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OpenTrials
Completed

NCT Number: NCT03341104

Evaluation of LB in THA

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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..

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bupivacaine liposome

Drug

Replace bupivacaine with bupivacaine liposome

Other names: bupivacaine

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

OSF Healthcare System

Other

Collaborators

  • University of Illinois College of Medicine at Peoria

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 14, 2017
Registry last updated
Nov 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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