Knee OsteoarthritisPhase 4NCT02365727
Exparel vs Exparel Plus ACB in TKAs
A Phase 4 study testing Liposomal bupivacaine, Ropivacaine and Epinephrine in people with Knee Osteoarthritis, run by The Hawkins Foundation at 1 site in United States.
Trial summary
Patients will be randomized (like the flip of a coin) to receive Exparel and a nerve block, standard of care for this procedure, or Exparel alone for pain management after surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Liposomal bupivacaine, Ropivacaine and Epinephrine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Aug 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18 to 80 years at the time of surgery.
- Willing and able to give voluntary informed consent to participate in this investigation.
- Candidate for total knee arthroplasty.
- BMI < 35.
Who cannot join
- Subject has had previous arthroplasty or fracture procedure(s) on the operative knee.
- Creatine level ≥ 1.5
- Pre-existing gait disturbance or neuropathy.
- Allergy to local anesthetics.
- Inflammatory arthropathies.
- Female patient who is pregnant or nursing.
- Chronic use of narcotics
- Any other reason (in the judgment of the investigator).
Trial locations and contacts
1 site in 1 country.
United States1 site
Steadman Hawkins Clinic of the Carolinas - Greenville Health System
Greenville, South Carolina, 29615
About this study
Official title: Two-arm, Double-blind Randomized Study Comparing Exparel and Exparel Plus an Adductor Canal Block in Total Knee Arthroplasty
Patients will be randomized (like the flip of a coin) to receive Exparel and a nerve block, standard of care for this procedure, or Exparel alone for pain management after surgery. They will also be asked to complete questionnaires before surgery, during their stay at the hospital after surgery, then at 3 months, 6 months and 12 months after surgery to assess pain and/or function levels, as well as the amount of pain medicine patients have used after surgery. Patients' leg strength will be measured immediately after surgery and again at 3, 6 and 12 months after surgery.
- Conditions
- Knee Osteoarthritis
- Being tested
- Liposomal bupivacaine, Ropivacaine, Epinephrine, Clonidine, Saline
- 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
RopivacaineDrug
EpinephrineDrug
ClonidineDrug
SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Exparel plus Adductor Canal Block | Experimental | Adductor canal block with 20 cc 0.5% Ropivacaine with 1:400,000 epinephrine and 100mcg of clonidine Receives: Drug: Liposomal bupivacaine; Drug: Ropivacaine; Drug: Epinephrine; Drug: Clonidine |
| Exparel plus Placebo Block | Placebo comparator | Adductor canal block with 20 cc saline Receives: Drug: Liposomal bupivacaine; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain as assessed by Visual Analog Scale (VAS)
Pain, as assessed by Visual Analog Scale (VAS)
Measured: 12 Months
Secondary outcomes (2)
Function as assessed by Knee Society Score (KSS) and EQ-5D
Function, as assessed by Knee Society Score (KSS) and EQ-5D
Measured: 12 Months
Opioid consumption as assessed by dosage and frequency of narcotic usage
Opioid consumption, as assessed by dosage and frequency of narcotic usage
Measured: 30 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startApr 2015
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Protocol not feasible as written
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hawkins Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brayton Shirley, Principal investigator, Steadman Hawkins Clinic of the Carolinas - Greenville Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365727
- Sponsor's protocol ID
- Pro00034356
- Status last verified
- Jan 2016
- First submitted
- 11 Feb 2015
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-arm, Double-blind Randomized Study Comparing Exparel and Exparel Plus an Adductor Canal Block in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02365727
- Acronym / sponsor ID
- Pro00034356
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Protocol not feasible as written
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Hawkins FoundationUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 19 Feb 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.
Patients will be randomized (like the flip of a coin) to receive Exparel and a nerve block, standard of care for this procedure, or Exparel alone for pain management after surgery. They will also be asked to complete questionnaires before surgery, during their stay at the hospital after surgery, then at 3 months, 6 months and 12 months after surgery to assess pain and/or function levels, as well as the amount of pain medicine patients have used after surgery. Patients' leg strength will be measured immediately after surgery and again at 3, 6 and 12 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exparel plus Adductor Canal Block | Experimental | Drug: Liposomal bupivacaine, Drug: Ropivacaine, Drug: Epinephrine, Drug: ClonidineAdductor canal block with 20 cc 0.5% Ropivacaine with 1:400,000 epinephrine and 100mcg of clonidine |
| Exparel plus Placebo Block | Placebo comparator | Drug: Liposomal bupivacaine, Drug: SalineAdductor canal block with 20 cc saline |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, aged 18 to 80 years at the time of surgery.
- Willing and able to give voluntary informed consent to participate in this investigation.
- Candidate for total knee arthroplasty.
- BMI < 35.
Key exclusion criteria (8 listed)
- Subject has had previous arthroplasty or fracture procedure(s) on the operative knee.
- Creatine level ≥ 1.5
- Pre-existing gait disturbance or neuropathy.
- Allergy to local anesthetics.
- Inflammatory arthropathies.
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 | Exparel plus Adductor Canal Block, Exparel plus Placebo Block |
| Ropivacaine | Drug | Exparel plus Adductor Canal Block |
| Epinephrine | Drug | Exparel plus Adductor Canal Block |
| Clonidine | Drug | Exparel plus Adductor Canal Block |
| Saline | Drug | Exparel plus Placebo Block |
Primary outcome
Pain as assessed by Visual Analog Scale (VAS)
Time frame: 12 Months
Pain, as assessed by Visual Analog Scale (VAS)
2 secondary outcomes
Function as assessed by Knee Society Score (KSS) and EQ-5D
Time frame: 12 Months
Opioid consumption as assessed by dosage and frequency of narcotic usage
Time frame: 30 hours
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 14 Jan 2016.
Related trials for Knee Osteoarthritis
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
A Study to Learn About Study Medicine Called Berobenatide in Adults With Knee Pain and Overweight or Obesity (VESPER-OA 1)
Obesity, Overweight
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
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.
Brayton Shirley principal investigator
Steadman Hawkins Clinic of the Carolinas - Greenville Health System
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, Ropivacaine and Epinephrine in people with Knee Osteoarthritis, run by The Hawkins Foundation 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 4 inclusion and 8 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 14 Jan 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. Some participants in this study may receive a placebo. 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?
Pain as assessed by Visual Analog Scale (VAS) (time frame: 12 Months). 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 Jan 2016.