Osteoarthritis, KneePhase 4NCT02765815
A Comparison of Exparel Local Anesthetic in Total Knee Arthroplasty (TKA) Patients
A Phase 4 study testing Liposomal bupivacaine, 266mg, Bupivacaine 0.5 % with Epinephrine and Ketorolac 30mg in people with Osteoarthritis, Knee and Arthroplasty, Replacement, Knee, run by Holy Cross Hospital, Florida at 1 site in United States.
Trial summary
This is a prospective, single-center, single-blinded, randomized, case-control study. The study is conducted by a single investigator at an orthopedic surgery institute, with a minimum 6 week post operative follow-up period of TKA patients who receive Exparel compared with the surgeon's standard method (detailed… Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Osteoarthritis, Knee, Arthroplasty, Replacement, Knee
- What is being tested?
- Liposomal bupivacaine, 266mg, Bupivacaine 0.5 % with Epinephrine and Ketorolac 30mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Jan 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 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 88 years of age.
- Subject is scheduled to undergo primary unilateral Total Knee Arthroplasty.
- Subject willing and able to sign the informed consent.
- Subject is fluent in verbal and written English.
- Subject agrees to take Liposomal bupivacaine or standard of care equivalent.
Who cannot join
- Previous Partial or Total Knee Arthroplasty of the study knee. Previous Non-Implant surgery on the study knee and contralateral knee is permitted.
- Subject is pregnant or planning to become pregnant while enrolled in the study.
- Subject has a history of narcotic or alcohol abuse.
- Subjects with hepatic disease or renal impairment (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 x upper limit of normal or estimated glomerular filtration rate (eGFR) < 30 ml/min within 30 days of surgery).
- For any reason, in the opinion of the investigator, the Subject may not be a suitable candidate for study participation (i.e., history of noncompliance, drug dependency, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Holy Cross Hospital Orthopedic Research Institute
Fort Lauderdale, Florida, 33334
About this study
Official title: A Prospective Randomized Case Series Comparison on the Clinical Efficacy of Exparel Local Anesthetic in Total Knee Arthroplasty Patients
This is a prospective, single-center, single-blinded, randomized, case-control study. The study is conducted by a single investigator at an orthopedic surgery institute, with a minimum 6 week post operative follow-up period of TKA patients who receive Exparel compared with the surgeon's standard method (detailed below) for pain management intraoperatively.
Read the detailed description
This is a prospective, single-center, single-blinded, randomized, case-control study. The study is conducted by a single investigator at an orthopedic surgery institute, with a minimum 6 week post operative follow-up period. Subjects scheduled for a planned total knee arthroplasty procedure will be consented and those meeting study criteria will be randomized to receive intra-operative injections at the surgical site of liposomal bupivicaine plus a multi-drug cocktail, or a multi-drug cocktail alone.
This study will recruit subjects on an ongoing basis with a minimum of 130 study participants and a maximum of 156. Efficacy data on surgical pain control and safety data will be collected at frequent intervals during the hospitalization. Each study participant will be followed for a minimum 6 week follow-up period.
- Being tested
- Liposomal bupivacaine, 266mg, Bupivacaine 0.5 % with Epinephrine, Ketorolac 30mg, Morphine 10mg, Bupivacaine 0.25% with Epinephrine
- Keywords
- TKA, Knee replacement, Arthritis, Knee
- Medical subject headings
- Osteoarthritis, Knee, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaine, 266mgDrug
Also called Exparel Injection
Bupivacaine 0.5 % with EpinephrineDrug
Ketorolac 30mgDrug
Morphine 10mgDrug
Bupivacaine 0.25% with EpinephrineDrug
| Study group | Role | What they receive |
|---|---|---|
| Exparel plus multi-drug cocktail | Active comparator | Liposomal bupivacaine, 266mg plus Bupivacaine 0.25% with Epinephrine, Ketorolac 30mg, and Morphine 10mg. Receives: Drug: Liposomal bupivacaine, 266mg; Drug: Ketorolac 30mg; Drug: Morphine 10mg; Drug: Bupivacaine 0.25% with Epinephrine |
| Multi-drug cocktail alone | Active comparator | Bupivacaine 0.5% with Epinephrine, Ketorolac 30mg, Morphine 10mg. Receives: Drug: Bupivacaine 0.5 % with Epinephrine; Drug: Ketorolac 30mg; Drug: Morphine 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported Visual Analog Scale (VAS) pain intensity score. Post-surgery hours 4-24.
The area under the curve (AUC) of the VAS scores from 4-24 hours will be compared between the two treatment groups.
Measured: VAS pain intensity scores will be collected starting four hours after end of surgery and every 4 hours thereafter until hour 24.
Patient reported VAS pain intensity score. Post-surgery hours 24-48.
