Osteoarthritis, KneeNCT02219087

Liposomal Bupivacaine Versus Standard of Care in Total Knee Surgery

A study testing Liposomal bupivacaine in people with Osteoarthritis, Knee, run by OhioHealth at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether liposomal bupivacaine is effective in the management of pain following total knee arthroplasty, as compared to standard of care analgesia. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Osteoarthritis, Knee
What is being tested?: Liposomal bupivacaine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Aug 2014to Mar 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

At least 18 years of age
Scheduled to undergo total knee arthroplasty (TKA) performed by the principal investigator

Who cannot join

Age <18 years
Pregnant or breastfeeding
Non-English-speaking
Unable to give informed consent
Patients admitted from or discharged to a medical facility (due to likelihood of limited mobility and/or required minimum lengths of stay, confounding primary outcome), including other hospitals, skilled nursing facilities, long-term acute care hospitals, etc.
Patients unable to complete a device-assisted 140 foot walk at baseline

Show all 9Show fewer

Patients with contraindication(s) to any bupivacaine or ropivacaine formulation, to nerve blocks or any of the local agents used (IV morphine, ketorolac, or methylprednisolone).
Patients on a long-acting maintenance opioid prior to admission for surgery (e.g., methadone, oxycontin)
Patients undergoing simultaneous bilateral TKAs, as this would increase the dose of Exparel per patient (we are limited to one dose per patient)

Trial locations and contacts

1 site in 1 country.

United States1 site

OhioHealth Grant Medical Center Bone and Joint Center
Columbus, Ohio, 43215

Other trials in United States

About this study

Official title: Local Liposomal Bupivacaine Versus Standard of Care in an Opioid-Sparing Analgesic Approach to Total Knee Arthroplasty: A Prospective, Randomized, Controlled Trial

The purpose of this study is to determine whether liposomal bupivacaine is effective in the management of pain following total knee arthroplasty, as compared to standard of care analgesia.

Read the detailed description

Liposomal bupivacaine (Exparel®) is a local anesthetic made up of liposomal encapsulated bupivacaine. It is designed to be injected at the time of surgery into the local soft tissues. Because of its unique liposomal delivery system, Liposomal bupivacaine (Exparel®) has been shown to provide up to 96 hours of pain relief following surgeries. This makes it an attractive option in total knee arthroplasty patients. Combined with the proven efficacy of regional anesthesia, intraoperative liposomal bupivacaine (Exparel®) may provide extended pain relief following total knee arthroplasty. This has the potential to avoid the need for opioid medications. With better pain control, medication side effects can be avoided and patient's length of stay in the hospital can be shortened.

Conditions: Osteoarthritis, Knee
Being tested: Liposomal bupivacaine, Standard of Care
Keywords: Total knee arthroplasty, Total joint arthroplasty, Knee replacement, Osteoarthritis of the knee
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Liposomal bupivacaineDrug
Also called Exparel
Standard of CareDrug
Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.

Study groups in NCT02219087
Study group	Role	What they receive
Liposomal Bupivacaine	Experimental	Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas. Receives: Drug: Liposomal bupivacaine
Standard of Care	Active comparator	Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone. Receives: Drug: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Number Physical Therapy Sessions Necessary for Discharge
Number of physical therapy (PT) sessions necessary for discharge. A significant decrease in the number of sessions will be defined as ≥ 2. Typically, there are 2 sessions per day, with each patient completing an average of 4-5 sessions during their admission.
Measured: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.

Secondary outcomes (6)

Mean Visual Analog Scale (VAS) Pain Scores During Hospital Stay
VAS was measured using a scale that ranged from 0 to 10. Higher scores indicate more pain, or a worse outcome. Patients had pain measured a variable number of times following surgery before discharge. Mean VAS score during the hospital stay for each patient was calculated
Measured: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
Length of Stay (LOS, in Days)
Measured: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
Opioid Consumption in Oral Morphine Equivalents (OMEs, in Milligrams)
Measured: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
Number of Participants With Opioid-related Adverse Events (ORAEs) During Hospital Stay
1. Nausea
2. Vomiting
3. Constipation
4. Ileus
5. Pruritus
6. Respiratory depression
7. Over-sedation
Measured: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
Total Cost of Care (Dollars)
Measured: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
Hospital Readmission Not Including Admissions Planned Procedures
Measured: Participants will be followed for 30 days after leaving the hospital.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2014Mar 2016

