Evaluation of LB in THA

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

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

Study Overview

• Status: Completed
• Conditions: Hip Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 173

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adult patients admitted to acute care facilities for total hip arthroplasty

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: OSF Healthcare System
• Collaborators: University of Illinois College of Medicine at Peoria
• Investigators: Principal Investigator: Ed Rainville, OSF HealthCare Ssytem

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): July 30, 2016
• Study Completion (Actual): July 30, 2016

Study Registration Dates

• First Submitted: November 8, 2017
• First Submitted That Met QC Criteria: November 9, 2017
• First Posted (Actual): November 14, 2017

Study Record Updates

• Last Update Posted (Actual): November 14, 2017
• Last Update Submitted That Met QC Criteria: November 9, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: hipstudy2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No