The purpose of this study is to determine whether administration of a pecto-intercostal fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative analgesia after cardiac surgery as compared to patients who receive a sham block of normal saline.
The purpose of this study is to determine whether administration of a pecto-intercostal fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative analgesia after cardiac surgery as compared to patients who receive a sham block of normal saline. Specific Aim 1: To determine whether or not a PIFB with bupivacaine can reduce postoperative pain after cardiac surgery. This will be assessed through: (Aim 1A) opioid consumption in the first 48 hours postoperatively (Aim 1B) patient self-reported pain scores during their hospital stay Specific Aim 2: To estimate the effect size in order to obtain information that can be used to power future research on the use of regional modalities of analgesia for cardiac surgeries.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).
20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Opioid Consumption
Total opioid consumption in the first 48 hours post-operatively, measured as milligram morphine equivalents (MME).
Time frame: 48 hours
Pain Scores
Patient reported pain scores on a scale from 0-10 until discharge for the index admission. Where the minimum score is 0 and, the maximum score is 10. A score of 0 means no pain and the higher the score, the greater the pain intensity, with a score of 10 means worse imaginable pain. Pain scores recorded at 6-8 hourly intervals every day until discharge or 4 days, computed as an average pain score.
Time frame: At 6-8 hourly intervals every day until discharge or 4 days
ICU Length of Stay
Total duration of stay in ICU for the index admission
Time frame: Time of ICU admission until time of discharge to hospital floor; through the hospital stay, an average of 5 days
Hospital Length of Stay
Their stay in the hospital for the index admission
Time frame: Measured in days admitted in the hospital, an average of 5 days
Number of Participants With Complications
This includes infection, hematoma, local anesthetic systemic toxicity directly related to the block or the drug used in the block
Time frame: 7 days post-op on an average
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