Pecto-intercostal Fascial Block (PIFB) for Postop Analgesia Following Sternotomy in Cardiac Surgery Patients

Completed · Phase 4

Conditions studied: Analgesia, Sternotomy

In brief

The purpose of this randomized, triple-blinded, prospective, feasibility study is to compare postoperative analgesia provided by Pecto-intercostal Fascial Block (PIFB) when performed with local anesthetic solution with or without perineural adjuvants in patients following cardiac surgery involving sternotomy. The study team hypothesizes that the patients receiving PIFB with bupivacaine with epinephrine, clonidine, and dexamethasone will have lower dynamic pain over the first 36 hours compared to those receiving PIFB with just bupivacaine and epinephrine.

Key facts

Study ID

NCT05676814

Run by

Wake Forest University Health Sciences

People needed

31

Starts

2023-03-24

Expected to finish

2023-06-24

Last updated by the study team

2024-06-11

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults between undergoing cardiac surgery involving sternotomy

You may not qualify if…

• Patients with any contraindications to regional anesthesia, such as history of allergy to amide local anesthetics or any of the perineural adjuvants
• existing neurologic deficit in the chest wall;
• remaining intubated at the six hour point after block placement
• weight under 50kg
• undergoing emergency surgical procedures or urgent return to the operating room
• active endocarditis or mediastinitis
• moderate to severe right ventricular function before or after cardiopulmonary bypass
• reliance on mechanical circulatory support devices, such as intra-aortic balloon pump or Impella
• reliance on extracorporeal membrane oxygenation
• localized or systemic infection
• chronic use of high dose opioid analgesics (defined as daily use greater than 30 oral morphine milligram equivalents (OMME) for over one month prior to surgery)
• those who are pregnant

Where it is running

• Wake Forest Health Sciences — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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