Evaluation of LB in THA

Hip Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03341104
• Other study ID #: hipstudy2017
• 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
• 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.

Related Conditions & MeSH terms

• Hip Disease

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