First posted18 Aug 2014 (estimated)
Study startAug 2014
Primary completionMar 2016
Study completionMar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Osteoarthritis, KneeStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02219087
Sponsor's protocol ID: 14-0024
Status last verified: Dec 2017
First submitted: 15 Aug 2014
Last updated: 2 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis, Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Local Liposomal Bupivacaine Versus Standard of Care in an Opioid-Sparing Analgesic Approach to Total Knee Arthroplasty: A Prospective, Randomized, Controlled Trial
ClinicalTrials.gov ID: NCT02219087
Acronym / sponsor ID: 14-0024
Conditions: Osteoarthritis, Knee
Keywords: Total knee arthroplasty, Total joint arthroplasty, Knee replacement, Osteoarthritis of the knee
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: OhioHealthUniversity, hospital or other
Study start: Aug 2014
Primary completion: Mar 2016 (actual)
Study completion: Mar 2016 (actual)
First posted: 18 Aug 2014 (estimated)
Results: Posted 2 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine whether liposomal bupivacaine is effective in the management of pain following total knee arthroplasty, as compared to standard of care analgesia.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Liposomal Bupivacaine	Experimental	Drug: Liposomal bupivacainePre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas.
Standard of Care	Active comparator	Drug: Standard of CarePre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

At least 18 years of age
Scheduled to undergo total knee arthroplasty (TKA) performed by the principal investigator

Key exclusion criteria (9 listed)

Age <18 years
Pregnant or breastfeeding
Non-English-speaking
Unable to give informed consent
Patients admitted from or discharged to a medical facility (due to likelihood of limited mobility and/or required minimum lengths of stay, confounding primary outcome), including other hospitals, skilled nursing facilities, long-term acute care hospitals, etc.

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
Liposomal bupivacaineAlso: Exparel	Drug	Liposomal Bupivacaine
Standard of CarePre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.	Drug	Standard of Care

Primary outcome

Number Physical Therapy Sessions Necessary for Discharge
Time frame: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
Number of physical therapy (PT) sessions necessary for discharge. A significant decrease in the number of sessions will be defined as ≥ 2. Typically, there are 2 sessions per day, with each patient completing an average of 4-5 sessions during their admission.

6 secondary outcomes

Mean Visual Analog Scale (VAS) Pain Scores During Hospital Stay
Time frame: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
Length of Stay (LOS, in Days)
Time frame: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
Opioid Consumption in Oral Morphine Equivalents (OMEs, in Milligrams)
Time frame: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
Number of Participants With Opioid-related Adverse Events (ORAEs) During Hospital Stay
Time frame: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
Total Cost of Care (Dollars)
Time frame: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.
Hospital Readmission Not Including Admissions Planned Procedures
Time frame: Participants will be followed for 30 days after leaving the hospital.

Results and safety

Results posted to the registry on 2 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Liposomal Bupivacaine	30	30
Standard of Care	30	29

Primary outcome: Number Physical Therapy Sessions Necessary for Discharge

Time frame: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.. Mean (Standard Deviation). Unit: Physical Therapy Sessions

Measure	Liposomal Bupivacaine n = 30	Standard of Care n = 29
Value	3.0 (1.2)	3.6 (1.3)

Liposomal Bupivacaine vs Standard of Care: p = 0.137, t-test, 2 sided

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Liposomal Bupivacaine	0 of 30 (0%)	13 of 30 (43.3%)	Not reported
Standard of Care	0 of 29 (0%)	11 of 29 (37.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Osteoarthritis, Knee

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Holistic Healing for Knee Osteoarthritis
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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.

Robert Fada, MD principal investigator

OhioHealth

Sara Jordan, PharmD, BCPS study director

OhioHealth

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Liposomal bupivacaine in people with Osteoarthritis, Knee, run by OhioHealth at 1 site in United States.

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 9 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 2 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 2 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number Physical Therapy Sessions Necessary for Discharge (time frame: Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02219087.

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 2 Jan 2018.