Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery

Completed · Phase 3 · Has a placebo group

Conditions studied: Coronary Artery Disease, Sternal Pain

In brief

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.

Key facts

Study ID

NCT03482973

Run by

Beth Israel Deaconess Medical Center

People needed

80

Starts

2018-06-21

Expected to finish

2019-11-27

Last updated by the study team

2020-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients 18 years of age or older
• Undergoing cardiac surgery with sternotomy, limited to CABG, CABG+valve surgeries and isolated valve surgeries.

You may not qualify if…

• 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

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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