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Clinical Trials/NCT03341104
NCT03341104
Completed
Not Applicable

Evaluation of Intraoperative, Local Site Injections of Liposomal Bupivacaine as an Alternative to Standard Local Anesthetics in Patients Undergoing Total Hip Arthroplasty

OSF Healthcare System0 sites173 target enrollmentJanuary 1, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hip Disease
Sponsor
OSF Healthcare System
Enrollment
173
Primary Endpoint
Comparing physical function of the control group with the experimental group
Status
Completed
Last Updated
8 years ago

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..

Registry
clinicaltrials.gov
Start Date
January 1, 2013
End Date
July 30, 2016
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ed Rainville

Clinical Pharmacy Supervisor

OSF Healthcare System

Eligibility Criteria

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

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