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NCT05676814
Pecto-intercostal Fascial Block (PIFB) for Postop Analgesia Following Sternotomy in Cardiac Surgery Patients
Conditions: Analgesia, Sternotomy
Sex: All
Ages: 18 Years – 90 Years
Phase: PHASE4
Enrollment: 20
Sponsor: Wake Forest University Health Sciences
Location: United States
Summary
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.
Eligibility Criteria
Inclusion Criteria:Adults between undergoing cardiac surgery involving sternotomyExclusion Criteria:Patients with any contraindications to regional anesthesia, such as history of allergy to amide local anesthetics or any of the perineural adjuvantsexisting neurologic deficit in the chest wall;remaining intubated at the six hour point after block placementweight under 50kgundergoing emergency surgical procedures or urgent return to the operating roomactive endocarditis or mediastinitismoderate to severe right ventricular function before or after cardiopulmonary bypassreliance on mechanical circulatory support devices, such as intra-aortic balloon pump or Impellareliance on extracorporeal membrane oxygenationlocalized or systemic infectionchronic 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
Source: ClinicalTrials.gov (NCT05676814). StuddyBuddy aggregates publicly available trial information.