The AUC of the VAS scores from 24-48 hours or until discharge will be compared between the two treatment groups.
Measured: VAS pain intensity scores will be collected starting 24 hours after end of surgery and every 4 hours thereafter until hour 48, or discharge.
Patient reported VAS pain intensity score. Post-surgery hours 48-72.
The AUC of the VAS scores from 48-72 hours or until discharge will be compared between the two treatment groups.
Measured: VAS pain intensity scores will be collected starting 48 hours after end of surgery and every 4 hours thereafter until hour 72, or discharge.
Secondary outcomes (1)
Cost:benefit analysis
Correlation between hospital charges and improvement in VAS pain intensity score from baseline to the 2-week and 6-week follow-up time points.
Measured: TKA hospitalization charges, and VAS pain intensity scores pre-operative on day of surgery, 2-week and 6-week followup visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study startFeb 2016 (estimated)
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: competing protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holy Cross Hospital, Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Roche, MD, Principal investigator, Holy Cross Orthopedic Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765815
- Sponsor's protocol ID
- Exparel TKA
- Status last verified
- Aug 2017
- First submitted
- 27 Jan 2016
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
PubMed 17403800Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.
PubMed 10422923Fetherston CM, Ward S. Relationships between post operative pain management and short term functional mobility in total knee arthroplasty patients with a femoral nerve catheter: a preliminary study. J Orthop Surg Res. 2011 Feb 7;6:7. doi: 10.1186/1749-799X-6-7.
PubMed 21294923American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.
PubMed 22227789Bagsby DT, Ireland PH, Meneghini RM. Liposomal bupivacaine versus traditional periarticular injection for pain control after total knee arthroplasty. J Arthroplasty. 2014 Aug;29(8):1687-90. doi: 10.1016/j.arth.2014.03.034. Epub 2014 Apr 4.
PubMed 24793570Broome CB, Burnikel B. Novel strategies to improve early outcomes following total knee arthroplasty: a case control study of intra articular injection versus femoral nerve block. Int Orthop. 2014 Oct;38(10):2087-9. doi: 10.1007/s00264-014-2392-0. Epub 2014 Jun 18.
PubMed 24938586Bramlett K, Onel E, Viscusi ER, Jones K. A randomized, double-blind, dose-ranging study comparing wound infiltration of DepoFoam bupivacaine, an extended-release liposomal bupivacaine, to bupivacaine HCl for postsurgical analgesia in total knee arthroplasty. Knee. 2012 Oct;19(5):530-6. doi: 10.1016/j.knee.2011.12.004. Epub 2012 Jan 28.
PubMed 22285545
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Case Series Comparison on the Clinical Efficacy of Exparel Local Anesthetic in Total Knee Arthroplasty Patients
- ClinicalTrials.gov ID
- NCT02765815
- Acronym / sponsor ID
- Exparel TKA
- Keywords
- TKA, Knee replacement, Arthritis, Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: competing protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Holy Cross Hospital, FloridaUniversity, hospital or other
- Study start
- Feb 2016 (estimated)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 9 May 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 is a prospective, single-center, single-blinded, randomized, case-control study. The study is conducted by a single investigator at an orthopedic surgery institute, with a minimum 6 week post operative follow-up period of TKA patients who receive Exparel compared with the surgeon's standard method (detailed below) for pain management intraoperatively.
Detailed description
This is a prospective, single-center, single-blinded, randomized, case-control study. The study is conducted by a single investigator at an orthopedic surgery institute, with a minimum 6 week post operative follow-up period. Subjects scheduled for a planned total knee arthroplasty procedure will be consented and those meeting study criteria will be randomized to receive intra-operative injections at the surgical site of liposomal bupivicaine plus a multi-drug cocktail, or a multi-drug cocktail alone.
This study will recruit subjects on an ongoing basis with a minimum of 130 study participants and a maximum of 156. Efficacy data on surgical pain control and safety data will be collected at frequent intervals during the hospitalization. Each study participant will be followed for a minimum 6 week follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exparel plus multi-drug cocktail | Active comparator | Drug: Liposomal bupivacaine, 266mg, Drug: Ketorolac 30mg, Drug: Morphine 10mg, Drug: Bupivacaine 0.25% with EpinephrineLiposomal bupivacaine, 266mg plus Bupivacaine 0.25% with Epinephrine, Ketorolac 30mg, and Morphine 10mg. |
| Multi-drug cocktail alone | Active comparator | Drug: Bupivacaine 0.5 % with Epinephrine, Drug: Ketorolac 30mg, Drug: Morphine 10mgBupivacaine 0.5% with Epinephrine, Ketorolac 30mg, Morphine 10mg. |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 to 88 years of age.
- Subject is scheduled to undergo primary unilateral Total Knee Arthroplasty.
