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Evaluation of LB in THA

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ClinicalTrials.gov Identifier: NCT03341104
Recruitment Status : Completed
First Posted : November 14, 2017
Last Update Posted : November 14, 2017
Sponsor:
Collaborator:
University of Illinois College of Medicine at Peoria
Information provided by (Responsible Party):
Ed Rainville, OSF Healthcare System

Study Description
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Brief Summary:
This study aims to compare the effectiveness of liposomal bupivacaine (LB) versus standard of practice local injection containing plain bupivacaine.

Condition or disease Intervention/treatment
Hip Disease Drug: Bupivacaine liposome

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
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Study Type : Observational
Actual Enrollment : 173 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of Intraoperative, Local Site Injections of Liposomal Bupivacaine as an Alternative to Standard Local Anesthetics in Patients Undergoing Total Hip Arthroplasty
Actual Study Start Date : January 1, 2013
Actual Primary Completion Date : July 30, 2016
Actual Study Completion Date : July 30, 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Drug: Bupivacaine liposome
    Replace bupivacaine with bupivacaine liposome
    Other Name: bupivacaine

Outcome Measures
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Primary Outcome Measures :
  1. Comparing physical function of the control group with the experimental group [ Time Frame: 43 months ]
    distance in feet walked

  2. Comparing length of stay in acute care facility of the control group with the experimental group [ Time Frame: 43 months ]
    number of days

  3. Comparing total hospital costs of the control group with the experimental group [ Time Frame: 43 months ]
    Number of dollars


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adult patients admitted to acute care facilities for total hip arthroplasty
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:

    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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03341104


Sponsors and Collaborators
OSF Healthcare System
University of Illinois College of Medicine at Peoria
Investigators
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Principal Investigator: Ed Rainville OSF HealthCare Ssytem
More Information
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Responsible Party: Ed Rainville, Clinical Pharmacy Supervisor, OSF Healthcare System
ClinicalTrials.gov Identifier: NCT03341104    
Other Study ID Numbers: hipstudy2017
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents