Cardiothoracic SurgeryPhase 4EXPARELNCT04065919
Evaluation of Liposomal Bupivacaine Compared to Usual Care and Its Effects on Pain for Cardiac Surgery
A Phase 4 study testing Liposomal bupivacaine and 0.25% Bupivacaine with epinephrine in people with Cardiothoracic Surgery, run by Florida Heart and Lung Institute at 1 site in United States.
Trial summary
Evaluation of Liposomal Bupivacaine Compared to Usual Care and its Effect on Pain for Cardiac Surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiothoracic Surgery
- What is being tested?
- Liposomal bupivacaine and 0.25% Bupivacaine with epinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 30 Nov 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years old
- All open heart surgeries from September 1, 2019 - September 30, 2020
- Able to read, comprehend and sign the informed consent form
Who cannot join
- Pregnancy
- < 18 years old and prisoners
- Not able to sign informed consent, including patients with an (LAR) legally authorized representative
- Patients with chronic pain requiring scheduled narcotic use
- Stage 4 kidney disease, Child Pugh score suggestive of liver cirrhosis/ disease
- Recent MI within 7 days of scheduled Cardiac surgery
- Known allergy to Liposomal Bupivacaine or derivative of
- Have or is currently involved in a Research Study within 30 days of scheduled surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Heart and Lung Institute
Gainesville, Florida, 32605
About this study
Evaluation of Liposomal Bupivacaine Compared to Usual Care and its Effect on Pain for Cardiac Surgery
Read the detailed description
Current standard of care for pain management includes a multimodal approach of peristernal and fifth intercoastal infiltration with 0.25% bupivacaine with epinepherine combined with immediate post operative IV acetaminophen, followed by scheduled oral acetaminophen and supplemental IV and PO narcotics. This practice is beneficial since it controls most of the direct surgical site pain for at least 6 hours, however, after the local anesthetic dissipates, pain is usually managed with the use of opioids combined with scheduled oral acetaminophen.
Opioids are the most commonly used medications to control pain early after surgery because of their high potency. However, their undesirable effects and risk of dependence become limitations.
The Investigators believe Liposomal Bupivacaine would be beneficial in this population due to its quick onset of action and prolonged half-life associated with liposomal formulation ranging from 23.8 to 34.1 hours. The primary endpoint will be a 20% reduction in opioids use.
- Conditions
- Cardiothoracic Surgery
- Being tested
- Liposomal bupivacaine, 0.25% Bupivacaine with epinephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
Also called Exparel
20mL EXPAREL+40mL bupivacaine 0.25% infiltrated into 5th intercostal space
0.25% Bupivacaine with epinephrineDrug
0.25% Bupivacaine with epinephrine at 1cc/kg total dose infiltrated into 5th intercostal space
| Study group | Role | What they receive |
|---|---|---|
| Exparel | Active comparator | administration of liposomal bupivacaine 266mg/20mL+ 40 mL bupivacaine 0.25% bupivacaine
. Receives: Drug: Liposomal bupivacaine; Drug: 0.25% Bupivacaine with epinephrine |
| Standard of Therapy | Active comparator | administration of 0.25% bupivacaine with epinephrine at 1cc/kg total dose Receives: Drug: 0.25% Bupivacaine with epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
20% change in opioids use
Record daily narcotic use
Measured: From post operative day of cardiac surgery through length of hospital admission and through study completion, an average of one year.
Secondary outcomes (6)
Time to extubation
Record in 15 minutes intervals the time when the breathing tube is removed
Measured: Post operative day of surgery through study completion, an average of 1 year
Time to ICU
Record time in 15 minute intervals the length of time in ICU
Measured: Post operative day of surgery through study completion, an average of 1 year
Pain Scores on Post op day 2,3 and 4
Record pain scores using the Wong - Baker" FACES" Pain rating scale and /or CPOT Critical Care Pain Observation Tool. Collecting the Scale ratings of 4-10.*Face #4 Hurts a Little, Face#6 Hurts Even More, Face #8 Hurts a Whole Lot Face#10 Hurts Worst. CPOT- Critical Care Pain Observational Tool Documenting Pain Intensity, Pain Location, Pain Radiation and Pain Description.
Measured: Post operative day of cardiac surgery through Post operative Day 4
Total narcotic use on Post op Day 2,3, and 4
Record daily narcotic use both Oral and Intravenous administration
Measured: Day of cardiac surgery to Post op day 4
Time to Hospital Discharge
Record the number of days(LOS) length of stay in the hospital from post operative surgery to discharge
Measured: Count the number of days from admission for cardiac surgery to day of hospital discharge through study completion , an average of one year
Major Adverse Cardiac Effects of Liposomal Bupivacaine
Record Major Adverse Cardiac Effects associated with Liposomal Bupivacaine, Arrythmias, Hypotension > 90/50,AV Block and Cardiac Arrest
Measured: Time of peristernal and fifth intercostal infiltration of liposomal bupivacaine through the expected half life associated with liposomal formulation ranging from 23.8 up to 34.1 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start1 Oct 2019
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiothoracic SurgeryStudies 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
- Model description
- Study comparing current standard of therapy using 0.25% bupivacaine with epinepherine at 1cc/kg total dose and the addition of liposomal bupivacaine 266mg/20ml for pain management in cardiac surgery. Patient and Investigator are blinded.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida Heart and Lung Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Klodell, MD, Florida Heart and Lung Institute
- Investigators
- Charles T Klodell, MD, Principal investigator, Florida Heart and Lung Institute, HCA Physician Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065919
- Sponsor's protocol ID
- IIT#2018-137
- Acronym
- EXPAREL
- Status last verified
- Feb 2020
- First submitted
- 2 Aug 2019
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Liposomal Bupivacaine Compared to Usual Care and Its Effects on Pain for Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04065919
- Acronym / sponsor ID
- EXPAREL / IIT#2018-137
- Conditions
- Cardiothoracic Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Florida Heart and Lung InstituteUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 22 Aug 2019 (actual)
- 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.
