Knee Pain ArthritisNCT02276040
Serum Levels of Bupivacaine in Autotransfusion Drains Following Total Joint Arthroplasty
An observational study of Knee Pain Arthritis, run by OrthoCarolina Research Institute, Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to quantify the total blood serum levels of bupivacaine in OrthoPAT® collected blood 2 hours and 5 hours postoperatively. Hypothesis: Filtered blood from the OrthoPAT® autotransfusion system contains low or undetectable levels of bupivacaine hydrochloride (HCL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Pain Arthritis
- What is being tested?
- periarticular bupivicaine and liposomal bupivicaine
- Type of treatment
- Injection or infusion
- How many people
- 26 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2014to 30 Jun 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting for total knee replacement
Who may be able to join
- Patients undergoing primary total joint arthroplasty with use of periarticular bupivicaine and liposomal bupivicaine and OrthoPAT® auto reinfusion system.
- At least 18 years of age.
Who cannot join
- Allergy to bupivacaine.
- Allergy to epinephrine.
- Patients that are not presenting for a primary TJA
- Patients who are having a TJA without OrthoPAT® auto reinfusion system.
- Patients under age 18.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
OrthoCarolina, PA
Charlotte, North Carolina, 28207
Novant Health Charlotte Orthopedic Hospital
Charlotte, North Carolina, 28209
OrthoCarolina Research Institute, OrthoCarolina, P.A.
Charlotte, North Carolina, 28209
OrthoCarolina, PA
Charlotte, North Carolina, 28209
About this study
The purpose of this study is to quantify the total blood serum levels of bupivacaine in OrthoPAT® collected blood 2 hours and 5 hours postoperatively.
Hypothesis: Filtered blood from the OrthoPAT® autotransfusion system contains low or undetectable levels of bupivacaine hydrochloride (HCL). Reinfusion of collected blood from the OrthoPAT® device when used in conjunction with periarticular bupivicaine injections will not pose a bupivocaine toxicity risk to patients undergoing a total joint arthroplasty.
Read the detailed description
Total joint arthroplasty (TJA) is a commonly performed surgical procedure that can result in considerable postoperative pain which can limit social and functional recovery and a return to quality of life. Traditionally, pain control following TJA has been conducted with parenteral and oral narcotics. Recently, a number of studies have demonstrated the efficacy of multimodal analgesia following a variety of surgical procedures.1-2 These multimodal regimens vary and consist of any number of medications including narcotics, non-steroidal anti-inflammatories, anti-epileptics, and peripheral nerve blocks among others. These multimodal regimens have been associated with a reduction in the use of opioid analgesics, leading to fewer opioid-associated adverse events.3-5 One of the newest modalities introduced on the market is liposomal bupivacaine, trade name Exparel. The advertised advantage of liposomal bupivacaine compared with bupivacaine HCL is a longer duration of analgesia owing to gradual release from the liposomes. Liposomal bupivacaine is employed in a periarticular injection at the conclusion of TJAs to aid in post-operative pain control.
Patients receive a periarticular injection of liposomal bupivacaine intra-operatively during TJA. At the conclusion of the procedure, a specialized intra-articular drain (OrthoPAT®) is placed. The OrthoPAT® perioperative autotransfusion system collects the patient's blood in the immediate postoperative period and then allows for it to be transfused to the patient while on the floor.
A potential risk, although low, is the concern for bupivicaine toxicity. Toxicity from bupivicaine is associated with central nervous system issues (seizures) and cardiac toxicity. Toxicity is dose dependent and recommended levels should not exceed 400mg/24 hr period. With autotransfusion, there is a theoretical concern that blood, potentially with increased levels of bupivicaine, could be reinfused into the vascular system and create toxicity.
- Conditions
- Knee Pain Arthritis
- Being tested
- periarticular bupivicaine and liposomal bupivicaine
- Keywords
- Arthroplasty, Knee Replacement, Analgesia, pain
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periarticular bupivicaine and liposomal bupivicaineDrug
Also called Exparel
Participants will receive Exparel (liposomal bupivacaine). Exparel is a FDA approved product. Exparel is an extended-release formulation of bupivacaine consisting of microscopic lipid-based particles that diffuse over an extended period. The result is pain relief that can last up to 96 hours after surgery. Extended-release liposomal bupivacaine-based analgesics were shown to provide extended pain relief and decrease opioid (pain medication) use. At the conclusion of the total joint arthroplasty procedure, Exparel is administered via injection into the joint (periarticular bupivicaine and liposomal bupivicaine).
| Study group | Role | What they receive |
|---|---|---|
| Exparel | Participants will receive Exparel (periarticular bupivicaine and liposomal bupivicaine). Receives: Drug: periarticular bupivicaine and liposomal bupivicaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood Serum Levels of Bupivocaine From Baseline
Bupivocaine levels measured in the blood that is collected in a surgical drain post surgery. Blood samples will be tested for change in serum bupivicaine levels from baseline.
