Anesthesia, LocalNCT02626559
Serum Bupivacaine Concentration Levels After Injection of Liposomal Bupivacaine Into the Knee
An observational study of Anesthesia, Local, run by University of Utah at 1 site in United States.
Trial summary
Serum levels of bupivacaine over time after peri-articular injection of a mixture of liposomal bupivacaine and plain bupivacaine during total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- liposomal bupivacaine/plain bupivacaine peri-articular injection
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Nov 2016
- Phase
- Observational
- 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
Study population: Adults of at least 18 years of age having a primary, unilateral total knee arthroplasty with a surgical plan to have an intra-articular injection of a mixture of 266 mg of Exparel, 125 mg of bupivacaine, 1:300,000 epinephrine, and 0.9% saline to make a total volume of 100 ml.
Who may be able to join
- Adults of at least 18 years of age having a primary, unilateral total knee arthroplasty with a surgical plan to have an intra-articular injection of a mixture of 266 mg of Exparel, 125 mg of bupivacaine, 1:300,000 epinephrine, and 0.9% saline to make a total volume of 100 ml.
Who cannot join
- Known hepatic dysfunction or renal insufficiency (creatinine > 1.5 mg/dL);
- allergy to the study medications;
- pregnancy;
- incarceration;
- inability to communicate with the investigators;
- morbid obesity (body mass index > 40 kg/m2).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Bupivacaine Concentration Levels After Injection of the Knee Joint With a Mixture of Liposomal Bupivacaine and Free Bupivacaine During Total Knee Arthroplasty
Serum levels of bupivacaine over time after peri-articular injection of a mixture of liposomal bupivacaine and plain bupivacaine during total knee arthroplasty.
- Conditions
- Anesthesia, Local
- Being tested
- liposomal bupivacaine/plain bupivacaine peri-articular injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposomal bupivacaine/plain bupivacaine peri-articular injectionDrug
Injection of a mixture of liposomal and plain bupivacaine around the knee during total knee arthroplasty.
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Bupivacaine levels
Measured: 5 minutes to 24 hours after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2016
- Study completionNov 2016
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 Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Buys, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626559
- Sponsor's protocol ID
- IRB_00082660
- Status last verified
- Dec 2016
- First submitted
- 7 Dec 2015
- Last updated
- 9 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Buys MJ, Murphy MF, Warrick CM, Pace NL, Gililland JM, Pelt CE, Bankhead BR, Patzkowsky JL, Johnson KB. Serum Bupivacaine Concentration After Periarticular Injection With a Mixture of Liposomal Bupivacaine and Bupivacaine HCl During Total Knee Arthroplasty. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):582-587. doi: 10.1097/AAP.0000000000000636.
PubMed 28727583
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Bupivacaine Concentration Levels After Injection of the Knee Joint With a Mixture of Liposomal Bupivacaine and Free Bupivacaine During Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02626559
- Acronym / sponsor ID
- IRB_00082660
- Conditions
- Anesthesia, Local
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 10 Dec 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.
Serum levels of bupivacaine over time after peri-articular injection of a mixture of liposomal bupivacaine and plain bupivacaine during total knee arthroplasty.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults of at least 18 years of age having a primary, unilateral total knee arthroplasty with a surgical plan to have an intra-articular injection of a mixture of 266 mg of Exparel, 125 mg of bupivacaine, 1:300,000 epinephrine, and 0.9% saline to make a total volume of 100 ml.
Key inclusion criteria (1 listed)
- Adults of at least 18 years of age having a primary, unilateral total knee arthroplasty with a surgical plan to have an intra-articular injection of a mixture of 266 mg of Exparel, 125 mg of bupivacaine, 1:300,000 epinephrine, and 0.9% saline to make a total volume of 100 ml.
Key exclusion criteria (6 listed)
- Known hepatic dysfunction or renal insufficiency (creatinine > 1.5 mg/dL);
- allergy to the study medications;
- pregnancy;
- incarceration;
- inability to communicate with the investigators;
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/plain bupivacaine peri-articular injectionInjection of a mixture of liposomal and plain bupivacaine around the knee during total knee arthroplasty. | Drug | – |
Primary outcome
Serum Bupivacaine levels
Time frame: 5 minutes to 24 hours after injection
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 9 Dec 2016.
- Derived from this study: PubMed 28727583Buys MJ, Murphy MF, Warrick CM, Pace NL, Gililland JM, Pelt CE, Bankhead BR, Patzkowsky JL, Johnson KB. Serum Bupivacaine Concentration After Periarticular Injection With a Mixture of Liposomal Bupivacaine and Bupivacaine HCl During Total Knee Arthroplasty. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):582-587. doi: 10.1097/AAP.0000000000000636.
- Individual participant dataSharing planned: No
Related trials for Anesthesia, Local
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Recruiting
Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
Musculoskeletal Diseases or Conditions
RecruitingPhase 3
A Study of Changes to Prostate Procedures
Prostate Cancer
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, Local, run by University of Utah 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 1 inclusion and 6 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 Dec 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. 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?
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?
Serum Bupivacaine levels (time frame: 5 minutes to 24 hours after injection). 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 NCT02626559, 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 9 Dec 2016.