Cardiac DiseasePhase 4NCT02008370
Exparel in Minimally Invasive Cardiac Surgery
A Phase 4 study testing Exparel infiltration in people with Cardiac Disease, run by Maimonides Medical Center at 1 site in United States.
Trial summary
The investigators are presently using Exparel, a slow released local anesthestic, in patients undergoing minimally invasive cardiac surgery. The primary objective of this study is to assess the efficacy of EXPAREL when delivered into the thoracotomy and chest tube sites to provide prolonged postoperative analgesia in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Exparel infiltration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jun 2016
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-75 years inclusive and American Society of Anesthesiologists physical status 2-4.
- Undergoing minimally invasive cardiac surgery.
- Subjects must be physically and mentally able to participate in the study and complete all study assessments.
- Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the proposed components of thoracotomy and chest tube sites infiltration.
Who cannot join
- History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics
- Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a thoracotomy and chest tube sites infiltration.
- Any subject who in the opinion of the Investigator, might be harmed or be a poor candidate for participation in the study.
- Any subject, who in the opinion of the Investigator, is on chronic pain medicine, including large doses of nonsteroidal antiinflammatory drugs.
- Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Exparel for Extended Pain Control in Minimally Invasive Cardiac Surgery
The investigators are presently using Exparel, a slow released local anesthestic, in patients undergoing minimally invasive cardiac surgery. The primary objective of this study is to assess the efficacy of EXPAREL when delivered into the thoracotomy and chest tube sites to provide prolonged postoperative analgesia in patients undergoing minimally invasive cardiac surgery. Efficacy will be assessed by: the effectiveness of analgesia as measured by the subject's overall postoperative pain scores and postsurgical analgesic use.
Read the detailed description
Title of Study: Evaluation of the Efficacy of EXPAREL Delivered Into the Thoracotomy and Chest Tube Sites After Minimally Invasive Cardiac Surgery
Hypothesis: There is no difference in, the use of analgesics or the length of analgesia using Exparel infiltration when compared to regular bupivacaine.
Objectives: The investigators are presently using Exparel in patients undergoing minimally invasive cardiac surgery. The primary objective of this study is to assess the efficacy of EXPAREL when delivered into the thoracotomy and chest tube sites to provide prolonged postoperative analgesia in patients undergoing minimally invasive cardiac surgery. Efficacy will be assessed by: the effectiveness of analgesia as measured by the subject's overall postoperative pain scores and postsurgical analgesic use. The safety of EXPAREL will be assessed by the occurrence of all postsurgical adverse events and serious adverse event through Day 30.
Methodology: This is a prospective, open-label, non-randomized study evaluating the effectiveness of analgesia when using 266 mg EXPAREL delivered into the thoracotomy and chest tube sites by wide local infiltration. All patients in the study will undergo minimally invasive cardiac surgery. The total dose of EXPAREL for the thoracotomy and chest tube sites will be the same for up to 20 study subjects.: 266 mg of EXPAREL (13.3 mg/mL bupivacaine base). EXPAREL will be administered to each site. This total dose of Exparel is not to be exceeded in any subject. The thoracotomy and chest tube sites in this study will be performed immediately following surgery. Fentanyl will be the only opioid permitted intraoperatively. Post-operatively pain medications will be administered per standard of care by the anesthesia care team as needed to control the patient's pain. Patients will have access to a variety of rescue analgesics with appropriate routes of administration for breakthrough pain (e.g. opioids, acetaminophen, ketorolac, other nonsteroidal antiinflammatory drugs) in accordance with hospital standing orders for postsurgical pain management.
Subject reported pain will be recorded before surgery and at 2, 4, 8, 12, 24, 48, 72, 96, and 120 hours after the thoracotomy and chest tube site infiltration), and at a generally standard scheduled post-hospital discharge visit approximately 10±5 days after surgery. (Subjects discharged from the hospital will be contacted by telephone to record the scheduled pain assessments). Physician/healthcare professional assessed pain will be recorded when the patient is intubated and unable to communicate. Pain will also be assessed at the time of hospital discharge and at the last assessment (10±5 days) subjects also will be asked about their overall satisfaction with postsurgical analgesia Patients will also be asked to report any possible adverse events experienced since hospital discharge. If after Day 10±5 and through Day 30, the investigator is made aware of an adverse evevts that occurred during this period of time, this should also be recorded on the case report form if the investigator feels the event may be related to the study drug.
- Conditions
- Cardiac Disease
- Being tested
- Exparel infiltration
- Keywords
- minimally invasive cardiac surgery, Exparel
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exparel infiltrationDrug
Also called Bupivacaine
Exparel infiltrated into wound and chest tube sites
| Study group | Role | What they receive |
|---|---|---|
| Exparel infiltration | Experimental | Exparel infiltrated into wound and chest tube sites Receives: Drug: Exparel infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Use of Analgesics
The other primary endpoint of this study is the effectiveness of analgesia from the thoracotomy and chest tube site infiltrations as measured by the overall postsurgical analgesic use, (converted to morphine equivalents).
Measured: 5 days
Secondary outcomes (2)
Patient Satisfaction
Overall rating of subject satisfaction with postsurgical pain control
Measured: 10 days +/- 5 days
Pain Scores
Subject reported surgical pain (using an 11-point numeric rating scale ).
