Pecto-Intercostal Fascial Plane Block for Enhanced Recovery After Cardiac Surgery
Overview
- Phase
- Phase 4
- Intervention
- Bupivacaine Injection
- Conditions
- Cardiac Surgery
- Sponsor
- University of Wisconsin, Madison
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Total Opioid Consumption 72 Hours Post-operatively
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
PIFB intervention
bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL)
Intervention: Bupivacaine Injection
PIFB intervention
bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL)
Intervention: Liposomal bupivacaine
Saline Control
bilateral PIFB with 25 mL saline only
Intervention: Saline
Outcomes
Primary Outcomes
Total Opioid Consumption 72 Hours Post-operatively
Time Frame: up to 72 hours post-operatively
Total opioid consumption during the initial 72 hours post-operatively will be measured in morphine milligram equivalents (MME) and compared between groups.
Secondary Outcomes
- Total Intraoperative Opioid Consumption(intraoperative period ranging from anesthesia start time to anesthesia end time)
- Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op(data collected immediately post-op, 24 hours, 48 hours, and 72 hours post-operatively)
- Maximum Pain Scores up to 72 Hours Postoperatively(up to 72 hours post-op)
- Pain Score at 90 Days Postoperatively(up to 90 days post-op)
- Daily Opioid Consumption up to 72 Hours Postoperatively(up to 72 hours post-op)
- Hours of Mechanical Ventilation After ICU Admission(up to 72 hours post-op)
- Number of Postoperative Days Until the First Bowel Movement(up to 72 hours post-op)
- Number of Participants Reporting Postoperative Delirium Episodes Per the Confusion Assessment Method for the ICU (CAM-ICU)(up to 72 hours post-op)
- Number of Hours That the Patient is in the ICU(up to 72 hours post-op)
- Number of Post-operative Days Until the Patient is Discharged(Up to 7 days)
- Count of Participants Using Opioids at 90 Days Postoperatively(up to 90 days post-op)