Total Knee ArthroplastyNCT02299349
Bupivacaine Liposome Suspension Versus a Concentrated Multi Drug Periarticular Injection
A study testing bupivacaine liposome suspension and concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL in people with Total Knee Arthroplasty, run by TriHealth Inc..
Trial summary
Despite a robust multimodal pain management regimen, patients undergoing total knee arthroplasty (TKA) continue to report low satisfaction with postoperative pain management. Patient satisfaction further declines with any adverse event such as a drug reaction to neuroleptic medications or a patient fall due to a… Read more about this study
- Who is it for?
- Ages 35 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- bupivacaine liposome suspension and concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Mar 2014
- 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 35 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- TKA candidacy
- Osteoarthritis
- Failure of non-operative treatments to control knee pain
- Patients able to understand and agree to study inclusion
Who cannot join
- Subjects have orthopaedic and medical co-morbidities that would thwart postoperative pain control such as extra-articular pathology with referred pain to the knee (spinal stenosis, neuropathy,ipsilateral hip disease)
- Severe knee deformity
- Post-traumatic and inflammatory arthritis
- BMI above 40
- Patients unable to receive multimodal pain remitting agents
- Active knee sepsis
Show all 16Show fewer
- Remote sites of active infection
- Diabetes with A1C > 7
- ASA class > lll
- Cardiac disease failing medical clearance
- Severe liver disease
- PAD with AAI < 0.75
- Seizure disorder
- Allergic to any pain remitting agent
- Alcohol abuse
- Smoking abuse
About this study
Official title: Bupivacaine Liposome Suspension Versus a Concentrated Multi Drug Periarticular Injection in 70 Patients Undergoing Total Knee Arthroplasty Without Femoral Nerve Block: a Double-blinded, Randomized Clinical Trial
Despite a robust multimodal pain management regimen, patients undergoing total knee arthroplasty (TKA) continue to report low satisfaction with postoperative pain management. Patient satisfaction further declines with any adverse event such as a drug reaction to neuroleptic medications or a patient fall due to a femoral nerve block. A new method of pain management throughout the hospital experience is warranted to improve patient satisfaction and the possibility of related adverse events. The purpose of this study is to examine if there is a difference in post operative pain and morphine (MSO4) total consumption for hospitalized TKA patients without femoral nerve block receiving an intra-operative periarticular injection of bupivacaine liposome suspension versus a concentrated multi drug.
Read the detailed description
The void in the literature is that while multimodal pain management reduces postoperative pain in the majority of TKA patients6-14, too many are still dissatisfied with overall pain control13 and adverse drug reactions (dizziness and somnolence) to neuroleptic medications15. Additionally, postoperative falls are greater with femoral nerve blocks16, and new neurological symptoms are associated with the block17. Bupivacaine liposome suspension periarticular injection has large scale national anecdotal support for TKA pain control with avoidance of regional block adversity. There is one recent randomized control trial in TKA patients favorably comparing periarticular injection with bupivacaine liposome suspension versus bupivacaine hydrochloride (HCL)5. To date the clinical use and published evidence most robustly supports bupivacaine liposome suspension in patients undergoing bunionectomy or hemorrhoidectomy. Additionally, in preparation for shorter hospital stays for total joint arthroplasty, a more effective and better tolerated pain management solution is needed.
Hypothesis Statement:
Hospitalized TKA patients without a pre-operative femoral nerve block will experience improved postoperative pain control and less MSO4 equivalence consumption when receiving an injection of bupivacaine liposome suspension versus concentrated multi drug.
