as ≥ 2. Typically, there are 2 sessions per day, with each patient completing an average of 4-5 sessions during their admission.	Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Visual Analog Scale (VAS) Pain Scores During Hospital Stay	VAS was measured using a scale that ranged from 0 to 10. Higher scores indicate more pain, or a worse outcome. Patients had pain measured a variable number of times following surgery before discharge. Mean VAS score during the hospital stay for each patient was calculated	Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
Length of Stay (LOS, in Days)		Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
Opioid Consumption in Oral Morphine Equivalents (OMEs, in Milligrams)		Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
Number of Participants With Opioid-related Adverse Events (ORAEs) During Hospital Stay	Nausea; Vomiting; Constipation; Ileus; Pruritus; Respiratory depression; Over-sedation	Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
Total Cost of Care (Dollars)		Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
Hospital Readmission Not Including Admissions Planned Procedures		Participants will be followed for 30 days after leaving the hospital.

Collaborators and Investigators

• Sponsor: OhioHealth
• Investigators: Principal Investigator: Robert Fada, MD, OhioHealth; Study Director: Sara Jordan, PharmD, BCPS, OhioHealth

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: August 15, 2014
• First Submitted That Met QC Criteria: August 15, 2014
• First Posted (Estimate): August 18, 2014

Study Record Updates

• Last Update Posted (Actual): January 2, 2018
• Last Update Submitted That Met QC Criteria: December 1, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Total knee arthroplasty; Knee replacement; Osteoarthritis of the knee; Total joint arthroplasty
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 14-0024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO