Liposomal Bupivacaine Versus Standard of Care in Total Knee Surgery

NCT02219087 | Completed Results

• 1 other identifier: 14-0024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Total knee arthroplasty; Total joint arthroplasty; Knee replacement; Osteoarthritis of the knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Mean Visual Analog Scale (VAS) Pain Scores During Hospital Stay

  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

  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.

Study Arms (2)

Liposomal Bupivacaine

EXPERIMENTAL

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

Standard of Care

ACTIVE COMPARATOR

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

Interventions

Liposomal bupivacaine DRUG

Also known as: Exparel

Liposomal Bupivacaine

Standard of Care 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.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• OhioHealth: lead

Study Sites (1)

OhioHealth Grant Medical Center Bone and Joint Center

Columbus, Ohio, 43215, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Sara Jordan Clinical Pharmacist for Surgery Services
• Organization: OhioHealth

sara.jordan@ohiohealth.com

614-461-8174

Study Officials

• Robert Fada, MD

  OhioHealth

  PRINCIPAL INVESTIGATOR

• Sara Jordan, PharmD, BCPS

  OhioHealth

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon

Study Record Dates

• First Submitted: August 15, 2014
• First Posted: August 18, 2014
• Study Start: August 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: January 2, 2018
• Results First Posted: January 2, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)