NCT03341104

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

3.6 years

First QC Date

November 8, 2017

Last Update Submit

November 9, 2017

Conditions

Hip Disease

Outcome Measures

Primary Outcomes (3)

  • 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

Interventions

Bupivacaine liposomeDRUG

Replace bupivacaine with bupivacaine liposome

Also known as: bupivacaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Males or females over the age of 18
  • have undergone a THA surgery during the period of interest January 2013 to July 2016).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Ed Rainville

    OSF HealthCare Ssytem

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Pharmacy Supervisor

Study Record Dates

First Submitted

November 8, 2017

First Posted

November 14, 2017

Study Start

January 1, 2013

Primary Completion

July 30, 2016

Study Completion

July 30, 2016

Last Updated

November 14, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share