Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery

Phase 3

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Interventional Bupivacaine	Bupivacaine Group	20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1
Interventional Placebo	Placebo	20 cc of saline on each side of the sternum at two time points after surgery and POD1

Primary Outcome Measures

Name	Time	Method
Opioid Consumption	48 hours	Total opioid consumption in the first 48 hours post-operatively, measured as milligram morphine equivalents (MME).

Secondary Outcome Measures

Name	Time	Method
Pain Scores	At 6-8 hourly intervals every day until discharge or 4 days	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.
ICU Length of Stay	Time of ICU admission until time of discharge to hospital floor; through the hospital stay, an average of 5 days	Total duration of stay in ICU for the index admission
Hospital Length of Stay	Measured in days admitted in the hospital, an average of 5 days	Their stay in the hospital for the index admission
Number of Participants With Complications	7 days post-op on an average	This includes infection, hematoma, local anesthetic systemic toxicity directly related to the block or the drug used in the block