Hip DiseaseNCT03341104
Evaluation of LB in THA
An observational study of Hip Disease, run by OSF Healthcare System.
Trial summary
This study aims to compare the effectiveness of liposomal bupivacaine (LB) versus standard of practice local injection containing plain bupivacaine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Disease
- What is being tested?
- Bupivacaine liposome
- How many people
- 173 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 30 Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients admitted to acute care facilities for total hip arthroplasty
Who may be able to join
- Males or females over the age of 18
- have undergone a THA surgery during the period of interest January 2013 to July 2016).
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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..
- Conditions
- Hip Disease
- Being tested
- Bupivacaine liposome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine liposomeDrug
Also called bupivacaine
Replace bupivacaine with bupivacaine liposome
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing physical function of the control group with the experimental group
distance in feet walked
Measured: 43 months
Comparing length of stay in acute care facility of the control group with the experimental group
number of days
Measured: 43 months
Comparing total hospital costs of the control group with the experimental group
Number of dollars
Measured: 43 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start1 Jan 2013
- Primary completion30 Jul 2016
- Study completion30 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- OSF Healthcare System
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois College of Medicine at Peoria
- Responsible party
- Principal investigator, Ed Rainville, OSF Healthcare System
- Investigators
- Ed Rainville, Principal investigator, OSF HealthCare Ssytem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341104
- Sponsor's protocol ID
- hipstudy2017
- Status last verified
- Nov 2017
- First submitted
- 8 Nov 2017
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intraoperative, Local Site Injections of Liposomal Bupivacaine as an Alternative to Standard Local Anesthetics in Patients Undergoing Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT03341104
- Acronym / sponsor ID
- hipstudy2017
- Conditions
- Hip Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- OSF Healthcare SystemUniversity, hospital or other
- Collaborators
- University of Illinois College of Medicine at Peoria
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 30 Jul 2016 (actual)
- Study completion
- 30 Jul 2016 (actual)
- First posted
- 14 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the effectiveness of liposomal bupivacaine (LB) versus standard of practice local injection containing plain bupivacaine.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients admitted to acute care facilities for total hip arthroplasty
Key inclusion criteria (2 listed)
- Males or females over the age of 18
- have undergone a THA surgery during the period of interest January 2013 to July 2016).
Key exclusion criteria (4 listed)
- excluded from the study based on the following criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine liposomeAlso: bupivacaineReplace bupivacaine with bupivacaine liposome | Drug | – |
Primary outcome
Comparing physical function of the control group with the experimental group
Time frame: 43 months
distance in feet walked
Comparing length of stay in acute care facility of the control group with the experimental group
Time frame: 43 months
number of days
Comparing total hospital costs of the control group with the experimental group
Time frame: 43 months
Number of dollars
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Individual participant dataSharing planned: No
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3D-Printed Pelvic Models for Planning Complex Total Hip Arthroplasty
Developmental Dysplasia of the Hip, Acetabular Bone Loss
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Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
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Not yet recruitingPhase 4
Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ed Rainville principal investigator
OSF HealthCare Ssytem
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Disease, run by OSF Healthcare System.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing physical function of the control group with the experimental group (time frame: 43 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.