OsteoarthritisPhase 4NCT02808728
Effectiveness of Intraoperative Exparel for Postoperative Pain Control in Total Knee Arthroplasty
A Phase 4 study testing Pain Cocktail with Exparel and Pain Cocktail with Ropivacaine in people with Osteoarthritis and Total Knee Arthroplasty, run by DeClaire LaMacchia Orthopaedic Institute.
Trial summary
Does the use of periarticular Exparel in total knee arthroplasty prove to more effectively manage post operative pain control than another local analgesic, Ropivacaine, when both are used as part of a multimodal pain management approach? The investigators hypothesize that Exparel, a bupivacaine liposomal injectable… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Total Knee Arthroplasty, Pain Management
- What is being tested?
- Pain Cocktail with Exparel and Pain Cocktail with Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Jun 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient undergoing Total Knee Arthroplasty with Dr. J.H. DeClaire
- 18 years of age or older
- Primary diagnosis of osteoarthritis of the knee
- Opioid naïve patient (according to FDA guidelines)
Who cannot join
- Prior knee replacement
- Prior use of narcotics for chronic pain management
- Inflammatory arthritis (Rheumatoid arthritis, Lupus, etc.)
- Unicompartmental knee replacement
- Bilateral Total Knee Arthroplasty
- Opioid Tolerant as defined by the FDA: Patients who are taking, for one week or longer, at least:
- > 60 mg oral morphine/day > 25μg transdermal fentanyl/hour > 30 mg oral oxycodone/day > 8 mg oral hydromorphone/day > 25 mg oral oxymorphone/day
About this study
Official title: Effectiveness of Intraoperative Exparel, a Bupivacaine Liposome Injectable Suspension, for Postoperative Pain Control in Total Knee Arthroplasty: A Prospective, Randomized, Double Blind, Controlled Study
Does the use of periarticular Exparel in total knee arthroplasty prove to more effectively manage post operative pain control than another local analgesic, Ropivacaine, when both are used as part of a multimodal pain management approach?
The investigators hypothesize that Exparel, a bupivacaine liposomal injectable suspension, will improve total knee arthroplasty postoperative pain with significant improvement of early function outcomes.
Read the detailed description
The investigators use a double blind, controlled, randomized study to examine the effectiveness of periarticular Exparel in total knee arthroplasty postoperative pain control as well as effect on early mobilization and length of hospital stay when compared to another local analgesic (Ropivacaine) when both are used as part of a multimodal pain management approach.
- Conditions
- Osteoarthritis, Total Knee Arthroplasty, Pain Management
- Being tested
- Pain Cocktail with Exparel, Pain Cocktail with Ropivacaine
- Keywords
- Total Knee Arthroplasty, Total Knee Replacement, Exparel, Liposomal Bupivacaine, Ropivacaine, Postoperative Pain Management
- Medical subject headings
- Osteoarthritis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Cocktail with ExparelDrug
Also called liposomal bupivacaine
pain cocktail: bupivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 80cc preparation as well as an injection of Exparel (bupivacaine liposome injectable suspension), 20cc of 1.3% Exparel, to total 100cc.
Pain Cocktail with RopivacaineDrug
pain cocktail: ropivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 100cc preparation.
| Study group | Role | What they receive |
|---|---|---|
| Pain Cocktail with Ropivacaine | Active comparator | patients given the standard intra-articular "pain cocktail" injection, consisting of ropivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 100cc preparation.
given in one single dose Receives: Drug: Pain Cocktail with Ropivacaine |
| Pain Cocktail with Exparel | Experimental | patients given a similar intra-articular injection consisting of bupivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 80cc preparation as well as an injection of Exparel, 20cc of 1.3% Exparel, to total 100cc.
given in one single dose Receives: Drug: Pain Cocktail with Exparel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
oral and intravenous narcotic consumption is recorded during hospital stay
Measured: immediately post-operatively through hospital stay
Secondary outcomes (4)
Hours to ambulate 100 feet
Measured: immediately post-operatively through hospital stay
Length of hospital stay (hours)
Number of hours the patient stays at the hospital following operation
Measured: immediately post-operatively through hospital stay
Visual Analog Pain Score
Measured: day 1 and day 2 after operation, 3 months, 6 months, and 1 year operatively
Knee Society Score
Measured: 3 months, 6 months, 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startMay 2014
- Primary completionMar 2015
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- DeClaire LaMacchia Orthopaedic Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olayinka Warritay, MD, Study director, DeClaire LaMacchia Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808728
- Sponsor's protocol ID
- WIRB 20131914
- Status last verified
- Jun 2016
- First submitted
- 14 Jun 2016
- Last updated
- 22 Jun 2016
- Results posted
- No
Publications
DeClaire JH, Aiello PM, Warritay OK, Freeman DC. Effectiveness of Bupivacaine Liposome Injectable Suspension for Postoperative Pain Control in Total Knee Arthroplasty: A Prospective, Randomized, Double Blind, Controlled Study. J Arthroplasty. 2017 Sep;32(9S):S268-S271. doi: 10.1016/j.arth.2017.03.062. Epub 2017 Apr 6.
