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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03341104
Other study ID # hipstudy2017
Secondary ID
Status Completed
Phase N/A
First received November 8, 2017
Last updated November 9, 2017
Start date January 1, 2013
Est. completion date July 30, 2016

Study information

Verified date November 2017
Source OSF Healthcare System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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..


Recruitment information / eligibility

Status Completed
Enrollment 173
Est. completion date July 30, 2016
Est. primary completion date July 30, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Bupivacaine liposome
Replace bupivacaine with bupivacaine liposome

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
OSF Healthcare System University of Illinois College of Medicine at Peoria

Outcome

Type Measure Description Time frame Safety issue
Primary Comparing physical function of the control group with the experimental group distance in feet walked 43 months
Primary Comparing length of stay in acute care facility of the control group with the experimental group number of days 43 months
Primary Comparing total hospital costs of the control group with the experimental group Number of dollars 43 months
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