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

NCT ID: NCT02197273

Last Updated: 2016-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 211 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-10-31

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.

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip; Osteoarthritis, Shoulder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standard of care analgesia

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

Liposomal bupivacaine

Intervention Type: DRUG

Standard of care analgesia

Intervention Type: DRUG

Interventions

Liposomal bupivacaine

Intervention Type: DRUG

Standard of care analgesia

Intervention Type: DRUG

Other Intervention Names

Exparel; Bupivacaine; Ropivacaine; Fentanyl; Solumedrol; Morphine; Saline; Epinephrine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OhioHealth

OTHER

Sponsor Role: lead

Responsible Party

Deborah Napier

Clinical Outcomes Manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah Napier, BSN,RN,MA

Role: PRINCIPAL_INVESTIGATOR

OhioHealth

Locations

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, United States

Countries

United States

Other Identifiers

OH1-14-00529

Identifier Type: -

Identifier Source: org_study_id