Liposomal Bupivacaine Versus Standard Analgesia in TJA
Information source: OhioHealth
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis, Knee; Osteoarthritis, Hip; Osteoarthritis, Shoulder
Intervention: Liposomal bupivacaine (Drug); Standard of care analgesia (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: OhioHealth Official(s) and/or principal investigator(s):
Elizabeth Brill, MD, Principal Investigator, Affiliation: OhioHealth
Overall contact:
Deborah Napier, BSN, RN, MA, Phone: 614-566-5575, Email: deborah.napier@ohiohealth.com
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.
Clinical Details
Official title: Efficacy of Liposomal Bupivacaine Versus Standard Analgesia in Pain Management of Total Joint Arthroplasty
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Length of stay in hospital (days)
Secondary outcome: Time to post-operative rescue opioids (minutes)Readmission or ED visit due to pain control within 30 days
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Deborah Napier, BSN, RN, MA, Phone: 614-566-5575, Email: deborah.napier@ohiohealth.com
OhioHealth Riverside Methodist Hospital, Columbus, Ohio 43214, United States; Recruiting
Elizabeth Brill, MD, Principal Investigator
Additional Information
Starting date: July 2014
Last updated: April 30, 2015
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