Liposomal Bupivacaine Versus Standard Analgesia in TJA

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02197273
• Other study ID #: OH1-14-00529
• Status: Completed
• Phase: N/A
• First received: July 17, 2014
• Last updated: March 29, 2016
• Start date: July 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: OhioHealth
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• 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 joint 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee
• Osteoarthritis, Shoulder

Intervention

Drug:
• Liposomal bupivacaine

• Standard of care analgesia

Locations

Country	Name	City	State
United States	OhioHealth Riverside Methodist Hospital	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	Length of stay in hospital (days)		Participants will be followed for the duration of hospital stay, an expected average of 3 days	No
Secondary	Time to post-operative rescue opioids (minutes)		Immediately following discharge from operating room until the participant is discharged from the hospital, an expected average of 3 days	No
Secondary	Readmission or ED visit due to pain control within 30 days		Date of discharge through 30 days following discharge	No