Measured: First 5 post-op days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Lack of available participants that meet criteria
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 Cardiac DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimonides Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Trunfio, Maimonides Medical Center
- Investigators
- Giuseppe Trunfio, MD, Principal investigator, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008370
- Sponsor's protocol ID
- 2013-07-18
- Status last verified
- Sep 2019
- First submitted
- 6 Dec 2013
- Last updated
- 4 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Exparel for Extended Pain Control in Minimally Invasive Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02008370
- Acronym / sponsor ID
- 2013-07-18
- Conditions
- Cardiac Disease
- Keywords
- minimally invasive cardiac surgery, Exparel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of available participants that meet criteria
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Maimonides Medical CenterUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Posted 4 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are presently using Exparel, a slow released local anesthestic, in patients undergoing minimally invasive cardiac surgery. The primary objective of this study is to assess the efficacy of EXPAREL when delivered into the thoracotomy and chest tube sites to provide prolonged postoperative analgesia in patients undergoing minimally invasive cardiac surgery. Efficacy will be assessed by: the effectiveness of analgesia as measured by the subject's overall postoperative pain scores and postsurgical analgesic use.
Detailed description
Title of Study: Evaluation of the Efficacy of EXPAREL Delivered Into the Thoracotomy and Chest Tube Sites After Minimally Invasive Cardiac Surgery
Hypothesis: There is no difference in, the use of analgesics or the length of analgesia using Exparel infiltration when compared to regular bupivacaine.
Objectives: The investigators are presently using Exparel in patients undergoing minimally invasive cardiac surgery. The primary objective of this study is to assess the efficacy of EXPAREL when delivered into the thoracotomy and chest tube sites to provide prolonged postoperative analgesia in patients undergoing minimally invasive cardiac surgery. Efficacy will be assessed by: the effectiveness of analgesia as measured by the subject's overall postoperative pain scores and postsurgical analgesic use. The safety of EXPAREL will be assessed by the occurrence of all postsurgical adverse events and serious adverse event through Day 30.
Methodology: This is a prospective, open-label, non-randomized study evaluating the effectiveness of analgesia when using 266 mg EXPAREL delivered into the thoracotomy and chest tube sites by wide local infiltration. All patients in the study will undergo minimally invasive cardiac surgery. The total dose of EXPAREL for the thoracotomy and chest tube sites will be the same for up to 20 study subjects.: 266 mg of EXPAREL (13.3 mg/mL bupivacaine base). EXPAREL will be administered to each site. This total dose of Exparel is not to be exceeded in any subject. The thoracotomy and chest tube sites in this study will be performed immediately following surgery. Fentanyl will be the only opioid permitted intraoperatively. Post-operatively pain medications will be administered per standard of care by the anesthesia care team as needed to control the patient's pain. Patients will have access to a variety of rescue analgesics with appropriate routes of administration for breakthrough pain (e.g. opioids, acetaminophen, ketorolac, other nonsteroidal antiinflammatory drugs) in accordance with hospital standing orders for postsurgical pain management.
Subject reported pain will be recorded before surgery and at 2, 4, 8, 12, 24, 48, 72, 96, and 120 hours after the thoracotomy and chest tube site infiltration), and at a generally standard scheduled post-hospital discharge visit approximately 10±5 days after surgery. (Subjects discharged from the hospital will be contacted by telephone to record the scheduled pain assessments). Physician/healthcare professional assessed pain will be recorded when the patient is intubated and unable to communicate. Pain will also be assessed at the time of hospital discharge and at the last assessment (10±5 days) subjects also will be asked about their overall satisfaction with postsurgical analgesia Patients will also be asked to report any possible adverse events experienced since hospital discharge. If after Day 10±5 and through Day 30, the investigator is made aware of an adverse evevts that occurred during this period of time, this should also be recorded on the case report form if the investigator feels the event may be related to the study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exparel infiltration | Experimental | Drug: Exparel infiltrationExparel infiltrated into wound and chest tube sites |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18-75 years inclusive and American Society of Anesthesiologists physical status 2-4.
- Undergoing minimally invasive cardiac surgery.
- Subjects must be physically and mentally able to participate in the study and complete all study assessments.
- Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the proposed components of thoracotomy and chest tube sites infiltration.
Key exclusion criteria (5 listed)
- History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics
- Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a thoracotomy and chest tube sites infiltration.
- Any subject who in the opinion of the Investigator, might be harmed or be a poor candidate for participation in the study.
- Any subject, who in the opinion of the Investigator, is on chronic pain medicine, including large doses of nonsteroidal antiinflammatory drugs.
- Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.
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 |
|---|---|---|
| Exparel infiltrationAlso: BupivacaineExparel infiltrated into wound and chest tube sites | Drug | Exparel infiltration |
Primary outcome
Total Use of Analgesics
Time frame: 5 days
The other primary endpoint of this study is the effectiveness of analgesia from the thoracotomy and chest tube site infiltrations as measured by the overall postsurgical analgesic use, (converted to morphine equivalents).
2 secondary outcomes
Patient Satisfaction
Time frame: 10 days +/- 5 days
Pain Scores
Time frame: First 5 post-op days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Giuseppe Trunfio, MD principal investigator
Maimonides Medical Center
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 Exparel infiltration in people with Cardiac Disease, run by Maimonides Medical Center 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 4 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: stopped early, as of the sponsor's last update on 4 Oct 2019. 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?
Yes. Results are posted in the registry (first posted 4 Oct 2019). 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?
Total Use of Analgesics (time frame: 5 days). 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 4 Oct 2019.