Evaluation of Liposomal Bupivacaine Compared to Usual Care and its Effect on Pain for Cardiac Surgery
Detailed description
Current standard of care for pain management includes a multimodal approach of peristernal and fifth intercoastal infiltration with 0.25% bupivacaine with epinepherine combined with immediate post operative IV acetaminophen, followed by scheduled oral acetaminophen and supplemental IV and PO narcotics. This practice is beneficial since it controls most of the direct surgical site pain for at least 6 hours, however, after the local anesthetic dissipates, pain is usually managed with the use of opioids combined with scheduled oral acetaminophen.
Opioids are the most commonly used medications to control pain early after surgery because of their high potency. However, their undesirable effects and risk of dependence become limitations.
The Investigators believe Liposomal Bupivacaine would be beneficial in this population due to its quick onset of action and prolonged half-life associated with liposomal formulation ranging from 23.8 to 34.1 hours. The primary endpoint will be a 20% reduction in opioids use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Study comparing current standard of therapy using 0.25% bupivacaine with epinepherine at 1cc/kg total dose and the addition of liposomal bupivacaine 266mg/20ml for pain management in cardiac surgery. Patient and Investigator are blinded.
| Arm | Type | Receives |
|---|---|---|
| Exparel | Active comparator | Drug: Liposomal bupivacaine, Drug: 0.25% Bupivacaine with epinephrineadministration of liposomal bupivacaine 266mg/20mL+ 40 mL bupivacaine 0.25% bupivacaine . |
| Standard of Therapy | Active comparator | Drug: 0.25% Bupivacaine with epinephrineadministration of 0.25% bupivacaine with epinephrine at 1cc/kg total dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years old
- All open heart surgeries from September 1, 2019 - September 30, 2020
- Able to read, comprehend and sign the informed consent form
Key exclusion criteria (8 listed)
- Pregnancy
- < 18 years old and prisoners
- Not able to sign informed consent, including patients with an (LAR) legally authorized representative
- Patients with chronic pain requiring scheduled narcotic use
- Stage 4 kidney disease, Child Pugh score suggestive of liver cirrhosis/ disease
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: Exparel20mL EXPAREL+40mL bupivacaine 0.25% infiltrated into 5th intercostal space | Drug | Exparel |
| 0.25% Bupivacaine with epinephrine0.25% Bupivacaine with epinephrine at 1cc/kg total dose infiltrated into 5th intercostal space | Drug | Exparel, Standard of Therapy |
Primary outcome
20% change in opioids use
Time frame: From post operative day of cardiac surgery through length of hospital admission and through study completion, an average of one year.
Record daily narcotic use
6 secondary outcomes
Time to extubation
Time frame: Post operative day of surgery through study completion, an average of 1 year
Time to ICU
Time frame: Post operative day of surgery through study completion, an average of 1 year
Pain Scores on Post op day 2,3 and 4
Time frame: Post operative day of cardiac surgery through Post operative Day 4
Total narcotic use on Post op Day 2,3, and 4
Time frame: Day of cardiac surgery to Post op day 4
Time to Hospital Discharge
Time frame: Count the number of days from admission for cardiac surgery to day of hospital discharge through study completion , an average of one year
Major Adverse Cardiac Effects of Liposomal Bupivacaine
Time frame: Time of peristernal and fifth intercostal infiltration of liposomal bupivacaine through the expected half life associated with liposomal formulation ranging from 23.8 up to 34.1 hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Cardiothoracic Surgery
RecruitingObservational study
Predictive Value of Modified Caprini Score and D-Dimer in Managing Lower Limb Venous Thrombosis in Cardiothoracic Patients
DVT - Deep Vein Thrombosis
RecruitingObservational study
Factors Affect Outcomes in Cardiovascular Surgery
Coronary Artery Disease, Valvular Diseases
RecruitingObservational study
Urine Output Response to Fluid and Diuretic Therapy in Cardiac ICU Patients Monitored With FIZE kUO®
AKI - Acute Kidney Injury, Cardiac Surgery
RecruitingObservational study
A Multicenter Patient Registry on Outcomes From Cryoanalgesia of the Intercostal Nerves
Post Operative Pain
Recruiting
Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes
Renal Impairment After Cardiac Surgery, Renal Impairment
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.
Charles T Klodell, MD principal investigator
Florida Heart and Lung Institute, HCA Physician Services
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 and 0.25% Bupivacaine with epinephrine in people with Cardiothoracic Surgery, run by Florida Heart and Lung Institute 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 3 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: status not confirmed, as of the sponsor's last update on 6 Feb 2020. 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?
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?
20% change in opioids use (time frame: From post operative day of cardiac surgery through length of hospital admission and through study completion, an average of one year.). 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 6 Feb 2020.