Liposomal Bupivacaine Versus Standard Analgesia in Total Joint Arthroplasty (TJA)

Not Applicable

Completed

• Conditions: Osteoarthritis, Hip; Osteoarthritis, Knee; Osteoarthritis, Shoulder
• Interventions: Drug: Standard of care analgesia; Drug: Liposomal bupivacaine

• Registration Number: NCT02197273
• Lead Sponsor: OhioHealth

Brief Summary

The purpose of this study is to determine whether liposomal bupivacaine is effective in the management of pain following total joint 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 joint arthroplasty patients. Combined with the proven efficacy of regional anesthesia, intraoperative liposomal bupivacaine (Exparel®) may provide extended pain relief following total joint 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 Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-17
• Study First Submitted QC: 2014-07-18
• Study First Posted: 2014-07-22
• Primary Completion: 2015-09
• Study Completion: 2015-10
• Results First Submitted: 2016-05-10
• Status Verified: 2016-08
• Results First Submitted QC: 2016-08-30
• Last Update Submitted: 2016-08-30
• Results First Posted: 2016-10-21
• Last Update Posted: 2016-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

Inclusion Criteria

1. Clinical diagnosis of osteoarthritis
2. Elected to undergo primary TKA, THA, or TSA

Exclusion Criteria

1. Age < 18 years
2. Pregnant or breastfeeding
3. Non-English speaking
4. Unable to give informed consent
5. Previous open hip, knee or shoulder surgery
6. Pre-determined patients discharging to ECF
7. Patients with allergies to bupivacaine
8. Patients currently taking opioid pain medication
9. Patients with contraindication to nerve blocks
10. Patients undergoing simultaneous bilateral joint replacement, as this would require >1 dose of liposomal bupivacaine (Exparel®) per patient for each surgical site
11. Patients with severe hepatic disease
12. Patients with chronic heart disease as defined as a decreased ejection fraction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care analgesia	Standard of care analgesia	Total Hip Arthroplasty (THA): All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine Injection into capsular tissue after placement of the acetabular component: 0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline Total Knee Arthroplasty (TKA): All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine All patients will receive an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc Injection into posterior capsule of the knee: 0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline Total Shoulder Arthroplasty (TSA): All patients will receive a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.
Liposomal bupivacaine	Standard of care analgesia	THA: Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue TKA: Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue TSA: All patients will receive a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine. Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle
Liposomal bupivacaine	Liposomal bupivacaine	THA: Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue TKA: Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue TSA: All patients will receive a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine. Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle

Primary Outcome Measures

Name	Time	Method
Length of Stay in Hospital (Days)	Participants were followed for the duration of hospital stay, an expected average of 3 days

Secondary Outcome Measures

Name	Time	Method
Time to Post-operative Rescue Opioids (Hours)	Immediately following discharge from operating room until the participant was discharged from the hospital, an expected average of 3 days
Readmission or Emergency Department (ED) Visit Due to Pain Control Within 30 Days	Date of discharge through 30 days following discharge

Trial Locations

Locations (1)

OhioHealth Riverside Methodist Hospital; 🇺🇸 Columbus, Ohio, United States