Pecto-Intercostal Fascial Plane Block for Enhanced Recovery After Cardiac Surgery

2021-0111

This study is being done to see if bilateral pecto-intercostal fascial plane blocks (PIFB) with a mixture of liposomal and standard bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with saline). 100 participants will be recruited and can expect to be on study for 100 days.

2022-03-28

2023-09-03

2023-11-30

Completed

Early phase I

100

Inclusion Criteria: * Participant provides consent to participate in study * Ideal body weight (IBW) is \>50kg * Participant is planned to undergo coronary artery bypass graft or single valve repair/replacement surgery via median sternotomy * Participant is undergoing an elective procedure Exclusion Criteria: * Participant is unable or unwilling to give consent * Non-English speaking * Known or believed to be pregnant or is currently breastfeeding * Participant is a prisoner * Clinically unstable per discretion of the Investigator * Participant requires urgent/emergent surgery * History of previous sternotomy * Preoperative coagulopathy (INR \>1.4, platelets \<100,000) or ongoing anticoagulation or anti-platelet therapy (except aspirin 81mg) * Allergy or sensitivity to amide-type local anesthetics, dexmedetomidine or ketamine * Participant has decompensated heart failure * Severe left ventricle dysfunction (defined quantitatively as an ejection fraction of less than or equal to 35%) or right ventricle dysfunction (defined qualitatively as "severe") * Diagnosis of cirrhosis or end-stage liver disease * Requires the use of mechanical circulatory support pre-operatively * Participant uses chronic opioids (meaning at the time of the preoperative screening evaluation by the study team, the patient is prescribed and taking any opioid pain medication)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective, single-center, randomized, double-blind, controlled trial', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Each study participant and OR anesthesia team, cardiac surgery team, cardiothoracic ICU team, and nursing staff caring for the participant will be blinded to the study drug the patient received. However, the anesthesia provider performing the block (separate from the provider caring for the patient in the operating room) will not be blinded to the study drug injected and will have access to all monitors deemed appropriate by the primary team caring for the participant.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}

2024-01-23