Pain, PostoperativePhase 4NCT02426164
Liposomal Bupivacaine in Total Knee Arthroplasty
A Phase 4 study testing Liposomal bupivacaine and bupivacaine HCl, morphine, epinephrine, methylprednisolone in people with Pain, Postoperative and Arthroplasty, Replacement, Knee, run by Miller Orthopedic Specialists at 1 site in United States.
Trial summary
Liposomal bupivacaine is a novel local anesthetic designed for prolonged pain relief. Despite its long-acting analgesic potential, liposomal bupivacaine is significantly more expensive than other local anesthetic alternatives. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pain, Postoperative, Arthroplasty, Replacement, Knee, Osteoarthritis
- What is being tested?
- Liposomal bupivacaine and bupivacaine HCl, morphine, epinephrine, methylprednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jun 2017
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing a primary unilateral total knee arthroplasty by the PI of the trial
Who cannot join
- Patients with a sensitivity to marcaine
- Pregnant or lactating women
- Non-English speaking individuals
Trial locations and contacts
1 site in 1 country.
United States1 site
Miller Orthopedic Specialists
Council Bluffs, Iowa, 51503
About this study
Official title: Analgesic Efficacy of Liposomal Bupivacaine in Total Knee Arthroplasty
Liposomal bupivacaine is a novel local anesthetic designed for prolonged pain relief. Despite its long-acting analgesic potential, liposomal bupivacaine is significantly more expensive than other local anesthetic alternatives. The primary aim of this investigation is to examine whether or not liposomal bupivacaine provides superior pain relief or clinically significant opioid-sparing effects versus a control to justify its cost.
- Being tested
- Liposomal bupivacaine, bupivacaine HCl, morphine, epinephrine, methylprednisolone
- Medical subject headings
- Pain, Postoperative, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
Also called Exparel
Periarticular infiltration of the liposomal bupivacaine with 20cc of normal saline
bupivacaine HCl, morphine, epinephrine, methylprednisoloneDrug
Periarticular infiltration of 24c of bupivacaine HCl, 0.8cc morphine, 0.3cc epinephrine, and 1cc of methylprednisolone
| Study group | Role | What they receive |
|---|---|---|
| Liposomal bupivacaine | Active comparator | Periarticular infiltration of 20cc of liposomal bupivacaine with 20cc of normal saline administered prior to cementation of knee implants Receives: Drug: Liposomal bupivacaine |
| bupivacaine HCl, morphine, epinephrine, methylprednisolone | Active comparator | Periarticular infiltration of 24c of bupivacaine HCl, 0.8cc morphine, 0.3cc epinephrine, and 1cc of methylprednisolone administered prior to cementation of knee implants Receives: Drug: bupivacaine HCl, morphine, epinephrine, methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean visual analog scale (VAS) pain scores
Self-reported pain scores from 0=no pain to 10=severe pain
Measured: Night of surgery
Mean visual analog scale (VAS) pain scores
Self-reported pain scores from 0=no pain to 10=severe pain
Measured: Post-operative day 1
Mean visual analog scale (VAS) pain scores
Self-reported pain scores from 0=no pain to 10=severe pain
Measured: Post-operative day 2
Pain assessment phone call
Subjects will be called on post-operative day three by one of the investigators of the study. Subjects will be asked to rate their current pain level from 1 to 10 and to rate their worst pain level from 1 to 10 that day.
Measured: Post-operative day 3
Secondary outcomes (1)
Complications
Number of patients with complications
Measured: Complications will be followed for the duration of patients' hospital stay, an expected average of 2-3 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Why it stopped: Could not receive facility approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miller Orthopedic Specialists
- Sponsor type
- University, hospital or other
- Collaborators
- Creighton University Medical Center, CHI Health Mercy Hospital
- Responsible party
- Sponsor
- Investigators
- Clifford K Boese, MD, Principal investigator, Miller Orthopedic Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426164
- Sponsor's protocol ID
- 633913
- Status last verified
- Apr 2015
- First submitted
- 14 Apr 2015
- Last updated
- 22 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Liposomal Bupivacaine in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02426164
- Acronym / sponsor ID
- 633913
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Could not receive facility approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Miller Orthopedic SpecialistsUniversity, hospital or other
- Collaborators
- Creighton University Medical Center, CHI Health Mercy Hospital
- Study start
- Jun 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 24 Apr 2015 (estimated)
- 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.
Liposomal bupivacaine is a novel local anesthetic designed for prolonged pain relief. Despite its long-acting analgesic potential, liposomal bupivacaine is significantly more expensive than other local anesthetic alternatives. The primary aim of this investigation is to examine whether or not liposomal bupivacaine provides superior pain relief or clinically significant opioid-sparing effects versus a control to justify its cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal bupivacaine | Active comparator | Drug: Liposomal bupivacainePeriarticular infiltration of 20cc of liposomal bupivacaine with 20cc of normal saline administered prior to cementation of knee implants |
| bupivacaine HCl, morphine, epinephrine, methylprednisolone | Active comparator | Drug: bupivacaine HCl, morphine, epinephrine, methylprednisolonePeriarticular infiltration of 24c of bupivacaine HCl, 0.8cc morphine, 0.3cc epinephrine, and 1cc of methylprednisolone administered prior to cementation of knee implants |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing a primary unilateral total knee arthroplasty by the PI of the trial
Key exclusion criteria (3 listed)
- Patients with a sensitivity to marcaine
- Pregnant or lactating women
- Non-English speaking individuals
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: ExparelPeriarticular infiltration of the liposomal bupivacaine with 20cc of normal saline | Drug | Liposomal bupivacaine |
| bupivacaine HCl, morphine, epinephrine, methylprednisolonePeriarticular infiltration of 24c of bupivacaine HCl, 0.8cc morphine, 0.3cc epinephrine, and 1cc of methylprednisolone | Drug | bupivacaine HCl, morphine, epinephrine, methylprednisolone |
Primary outcome
Mean visual analog scale (VAS) pain scores
Time frame: Night of surgery
Self-reported pain scores from 0=no pain to 10=severe pain
Mean visual analog scale (VAS) pain scores
Time frame: Post-operative day 1
Self-reported pain scores from 0=no pain to 10=severe pain
Mean visual analog scale (VAS) pain scores
Time frame: Post-operative day 2
Self-reported pain scores from 0=no pain to 10=severe pain
Pain assessment phone call
Time frame: Post-operative day 3
Subjects will be called on post-operative day three by one of the investigators of the study. Subjects will be asked to rate their current pain level from 1 to 10 and to rate their worst pain level from 1 to 10 that day.
1 secondary outcome
Complications
Time frame: Complications will be followed for the duration of patients' hospital stay, an expected average of 2-3 days.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
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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.
Clifford K Boese, MD principal investigator
Miller Orthopedic Specialists
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liposomal bupivacaine and bupivacaine HCl, morphine, epinephrine, methylprednisolone in people with Pain, Postoperative and Arthroplasty, Replacement, Knee, run by Miller Orthopedic Specialists 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 1 inclusion and 3 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: withdrawn, as of the sponsor's last update on 22 Mar 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Mean visual analog scale (VAS) pain scores (time frame: Night of surgery). The study lists 4 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 22 Mar 2016.