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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Liposomal bupivacaine

Standard of care analgesia

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Total knee arthroplasty, Total shoulder arthroplasty, Total hip arthroplasty, Total joint arthroplasty, Hip replacement, Knee replacement, Shoulder replacement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

OhioHealth Riverside Methodist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of care analgesia

Liposomal bupivacaine

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Length of Stay in Hospital (Days)

Secondary Outcome Measures

Time to Post-operative Rescue Opioids (Hours)

Readmission or Emergency Department (ED) Visit Due to Pain Control Within 30 Days

Full Information

NCT ID

NCT02197273

First Posted

July 17, 2014

Last Updated

August 30, 2016

Sponsor

OhioHealth

1. Study Identification

Unique Protocol Identification Number

NCT02197273

Brief Title

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

Official Title

Efficacy of Liposomal Bupivacaine Versus Standard Analgesia in Pain Management of Total Joint Arthroplasty

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

July 2014 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

OhioHealth

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee, Osteoarthritis, Hip, Osteoarthritis, Shoulder

Keywords

Total knee arthroplasty, Total shoulder arthroplasty, Total hip arthroplasty, Total joint arthroplasty, Hip replacement, Knee replacement, Shoulder replacement

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

211 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard of care analgesia

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Liposomal bupivacaine

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Liposomal bupivacaine

Other Intervention Name(s)

Exparel

Intervention Type

Drug

Intervention Name(s)

Standard of care analgesia

Other Intervention Name(s)

Bupivacaine, Ropivacaine, Fentanyl, Solumedrol, Morphine, Saline, Epinephrine

Primary Outcome Measure Information:

Title

Length of Stay in Hospital (Days)

Time Frame

Participants were followed for the duration of hospital stay, an expected average of 3 days

Secondary Outcome Measure Information:

Title

Time to Post-operative Rescue Opioids (Hours)

Time Frame

Immediately following discharge from operating room until the participant was discharged from the hospital, an expected average of 3 days

Title

Readmission or Emergency Department (ED) Visit Due to Pain Control Within 30 Days

Time Frame

Date of discharge through 30 days following discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of osteoarthritis Elected to undergo primary TKA, THA, or TSA Exclusion Criteria: Age < 18 years Pregnant or breastfeeding Non-English speaking Unable to give informed consent Previous open hip, knee or shoulder surgery Pre-determined patients discharging to ECF Patients with allergies to bupivacaine Patients currently taking opioid pain medication Patients with contraindication to nerve blocks Patients undergoing simultaneous bilateral joint replacement, as this would require >1 dose of liposomal bupivacaine (Exparel®) per patient for each surgical site Patients with severe hepatic disease Patients with chronic heart disease as defined as a decreased ejection fraction

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Deborah Napier, BSN,RN,MA

Organizational Affiliation

OhioHealth

Official's Role

Principal Investigator

Facility Information:

Facility Name

OhioHealth Riverside Methodist Hospital

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43214

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

No

Osteoarthritis, Knee, Osteoarthritis, Hip, Osteoarthritis, Shoulder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial