Pecto-Intercostal Fascial Plane Block Study
Condition: Cardiac Surgery; Opioid Use, Unspecified
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      Thousands of heart surgeries are performed every day in the United States. Unattenuated
      perioperative pain has been shown to contribute to increased morbidity, mortality, length of
      stay, and healthcare costs. Practice guidelines from the American Society of Regional
      Anesthesiologists recommend pre-incision techniques to reduce perioperative pain, however in
      cardiac surgery, there are no commonly used techniques to follow this recommendation. The
      PIFB is a newly described fascial plane block and existing literature supports the safety and
      efficacy of the PIFB in cardiac surgery patients. However, there are no randomized controlled
      trials evaluating this technique with a long-acting depot local anesthetic.

      The purpose of this study is to determine whether bilateral pecto-intercostal fascial plane
      blocks with liposomal bupivacaine decrease pain and opioid requirements in patients
      undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with
      saline). The primary hypothesis is that patients receiving effective regional anesthesia with
      liposomal bupivacaine via PIFB will demonstrate a clinically significant (25%) reduction in
      total daily opioid consumption through 72 hours postoperatively compared to patients
      receiving standard of care without effective regional anesthesia (saline only via PIFB).

      This study is a prospective, single-center, randomized, double-blind, controlled trial to
      evaluate whether bilateral pecto-intercostal fascial plane blocks with liposomal and standard
      bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via
      median sternotomy compared to controls (sham blocks with saline).

      The participants will be randomized to receive bilateral PIFB with a mixture of standard and
      liposomal bupivacaine or bilateral PIFB with saline only. Recovery characteristics, including
      opioid consumption, pain scores, duration of mechanical ventilation, ICU length of stay,
      hospital length of stay, side effects, and chronic opioid use will be evaluated.
    

Intervention name(s): Bupivacaine Injection; Liposomal bupivacaine; Saline
Intervention type(s): Drug; Drug; Other
Intervention description(s): 10mL of 0.25% bupivacaine; 15mL of 133mg liposomal bupivacaine; 25mL saline control
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective, single-center, randomized, double-blind, controlled trial
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care