Measured: Change from baseline at 2 and 5 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2015
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee Pain ArthritisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrthoCarolina Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bryan Springer, MD, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276040
- Sponsor's protocol ID
- 09-14-13E-9084
- Status last verified
- Jul 2017
- First submitted
- 21 Oct 2014
- Last updated
- 30 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Levels of Bupivacaine in Autotransfusion Drains Following Total Joint Arthroplasty
- ClinicalTrials.gov ID
- NCT02276040
- Acronym / sponsor ID
- 09-14-13E-9084
- Conditions
- Knee Pain Arthritis
- Keywords
- Arthroplasty, Knee Replacement, Analgesia, pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- OrthoCarolina Research Institute, Inc.University, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 27 Oct 2014 (estimated)
- Results
- Posted 30 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to quantify the total blood serum levels of bupivacaine in OrthoPAT® collected blood 2 hours and 5 hours postoperatively.
Hypothesis: Filtered blood from the OrthoPAT® autotransfusion system contains low or undetectable levels of bupivacaine hydrochloride (HCL). Reinfusion of collected blood from the OrthoPAT® device when used in conjunction with periarticular bupivicaine injections will not pose a bupivocaine toxicity risk to patients undergoing a total joint arthroplasty.
Detailed description
Total joint arthroplasty (TJA) is a commonly performed surgical procedure that can result in considerable postoperative pain which can limit social and functional recovery and a return to quality of life. Traditionally, pain control following TJA has been conducted with parenteral and oral narcotics. Recently, a number of studies have demonstrated the efficacy of multimodal analgesia following a variety of surgical procedures.1-2 These multimodal regimens vary and consist of any number of medications including narcotics, non-steroidal anti-inflammatories, anti-epileptics, and peripheral nerve blocks among others. These multimodal regimens have been associated with a reduction in the use of opioid analgesics, leading to fewer opioid-associated adverse events.3-5 One of the newest modalities introduced on the market is liposomal bupivacaine, trade name Exparel. The advertised advantage of liposomal bupivacaine compared with bupivacaine HCL is a longer duration of analgesia owing to gradual release from the liposomes. Liposomal bupivacaine is employed in a periarticular injection at the conclusion of TJAs to aid in post-operative pain control.
Patients receive a periarticular injection of liposomal bupivacaine intra-operatively during TJA. At the conclusion of the procedure, a specialized intra-articular drain (OrthoPAT®) is placed. The OrthoPAT® perioperative autotransfusion system collects the patient's blood in the immediate postoperative period and then allows for it to be transfused to the patient while on the floor.
A potential risk, although low, is the concern for bupivicaine toxicity. Toxicity from bupivicaine is associated with central nervous system issues (seizures) and cardiac toxicity. Toxicity is dose dependent and recommended levels should not exceed 400mg/24 hr period. With autotransfusion, there is a theoretical concern that blood, potentially with increased levels of bupivicaine, could be reinfused into the vascular system and create toxicity.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exparel | – | Drug: periarticular bupivicaine and liposomal bupivicaineParticipants will receive Exparel (periarticular bupivicaine and liposomal bupivicaine). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting for total knee replacement
Key inclusion criteria (2 listed)
- Patients undergoing primary total joint arthroplasty with use of periarticular bupivicaine and liposomal bupivicaine and OrthoPAT® auto reinfusion system.
- At least 18 years of age.
Key exclusion criteria (5 listed)
- Allergy to bupivacaine.
- Allergy to epinephrine.
- Patients that are not presenting for a primary TJA
- Patients who are having a TJA without OrthoPAT® auto reinfusion system.
- Patients under age 18.
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 |
|---|---|---|
| periarticular bupivicaine and liposomal bupivicaineAlso: ExparelParticipants will receive Exparel (liposomal bupivacaine). Exparel is a FDA approved product. Exparel is an extended-release formulation of bupivacaine consisting of microscopic lipid-based particles that diffuse over an extended period. The result is pain relief that can last up to 96 hours after surgery. Extended-release liposomal bupivacaine-based analgesics were shown to provide extended pain relief and decrease opioid (pain medication) use. At the conclusion of the total joint arthroplasty procedure, Exparel is administered via injection into the joint (periarticular bupivicaine and liposomal bupivicaine). | Drug | Exparel |
Primary outcome
Change in Blood Serum Levels of Bupivocaine From Baseline
Time frame: Change from baseline at 2 and 5 hours post-dose
Bupivocaine levels measured in the blood that is collected in a surgical drain post surgery. Blood samples will be tested for change in serum bupivicaine levels from baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bryan Springer, MD principal investigator
Physician
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Pain Arthritis, run by OrthoCarolina Research Institute, Inc. at 4 sites 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 2 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: finished, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 30 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Blood Serum Levels of Bupivocaine From Baseline (time frame: Change from baseline at 2 and 5 hours post-dose). 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 30 Nov 2017.