The purpose of this study is to determine if ultrasound-guided bilateral pectointercostal fascial plane blocks with bilateral rectus sheath blocks block decrease pain scores, decrease opioid consumption, improve respiratory function, and improve quality of recovery in patients recovering from elective cardiac surgery involving primary median sternotomy and mediastinal chest tubes in comparison to pectointercostal fascial plane blocks alone.
This is a single center, prospective, randomized, controlled, double-blinded study. We anticipate recruitment of 62 subjects, with 25-30 in each group. Primary Outcomes: Pain scores on a 0-10 visual analog scale (VAS) at rest and with deep breathing at 1, 3, 6, 12, 18, and 24 hours post-extubation between subjects receiving PIFB + RSB versus subjects receiving only PIFB. Total cumulative opioid consumption at 24 and 48 hours post-operatively. Secondary Outcomes: * Intraoperative total opioid consumption * Change from baseline on incentive spirometry at 1, 3, 12, and 24 hours post-extubation * Time from ICU arrival to liberation from mechanical ventilation * QoR-15 (Quality of Recovery) score23 24 hours after extubation * Hospital and ICU length of stay Preoperative Management : Subjects will be randomized on the morning of surgery to receive bilateral PIFB and bilateral RSB with local anesthetic versus bilateral PIFB with local anesthetic and bilateral RSB with saline (placebo). Intraoperative Management All subjects will receive the standard of care anesthetic regimen for their cardiac surgery. Postoperative Management Each PIFB will be performed with 15 mL of 0.25% bupivacaine with 5 mcg/ml of epinephrine, and bilateral RSB will be performed with an additional 20 mL of 0.25% bupivacaine with 5 mcg/ml of epinephrine (10mL on each side). Postoperative Evaluation: Evaluation of acute postoperative pain intensity using a 0-10 visual analog scale (VAS) will be undertaken at the following time points, both at rest and with deep breathing: • 1, 3, 6, 12, 18, and 24 hours post-extubation Incentive spirometry will be assessed at 1, 3, 12, and 24 hours post-extubation, with three measures taken at each time point in order to compare postoperative performance with baseline spirometry. Review of the medical chart will be made post-operatively to gather other data, including total intraoperative oral morphine equivalent consumption, cumulative opioid consumption at 24 and 48 hours, time from ICU arrival to tracheal extubation, hospital and ICU length of stay, and QoR-15 (Quality of Recovery) score administered 24 hours after extubation (with margin of error of 18-30 hours to avoid waking patients in the middle of the night) . Occurrences of any adverse events reported by the subject or medical team will also be collected.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
62
Rectus sheath block with local anesthetic versus sham block with saline
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Pain Scores at Rest Within the First 24 Hours After Extubation
Measured by area under the curve (AUC) for pain scores gathered at 1, 3, 6, 12, 18, and 24 hours after extubation. To calculate the Area Under the Curve (AUC) for pain scores, pain intensity is plotted against time and the trapezoidal rule is used to approximate the area under the resulting curve. This AUC value represents the overall pain experience, considering both pain intensity and duration. Scale 0-240, with higher indicating a worse outcome. Units: Numeric rating score \* hours.
Time frame: 24 hours after extubation
Pain Scores With Deep Breathing Within the First 24 Hours After Extubation
Measured by area under the curve (AUC) for pain scores gathered at 1, 3, 6, 12, 18, and 24 hours after extubation. To calculate the Area Under the Curve (AUC) for pain scores, pain intensity is plotted against time and the trapezoidal rule is used to approximate the area under the resulting curve. This AUC value represents the overall pain experience, considering both pain intensity and duration. Scale 0-240, with higher indicating a worse outcome. Units: Numeric rating score \* hours.
Time frame: 24 hours after extubation
Total Cumulative Opioid Consumption
Total cumulative opioid consumption at 24 hours
Time frame: 24 hours post-operatively
Total Cumulative Opioid Consumption
Total cumulative opioid consumption at 48 hours
Time frame: 48 hours post-operatively
Time From ICU Arrival to Liberation From Mechanical Ventilation
Time from ICU arrival as measured by "anesthesia stop" to liberation from mechanical ventilation (extubation).
Time frame: ICU arrival until extubation
Vital Capacity Change From Baseline on Incentive Spirometry
Vital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL).
Time frame: 1 hour post-extubation
Vital Capacity Change From Baseline on Incentive Spirometry
Vital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL).
Time frame: 3 hours post-extubation
Vital Capacity Change From Baseline on Incentive Spirometry
Vital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL).
Time frame: 12 hours post-extubation
Vital Capacity Change From Baseline on Incentive Spirometry
Vital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL).
Time frame: 24 hours post-extubation
QoR-15 (Quality of Recovery) Score
QoR-15 (Quality of Recovery) score is a 15 question survey asking patients about various aspects of their quality of recovery, including pain control, nausea, anxiety, depression, ability to eat, etc. The scale is 0-150, with higher scores indicating a better outcome.
Time frame: 24 hours after extubation
ICU Length of Stay
ICU Length of Stay in hours, as measured by anesthesia stop until transfer out of the ICU.
Time frame: Time from anesthesia stop to transfer out of ICU, typically 24 hours
Hospital Length of Stay
Hospital Length of Stay in hours, as measured by anesthesia stop until discharge from the hospital.
Time frame: Time from anesthesia stop to hospital discharge, typically one week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.