Status:
COMPLETED
Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery
Lead Sponsor:
Beth Israel Deaconess Medical Center
Conditions:
Coronary Artery Disease
Sternal Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 cardia...
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 cardia...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients 18 years of age or older
- Undergoing cardiac surgery with sternotomy, limited to CABG, CABG+valve surgeries and isolated valve surgeries.
- Exclusion Criteria
- 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
- 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
Exclusion
Key Trial Info
Start Date :
June 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2019
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03482973
Start Date
June 21 2018
End Date
November 27 2019
Last Update
August 3 2020
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215