PubMed 28478185
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intraoperative Exparel, a Bupivacaine Liposome Injectable Suspension, for Postoperative Pain Control in Total Knee Arthroplasty: A Prospective, Randomized, Double Blind, Controlled Study
- ClinicalTrials.gov ID
- NCT02808728
- Acronym / sponsor ID
- WIRB 20131914
- Conditions
- Osteoarthritis, Total Knee Arthroplasty, Pain Management
- Keywords
- Total Knee Arthroplasty, Total Knee Replacement, Exparel, Liposomal Bupivacaine, Ropivacaine, Postoperative Pain Management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- DeClaire LaMacchia Orthopaedic InstituteUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2016 (estimated)
- First posted
- 22 Jun 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.
Does the use of periarticular Exparel in total knee arthroplasty prove to more effectively manage post operative pain control than another local analgesic, Ropivacaine, when both are used as part of a multimodal pain management approach?
The investigators hypothesize that Exparel, a bupivacaine liposomal injectable suspension, will improve total knee arthroplasty postoperative pain with significant improvement of early function outcomes.
Detailed description
The investigators use a double blind, controlled, randomized study to examine the effectiveness of periarticular Exparel in total knee arthroplasty postoperative pain control as well as effect on early mobilization and length of hospital stay when compared to another local analgesic (Ropivacaine) when both are used as part of a multimodal pain management approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain Cocktail with Ropivacaine | Active comparator | Drug: Pain Cocktail with Ropivacainepatients given the standard intra-articular "pain cocktail" injection, consisting of ropivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 100cc preparation. given in one single dose |
| Pain Cocktail with Exparel | Experimental | Drug: Pain Cocktail with Exparelpatients given a similar intra-articular injection consisting of bupivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 80cc preparation as well as an injection of Exparel, 20cc of 1.3% Exparel, to total 100cc. given in one single dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient undergoing Total Knee Arthroplasty with Dr. J.H. DeClaire
- 18 years of age or older
- Primary diagnosis of osteoarthritis of the knee
- Opioid naïve patient (according to FDA guidelines)
Key exclusion criteria (7 listed)
- Prior knee replacement
- Prior use of narcotics for chronic pain management
- Inflammatory arthritis (Rheumatoid arthritis, Lupus, etc.)
- Unicompartmental knee replacement
- Bilateral Total Knee Arthroplasty
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 |
|---|---|---|
| Pain Cocktail with ExparelAlso: liposomal bupivacainepain cocktail: bupivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 80cc preparation as well as an injection of Exparel (bupivacaine liposome injectable suspension), 20cc of 1.3% Exparel, to total 100cc. | Drug | Pain Cocktail with Exparel |
| Pain Cocktail with Ropivacainepain cocktail: ropivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 100cc preparation. | Drug | Pain Cocktail with Ropivacaine |
Primary outcome
Postoperative opioid consumption
Time frame: immediately post-operatively through hospital stay
oral and intravenous narcotic consumption is recorded during hospital stay
4 secondary outcomes
Hours to ambulate 100 feet
Time frame: immediately post-operatively through hospital stay
Length of hospital stay (hours)
Time frame: immediately post-operatively through hospital stay
Visual Analog Pain Score
Time frame: day 1 and day 2 after operation, 3 months, 6 months, and 1 year operatively
Knee Society Score
Time frame: 3 months, 6 months, 1 year postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
- Derived from this study: PubMed 28478185DeClaire JH, Aiello PM, Warritay OK, Freeman DC. Effectiveness of Bupivacaine Liposome Injectable Suspension for Postoperative Pain Control in Total Knee Arthroplasty: A Prospective, Randomized, Double Blind, Controlled Study. J Arthroplasty. 2017 Sep;32(9S):S268-S271. doi: 10.1016/j.arth.2017.03.062. Epub 2017 Apr 6.
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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.
Olayinka Warritay, MD study director
DeClaire LaMacchia Orthopaedic Institute
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pain Cocktail with Exparel and Pain Cocktail with Ropivacaine in people with Osteoarthritis and Total Knee Arthroplasty, run by DeClaire LaMacchia Orthopaedic Institute.
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 7 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: status not confirmed, as of the sponsor's last update on 22 Jun 2016. 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.
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?
Results are not available in the source record.
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?
Postoperative opioid consumption (time frame: immediately post-operatively through hospital stay). 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 NCT02808728, which also lists 1 linked publication.
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 Jun 2016.