Knee OsteoarthritisPhase 4NCT02863120
Liposomal Bupivacaine vs Adductor Canal Block in Total Knee Arthroplasty
A Phase 4 study testing liposomal bupivacaine, bupivacaine HCl and Ropivacaine in people with Knee Osteoarthritis, run by Texas Orthopaedics, Sports and Rehabilitation Associates at 1 site in United States.
Trial summary
This study is being done to evaluate the outcomes of patients undergoing total knee replacement with two different methods of local pain control:shots of liposomal bupivacaine, a long acting anesthetic, directly into the knee during surgery or anesthetic delivered continuously to the adductor canal to provide long… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- liposomal bupivacaine, bupivacaine HCl and Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Dec 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female between the ages of 18-65
- Patients willing and able to sign the informed consent
- Patients able to comply with follow-up requirements including self-evaluations
- Patients requiring a primary total knee replacement
- Patients with a diagnosis of osteoarthritis, traumatic arthritis, or avascular necrosis
Who cannot join
- Revision total knee arthroplasty
- Bilateral total knee arthroplasty
- Patients with inflammatory arthritis
- Patients with a body mass index (BMI) > 40
- Allergy to ropivacaine, bupivacaine, or other local anesthetic agents
- Current use of opioid drugs
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- Patients with a history of total or unicompartmental reconstruction of the affected joint
- Patients that have had a high tibial osteotomy or femoral osteotomy
- Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess pain levels
- Patients with a systemic or metabolic disorder leading to progressive bone deterioration
- Patients that are immunologically compromised, or receiving chronic steroids (>30 days), excluding inhalers
- Patients' bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis
- Patients with knee fusion to the affected joint
- Patients with an active or suspected latent infection in or about the knee joint
- Patients that are prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Outcomes With Periarticular Liposomal Bupivacaine Injection vs Adductor Canal Block After Primary Total Knee Arthroplasty
This study is being done to evaluate the outcomes of patients undergoing total knee replacement with two different methods of local pain control:shots of liposomal bupivacaine, a long acting anesthetic, directly into the knee during surgery or anesthetic delivered continuously to the adductor canal to provide long term pain relief. The goal is to try to find a standard protocol that provides the greatest pain relief for patients undergoing total knee replacement.
- Conditions
- Knee Osteoarthritis
- Being tested
- liposomal bupivacaine, bupivacaine HCl, Ropivacaine, Saline
- Keywords
- Bupivacaine, Osteoarthritis, Arthritis, Joint Diseases, Ropivacaine, Anesthetics, Local, Anesthetics
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Arthritis, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposomal bupivacaineDrug
Also called Exparel
bupivacaine HClDrug
Also called Marcaine
RopivacaineDrug
Also called Naropin
SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Liposomal bupivacaine | Active comparator | Periarticular infiltration of 20cc of liposomal bupivacaine with 10cc of normal saline and 30cc of bupivacaine HCl administered prior to cementation of knee implants Receives: Drug: liposomal bupivacaine; Drug: bupivacaine HCl; Drug: Saline |
| Adductor canal and tibial nerve block | Active comparator | Preoperative tibial nerve block with 15cc bupivacaine HCl and adductor canal block with 20cc adductor canal block. Postoperative continuous adductor canal block with 550cc ropivacaine at 8cc per hour Receives: Drug: bupivacaine HCl; Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay (LOS, in days)
Measured: Participants will be followed for the duration of their hospital stay, an expected average of 1.5 days
Time to ambulation (in hours)
Measured: 2-6 hours
Secondary outcomes (8)
Pain as assessed by visual analog scale (VAS) on postoperative day 0
Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5
Measured: 6 hours
Pain as assessed by visual analog scale (VAS) on postoperative day 1
Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5
Measured: 24 hours
Pain as assessed by visual analog scale (VAS) on postoperative day 2
Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5
Measured: 48 hours
Pain as assessed by visual analog scale (VAS) on postoperative day 3
Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5
Measured: 72 hours
Pain as assessed by visual analog scale (VAS) on postoperative day 4
Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5
Measured: 96 hours
Pain as assessed by visual analog scale (VAS) on postoperative day 5
Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5
Measured: 120 hours
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 1.5 days.
