Liposomal Bupivacaine Versus Standard of Care in Total Knee Surgery

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02219087
• Other study ID #: 14-0024
• Status: Completed
• Phase: N/A
• First received: August 15, 2014
• Last updated: December 1, 2017
• Start date: August 2014
• Est. completion date: March 2016

Study information

• Verified date: December 2017
• Source: OhioHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Liposomal bupivacaine

• 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.

Locations

Country	Name	City	State
United States	OhioHealth Grant Medical Center Bone and Joint Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
OhioHealth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Length of Stay (LOS, in Days)		Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
Secondary	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.
Secondary	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.
Secondary	Total Cost of Care (Dollars)		Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
Secondary	Hospital Readmission Not Including Admissions Planned Procedures		Participants will be followed for 30 days after leaving the hospital.