- Subject willing and able to sign the informed consent.
- Subject is fluent in verbal and written English.
- Subject agrees to take Liposomal bupivacaine or standard of care equivalent.
Key exclusion criteria (5 listed)
- Previous Partial or Total Knee Arthroplasty of the study knee. Previous Non-Implant surgery on the study knee and contralateral knee is permitted.
- Subject is pregnant or planning to become pregnant while enrolled in the study.
- Subject has a history of narcotic or alcohol abuse.
- Subjects with hepatic disease or renal impairment (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 x upper limit of normal or estimated glomerular filtration rate (eGFR) < 30 ml/min within 30 days of surgery).
- For any reason, in the opinion of the investigator, the Subject may not be a suitable candidate for study participation (i.e., history of noncompliance, drug dependency, etc.)
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 bupivacaine, 266mgAlso: Exparel Injection | Drug | Exparel plus multi-drug cocktail |
| Bupivacaine 0.5 % with Epinephrine | Drug | Multi-drug cocktail alone |
| Ketorolac 30mg | Drug | Exparel plus multi-drug cocktail, Multi-drug cocktail alone |
| Morphine 10mg | Drug | Exparel plus multi-drug cocktail, Multi-drug cocktail alone |
| Bupivacaine 0.25% with Epinephrine | Drug | Exparel plus multi-drug cocktail |
Primary outcome
Patient reported Visual Analog Scale (VAS) pain intensity score. Post-surgery hours 4-24.
Time frame: VAS pain intensity scores will be collected starting four hours after end of surgery and every 4 hours thereafter until hour 24.
The area under the curve (AUC) of the VAS scores from 4-24 hours will be compared between the two treatment groups.
Patient reported VAS pain intensity score. Post-surgery hours 24-48.
Time frame: VAS pain intensity scores will be collected starting 24 hours after end of surgery and every 4 hours thereafter until hour 48, or discharge.
The AUC of the VAS scores from 24-48 hours or until discharge will be compared between the two treatment groups.
Patient reported VAS pain intensity score. Post-surgery hours 48-72.
Time frame: VAS pain intensity scores will be collected starting 48 hours after end of surgery and every 4 hours thereafter until hour 72, or discharge.
The AUC of the VAS scores from 48-72 hours or until discharge will be compared between the two treatment groups.
1 secondary outcome
Cost:benefit analysis
Time frame: TKA hospitalization charges, and VAS pain intensity scores pre-operative on day of surgery, 2-week and 6-week followup visits.
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 9 Aug 2017.
- Results publication: PubMed 17403800Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
- Results publication: PubMed 10422923Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.
- Results publication: PubMed 21294923Fetherston CM, Ward S. Relationships between post operative pain management and short term functional mobility in total knee arthroplasty patients with a femoral nerve catheter: a preliminary study. J Orthop Surg Res. 2011 Feb 7;6:7. doi: 10.1186/1749-799X-6-7.
- Results publication: PubMed 22227789American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.
- Results publication: PubMed 24793570Bagsby DT, Ireland PH, Meneghini RM. Liposomal bupivacaine versus traditional periarticular injection for pain control after total knee arthroplasty. J Arthroplasty. 2014 Aug;29(8):1687-90. doi: 10.1016/j.arth.2014.03.034. Epub 2014 Apr 4.
- Results publication: PubMed 24938586Broome CB, Burnikel B. Novel strategies to improve early outcomes following total knee arthroplasty: a case control study of intra articular injection versus femoral nerve block. Int Orthop. 2014 Oct;38(10):2087-9. doi: 10.1007/s00264-014-2392-0. Epub 2014 Jun 18.
- Results publication: PubMed 22285545Bramlett K, Onel E, Viscusi ER, Jones K. A randomized, double-blind, dose-ranging study comparing wound infiltration of DepoFoam bupivacaine, an extended-release liposomal bupivacaine, to bupivacaine HCl for postsurgical analgesia in total knee arthroplasty. Knee. 2012 Oct;19(5):530-6. doi: 10.1016/j.knee.2011.12.004. Epub 2012 Jan 28.
- 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.
Martin Roche, MD principal investigator
Holy Cross Orthopedic Research Institute
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, 266mg, Bupivacaine 0.5 % with Epinephrine and Ketorolac 30mg in people with Osteoarthritis, Knee and Arthroplasty, Replacement, Knee, run by Holy Cross Hospital, Florida 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 5 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 9 Aug 2017. 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?
Patient reported Visual Analog Scale (VAS) pain intensity score. Post-surgery hours 4-24. (time frame: VAS pain intensity scores will be collected starting four hours after end of surgery and every 4 hours thereafter until hour 24.). The study lists 3 primary outcomes in all. 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 NCT02765815, which also lists 7 linked publications.
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 Aug 2017.