Evaluation of LB in THA

Completed

• Conditions: Hip Disease

• Registration Number: NCT03341104
• Lead Sponsor: OSF Healthcare System

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 Timeline

• Study Start: 2013-01-01
• Primary Completion: 2016-07-30
• Study Completion: 2016-07-30
• Status Verified: 2017-11
• Study First Submitted: 2017-11-08
• Study First Submitted QC: 2017-11-09
• Last Update Submitted: 2017-11-09
• Study First Posted: 2017-11-14
• Last Update Posted: 2017-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

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).

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Exclusion Criteria

• excluded from the study based on the following criteria:

  1. 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;
  2. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder; and
  3. Significant renal or hepatic insufficiency.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparing physical function of the control group with the experimental group	43 months	distance in feet walked
Comparing total hospital costs of the control group with the experimental group	43 months	Number of dollars
Comparing length of stay in acute care facility of the control group with the experimental group	43 months	number of days