- Conditions
- Total Knee Arthroplasty
- Being tested
- bupivacaine liposome suspension, concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaine liposome suspensionDrug
Also called Exparel
bupivacaine liposome suspension periarticular injection
concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCLDrug
Also called Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL
Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine liposome suspension | Experimental | bupivacaine liposome suspension periarticular injection Receives: Drug: bupivacaine liposome suspension |
| concentrated multi drug injection | Active comparator | concentrated multi drug periarticular injection Receives: Drug: concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores (Visual Analog Pain Scores)
visual analog pain scores (scale 0=no pain; 10=worst pain imaginable)
Measured: 1 day following surgery
Secondary outcomes (1)
MS04 Equivalent Consumption
in hospital total MS04 equivalent consumption
Measured: 1 day following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startAug 2013
- Primary completionDec 2013
- Study completionMar 2014
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 Total Knee ArthroplastyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299349
- Sponsor's protocol ID
- 13055-13-034
- Status last verified
- Mar 2017
- First submitted
- 17 Nov 2014
- Last updated
- 9 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bupivacaine Liposome Suspension Versus a Concentrated Multi Drug Periarticular Injection in 70 Patients Undergoing Total Knee Arthroplasty Without Femoral Nerve Block: a Double-blinded, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02299349
- Acronym / sponsor ID
- 13055-13-034
- Conditions
- Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Posted 15 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite a robust multimodal pain management regimen, patients undergoing total knee arthroplasty (TKA) continue to report low satisfaction with postoperative pain management. Patient satisfaction further declines with any adverse event such as a drug reaction to neuroleptic medications or a patient fall due to a femoral nerve block. A new method of pain management throughout the hospital experience is warranted to improve patient satisfaction and the possibility of related adverse events. The purpose of this study is to examine if there is a difference in post operative pain and morphine (MSO4) total consumption for hospitalized TKA patients without femoral nerve block receiving an intra-operative periarticular injection of bupivacaine liposome suspension versus a concentrated multi drug.
Detailed description
The void in the literature is that while multimodal pain management reduces postoperative pain in the majority of TKA patients6-14, too many are still dissatisfied with overall pain control13 and adverse drug reactions (dizziness and somnolence) to neuroleptic medications15. Additionally, postoperative falls are greater with femoral nerve blocks16, and new neurological symptoms are associated with the block17. Bupivacaine liposome suspension periarticular injection has large scale national anecdotal support for TKA pain control with avoidance of regional block adversity. There is one recent randomized control trial in TKA patients favorably comparing periarticular injection with bupivacaine liposome suspension versus bupivacaine hydrochloride (HCL)5. To date the clinical use and published evidence most robustly supports bupivacaine liposome suspension in patients undergoing bunionectomy or hemorrhoidectomy. Additionally, in preparation for shorter hospital stays for total joint arthroplasty, a more effective and better tolerated pain management solution is needed.
Hypothesis Statement:
Hospitalized TKA patients without a pre-operative femoral nerve block will experience improved postoperative pain control and less MSO4 equivalence consumption when receiving an injection of bupivacaine liposome suspension versus concentrated multi drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bupivacaine liposome suspension | Experimental | Drug: bupivacaine liposome suspensionbupivacaine liposome suspension periarticular injection |
| concentrated multi drug injection | Active comparator | Drug: concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCLconcentrated multi drug periarticular injection |
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- TKA candidacy
- Osteoarthritis
- Failure of non-operative treatments to control knee pain
- Patients able to understand and agree to study inclusion
Key exclusion criteria (16 listed)
- Subjects have orthopaedic and medical co-morbidities that would thwart postoperative pain control such as extra-articular pathology with referred pain to the knee (spinal stenosis, neuropathy,ipsilateral hip disease)
- Severe knee deformity
- Post-traumatic and inflammatory arthritis
- BMI above 40
- Patients unable to receive multimodal pain remitting agents
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 liposome suspensionAlso: Exparelbupivacaine liposome suspension periarticular injection | Drug | bupivacaine liposome suspension |
| concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCLAlso: Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCLKetorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl | Drug | concentrated multi drug injection |
Primary outcome
Pain Scores (Visual Analog Pain Scores)
Time frame: 1 day following surgery
visual analog pain scores (scale 0=no pain; 10=worst pain imaginable)
1 secondary outcome
MS04 Equivalent Consumption
Time frame: 1 day following surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing bupivacaine liposome suspension and concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL in people with Total Knee Arthroplasty, run by TriHealth Inc..
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 4 inclusion and 16 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 9 Oct 2018. 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?
Yes. Results are posted in the registry (first posted 15 Apr 2015). 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?
Pain Scores (Visual Analog Pain Scores) (time frame: 1 day following surgery). 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 9 Oct 2018.