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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

Page last updated: August 23, 2015

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