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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
100
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Total Opioid Consumption 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.
Time frame: up to 72 hours post-operatively
Total Intraoperative Opioid Consumption
Total intraoperative opioid consumption will be measured in morphine milligram equivalents (MME) and compared between groups.
Time frame: 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
Pain will be assessed, according to standard of care, every 4 hours using the 11-point Numerical Rating Scale (NRS), beginning at time 0 (arrival to ICU). Each patient's pain scores (higher scores indicate worse pain) within each postoperative day will be averaged, and the mean pain scores during each day and throughout the first 72 hours will be compared between the intervention and control groups. Median pain scores at 24, 48 and 72 hours post-op will be interrogated. Participants described their pain as low (range of 0-4), medium (range of 5-7) or high (range of 8-10).
Time frame: data collected immediately post-op, 24 hours, 48 hours, and 72 hours post-operatively
Maximum Pain Scores up to 72 Hours Postoperatively
Pain will be assessed, according to standard of care, every 4 hours using the 9-point Numerical Rating Scale (NRS) where higher score indicate worse pain, beginning at time 0 (arrival to ICU). The number of Participants reporting a Maximum pain score at 72 hours postoperatively will be reported. Participants described their pain as low (range of 0-4), medium (range of 5-7) or high (range of 8-9).
Time frame: up to 72 hours post-op
Pain Score at 90 Days Postoperatively
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Pain will be assessed, according to standard of care, every 4 hours using the 11-point Numerical Rating Scale (NRS) where higher score indicate worse pain. Pain at 90 days postoperative will be surveyed by phone. Pain will be assessed participants described their pain as low (range of 0-4), medium (range of 5-7) or high (range of 8-10).
Time frame: up to 90 days post-op
Daily Opioid Consumption up to 72 Hours Postoperatively
Daily opioid consumption during the initial 72 hours postoperatively will be measured in milligrams of morphine equivalents and compared between groups.
Time frame: up to 72 hours post-op
Hours of Mechanical Ventilation After ICU Admission
Duration of mechanical ventilation will be measured by hours of mechanical ventilation after admission to the ICU.
Time frame: up to 72 hours post-op
Number of Postoperative Days Until the First Bowel Movement
Return of bowel function will be measured in the number of postoperative days until the first bowel movement.
Time frame: up to 72 hours post-op
Number of Participants Reporting Postoperative Delirium Episodes Per the Confusion Assessment Method for the ICU (CAM-ICU)
Postoperative delirium episodes will be measured according to standard of care by utilizing the CAM-ICU assessment every 8-12 hours. The CAM-ICU determines either 'yes' or 'no' the participant is experiencing delirium. The number of of delirium episodes within 72 hours post-op will be determined.
Time frame: up to 72 hours post-op
Number of Hours That the Patient is in the ICU
Duration of ICU stay will be measured by the number of hours that the patient is in the ICU until an order is placed for transfer to a lower level of care.
Time frame: up to 72 hours post-op
Number of Post-operative Days Until the Patient is Discharged
Duration of hospital stay will be measured by the number of post-operative days until the patient is discharged.
Time frame: Up to 7 days
Count of Participants Using Opioids at 90 Days Postoperatively
Patient use of opioids at 90 days will be obtained by phone call.
Time frame: up to 90 days post-op