Evaluation of Intraoperative, Local Site Injections of Liposomal Bupivacaine as an Alternative to Standard Local Anesthetics in Patients Undergoing Total Hip Arthroplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- OSF Healthcare System
- Enrollment
- 173
- Primary Endpoint
- Comparing physical function of the control group with the experimental group
Study Overview
Brief Summary
This study aims to compare the effectiveness of liposomal bupivacaine (LB) versus standard of practice local injection containing plain bupivacaine.
Detailed Description
Investigation of liposomal bupivacaine to determine if this drug is a valid alternative to standard of care local anesthesia based on evaluation in total hip arthroplasty This is a retrospective cohort study of consecutive patients undergoing THA at 3 hospitals within a U.S. healthcare system from January 2013 to July 2016. The control group received the standard of care undergoing THA (plain bupivacaine or ropivacaine), while the LB group received a mixture containing this drug as the alternative to the standard care. The outcome variables include hospital length of stay, readmissions, total hospital costs, patient pain scores, discharge disposition, morphine equivalent opioid consumption, and postoperative patient ambulation. Generalized linear models were employed to examine aforementioned outcomes controlling for age, gender, race, BMI, alcohol use, tobacco use, and surgeons..
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Males or females over the age of 18
- •have undergone a THA surgery during the period of interest January 2013 to July 2016).
Exclusion Criteria
- •excluded from the study based on the following criteria:
- •Concurrent, painful, physical condition or concurrent surgery that may require analgesic treatment in the postoperative period for pain that is not strictly related to the surgical treatment;
- •Uncontrolled anxiety, schizophrenia, or other psychiatric disorder; and
- •Significant renal or hepatic insufficiency.
Outcomes
Primary Outcomes
Comparing physical function of the control group with the experimental group
Time Frame: 43 months
distance in feet walked
Comparing total hospital costs of the control group with the experimental group
Time Frame: 43 months
Number of dollars
Comparing length of stay in acute care facility of the control group with the experimental group
Time Frame: 43 months
number of days
Secondary Outcomes
No secondary outcomes reported
Investigators
Ed Rainville
Clinical Pharmacy Supervisor
OSF Healthcare System