Coronary Artery DiseasePhase 3NCT03482973
Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery
A Phase 3 study testing Bupivacaine Group in people with Coronary Artery Disease and Sternal Pain, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether administration of a pecto-intercostal fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative analgesia after cardiac surgery as compared to patients who receive a sham block of normal saline. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Sternal Pain
- What is being tested?
- Bupivacaine Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2018to 27 Nov 2019
- Phase
- Phase 3
- 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
Who may be able to join
- Patients 18 years of age or older
- Undergoing cardiac surgery with sternotomy, limited to CABG, CABG+valve surgeries and isolated valve surgeries.
Who cannot join
- Current participation in another interventional study
- Preoperative LVEF < 30%
- Use of mechanical circulatory support
- Emergent procedures
- Aortic surgeries, transplants ventricular assist device insertions, bentall, or grafts
- Minimally invasive cardiac procedures or those with thoracotomy approach
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- Patients receiving other modalities of regional anesthesia like intrathecal morphine
- Chronic opioid use for chronic pain conditions with tolerance (total daily dose of an opioid at or more than 30 mg morphine equivalent for more than one month within the past year)
- Current use of TCA, gabapentin, or pregabalin
- Hypersensitivity to bupivacaine
- Women who are pregnant or breastfeeding
- Non English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
The purpose of this study is to determine whether administration of a pecto-intercostal fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative analgesia after cardiac surgery as compared to patients who receive a sham block of normal saline.
Read the detailed description
The purpose of this study is to determine whether administration of a pecto-intercostal fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative analgesia after cardiac surgery as compared to patients who receive a sham block of normal saline.
Specific Aim 1: To determine whether or not a PIFB with bupivacaine can reduce postoperative pain after cardiac surgery. This will be assessed through:
(Aim 1A) opioid consumption in the first 48 hours postoperatively (Aim 1B) patient self-reported pain scores during their hospital stay
Specific Aim 2: To estimate the effect size in order to obtain information that can be used to power future research on the use of regional modalities of analgesia for cardiac surgeries.
- Conditions
- Coronary Artery Disease, Sternal Pain
- Being tested
- Bupivacaine Group, Placebo
- Keywords
- Cardiopulmonary Bypass, Cardiac Surgery, Sternotomy
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine GroupDrug
20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).
PlaceboOther
20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).
| Study group | Role | What they receive |
|---|---|---|
| Interventional Bupivacaine | Experimental | 20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1 Receives: Drug: Bupivacaine Group |
| Interventional Placebo | Placebo comparator | 20 cc of saline on each side of the sternum at two time points after surgery and POD1 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption
Total opioid consumption in the first 48 hours post-operatively, measured as milligram morphine equivalents (MME).
Measured: 48 hours
Secondary outcomes (4)
Pain Scores
Patient reported pain scores on a scale from 0-10 until discharge for the index admission. Where the minimum score is 0 and, the maximum score is 10. A score of 0 means no pain and the higher the score, the greater the pain intensity, with a score of 10 means worse imaginable pain. Pain scores recorded at 6-8 hourly intervals every day until discharge or 4 days, computed as an average pain score.
Measured: At 6-8 hourly intervals every day until discharge or 4 days
ICU Length of Stay
Total duration of stay in ICU for the index admission
Measured: Time of ICU admission until time of discharge to hospital floor; through the hospital stay, an average of 5 days
Hospital Length of Stay
Their stay in the hospital for the index admission
Measured: Measured in days admitted in the hospital, an average of 5 days
Number of Participants With Complications
This includes infection, hematoma, local anesthetic systemic toxicity directly related to the block or the drug used in the block
Measured: 7 days post-op on an average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start21 Jun 2018
- Primary completion25 Nov 2019
- Study completion27 Nov 2019
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 Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Balachundhar Subramaniam, Beth Israel Deaconess Medical Center
- Investigators
- Balachundhar Subramaniam, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482973
- Sponsor's protocol ID
- 2018P000044
- Status last verified
- Jul 2020
- First submitted
- 5 Mar 2018
- Last updated
- 3 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03482973
- Acronym / sponsor ID
- 2018P000044
- Conditions
- Coronary Artery Disease, Sternal Pain
- Keywords
- Cardiopulmonary Bypass, Cardiac Surgery, Sternotomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 27 Nov 2019 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Posted 3 Aug 2020
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 determine whether administration of a pecto-intercostal fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative analgesia after cardiac surgery as compared to patients who receive a sham block of normal saline.
Detailed description
The purpose of this study is to determine whether administration of a pecto-intercostal fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative analgesia after cardiac surgery as compared to patients who receive a sham block of normal saline.
Specific Aim 1: To determine whether or not a PIFB with bupivacaine can reduce postoperative pain after cardiac surgery. This will be assessed through:
(Aim 1A) opioid consumption in the first 48 hours postoperatively (Aim 1B) patient self-reported pain scores during their hospital stay
Specific Aim 2: To estimate the effect size in order to obtain information that can be used to power future research on the use of regional modalities of analgesia for cardiac surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Bupivacaine | Experimental | Drug: Bupivacaine Group20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1 |
| Interventional Placebo | Placebo comparator | Other: Placebo20 cc of saline on each side of the sternum at two time points after surgery and POD1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 years of age or older
- Undergoing cardiac surgery with sternotomy, limited to CABG, CABG+valve surgeries and isolated valve surgeries.
Key exclusion criteria (12 listed)
- Current participation in another interventional study
- Preoperative LVEF < 30%
- Use of mechanical circulatory support
- Emergent procedures
- Aortic surgeries, transplants ventricular assist device insertions, bentall, or grafts
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 |
|---|---|---|
| Bupivacaine Group20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1). | Drug | Interventional Bupivacaine |
| Placebo20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1). | Other | Interventional Placebo |
Primary outcome
Opioid Consumption
Time frame: 48 hours
Total opioid consumption in the first 48 hours post-operatively, measured as milligram morphine equivalents (MME).
4 secondary outcomes
Pain Scores
Time frame: At 6-8 hourly intervals every day until discharge or 4 days
ICU Length of Stay
Time frame: Time of ICU admission until time of discharge to hospital floor; through the hospital stay, an average of 5 days
Hospital Length of Stay
Time frame: Measured in days admitted in the hospital, an average of 5 days
Number of Participants With Complications
Time frame: 7 days post-op on an average
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- 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.
Balachundhar Subramaniam principal investigator
Beth Israel Deaconess 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 3 study testing Bupivacaine Group in people with Coronary Artery Disease and Sternal Pain, run by Beth Israel Deaconess 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 2 inclusion and 12 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 3 Aug 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 3 Aug 2020). 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?
Opioid Consumption (time frame: 48 hours). 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 3 Aug 2020.