Postoperative complications and adverse events
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Orthopaedics, Sports and Rehabilitation Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tyler D Goldberg, MD, Principal investigator, Texas Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863120
- Sponsor's protocol ID
- TG-EXP-160402
- Status last verified
- Oct 2020
- First submitted
- 8 Aug 2016
- Last updated
- 8 Oct 2020
- 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 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Outcomes With Periarticular Liposomal Bupivacaine Injection vs Adductor Canal Block After Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02863120
- Acronym / sponsor ID
- TG-EXP-160402
- Conditions
- Knee Osteoarthritis
- Keywords
- Bupivacaine, Osteoarthritis, Arthritis, Joint Diseases, Ropivacaine, Anesthetics, Local, Anesthetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Texas Orthopaedics, Sports and Rehabilitation AssociatesUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 11 Aug 2016 (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.
This study is being done to evaluate the outcomes of patients undergoing total knee replacement with two different methods of local pain control:shots of liposomal bupivacaine, a long acting anesthetic, directly into the knee during surgery or anesthetic delivered continuously to the adductor canal to provide long term pain relief. The goal is to try to find a standard protocol that provides the greatest pain relief for patients undergoing total knee replacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal bupivacaine | Active comparator | Drug: liposomal bupivacaine, Drug: bupivacaine HCl, Drug: SalinePeriarticular infiltration of 20cc of liposomal bupivacaine with 10cc of normal saline and 30cc of bupivacaine HCl administered prior to cementation of knee implants |
| Adductor canal and tibial nerve block | Active comparator | Drug: bupivacaine HCl, Drug: RopivacainePreoperative tibial nerve block with 15cc bupivacaine HCl and adductor canal block with 20cc adductor canal block. Postoperative continuous adductor canal block with 550cc ropivacaine at 8cc per hour |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or non-pregnant female between the ages of 18-65
- Patients willing and able to sign the informed consent
- Patients able to comply with follow-up requirements including self-evaluations
- Patients requiring a primary total knee replacement
- Patients with a diagnosis of osteoarthritis, traumatic arthritis, or avascular necrosis
Key exclusion criteria (15 listed)
- Revision total knee arthroplasty
- Bilateral total knee arthroplasty
- Patients with inflammatory arthritis
- Patients with a body mass index (BMI) > 40
- Allergy to ropivacaine, bupivacaine, or other local anesthetic 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 |
|---|---|---|
| liposomal bupivacaineAlso: Exparel | Drug | Liposomal bupivacaine |
| bupivacaine HClAlso: Marcaine | Drug | Adductor canal and tibial nerve block, Liposomal bupivacaine |
| RopivacaineAlso: Naropin | Drug | Adductor canal and tibial nerve block |
| Saline | Drug | Liposomal bupivacaine |
Primary outcome
Length of stay (LOS, in days)
Time frame: Participants will be followed for the duration of their hospital stay, an expected average of 1.5 days
Time to ambulation (in hours)
Time frame: 2-6 hours
8 secondary outcomes
Pain as assessed by visual analog scale (VAS) on postoperative day 0
Time frame: 6 hours
Pain as assessed by visual analog scale (VAS) on postoperative day 1
Time frame: 24 hours
Pain as assessed by visual analog scale (VAS) on postoperative day 2
Time frame: 48 hours
Pain as assessed by visual analog scale (VAS) on postoperative day 3
Time frame: 72 hours
Pain as assessed by visual analog scale (VAS) on postoperative day 4
Time frame: 96 hours
Pain as assessed by visual analog scale (VAS) on postoperative day 5
Time frame: 120 hours
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 1.5 days.
Postoperative complications and adverse events
Time frame: 2 weeks
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 8 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Tyler D Goldberg, MD principal investigator
Texas Orthopedics
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, bupivacaine HCl and Ropivacaine in people with Knee Osteoarthritis, run by Texas Orthopaedics, Sports and Rehabilitation Associates 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 5 inclusion and 15 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 8 Oct 2020. 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 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?
Length of stay (LOS, in days) (time frame: Participants will be followed for the duration of their hospital stay, an expected average of 1.5 days). The study lists 2 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 8 Oct 2020.