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This is a randomized, double-blind, controlled clinical trial is to evaluate the duration of efficacy of parasternal blocks with the use of local anesthetic adjuncts for analgesia after coronary artery bypass grafting surgery.
This study will randomize patients to either standard pain control protocols or parasternal blocks after coronary artery bypass grafting-only surgery. This study will specifically examine the effectiveness and duration of analgesia of parasternal blocks with local anesthetic adjuncts, Dexamethasone 10mg and Dexmedetomidine 50mcg, added to the local anesthetic mixture
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Patients will receive bilateral parasternal blocks at the end of cardiac surgery. |
|
| Control group | Placebo Comparator | Patients will receive all standard care as per the hospital protocols. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parasternal blocks | Drug | Parasternal block with Bupivacaine 0.25% + Epinephrine 1:200,000 x 60cc + Dexamethasone 5mg and Dexmedetomidine 50mcg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain with inspirometry at 24 hours after surgery | Numerical Rating Scale (NRS) pain score from the sternotomy site during inspirometry. The VAS score is a scale from 0 to 10 where 0 is equivalent to "no pain" and 10 is equal to "the worst imaginable pain" | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption | Amount of opioid administered (mg of Dilaudid) | 12, 24 and 48 hours after surgery |
| Amount of rescue analgesia administered | Amount of ketorolac or ketamine administered |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of postoperative vomiting | Vomiting after surgery | first 48 hours after surgery |
| Incidence of bradycardia | Heart rate less than 60 beats per minute |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jewish General Hospital | Montreal | Quebec | H3T1E2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39689005 | Derived | Cameron MJ, Long J, Yang SS, Kardash K. How Many Patients Are Needed to Detect a Difference in Pain With Parasternal Blocks? Anesth Analg. 2025 Jul 1;141(1):210-211. doi: 10.1213/ANE.0000000000007355. Epub 2024 Dec 17. No abstract available. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of care | Drug | All standard management of postoperative pain, as per local protocols |
|
| Total in the first 48 hours after surgery |
| Pain score at rest | Numerical Rating Scale (NRS) pain score from the sternotomy site during inspirometry. The VAS score is a scale from 0 to 10 where 0 is equivalent to "no pain" and 10 is equal to "the worst imaginable pain" | 12, 24 and 48 hours after surgery |
| Pain score with inspirometry | Numerical Rating Scale (NRS) pain score from the sternotomy site during inspirometry. The VAS score is a scale from 0 to 10 where 0 is equivalent to "no pain" and 10 is equal to "the worst imaginable pain" | 12 and 48 hours after surgery |
| Intensive Care Unit (ICU) Length of Stay | Time spent in the intensive care unit after surgery (days) | From surgery until discharge from the ICU, assessed from the date of surgery up until 6 months after the completion of the study |
| Hospital Length of Stay | Time spent in the hospital after surgery (days) | From the date of surgery up until discharge from hospital, followed from the date of surgery up until 6 months after the completion of the study |
| Inspirometry | Volume inspired on inspirometry | 24 hours after surgery |
| Patient satisfaction with pain control | 0 "extremely unsatisfied" to 10 "extremely satisfied" | at 48 hours after surgery |
| Mobilization | Time from ICU arrival to the first mobilization to a chair | From ICU arrival until first mobilization (approximately first 48 hours postoperatively) |
| Ambulation | Time from ICU arrival to the first mobilization to a chair | From ICU arrival until first ambulation (approximately first 72 hours postoperatively) |
| first 48 hours after surgery |
| Incidence of hyperglycemia | Glucose greater than 10 millimoles/liter | first 48 hours after surgery |
| Incidence of a pneumothorax | Pneumothorax identified on chest x-ray | first 48 hours after surgery |
| Local anesthetic toxicity | Local anesthetic toxicity, as diagnosed clinically | first 48 hours after surgery |
| Postoperative Delirium | Delirium as defined by the "Confusion assessment method for the ICU" (CAM-ICU) | first 48 hours after surgery |
| Narcotic prescription on discharge | Having a narcotic prescription on discharge | Upon discharge from hospital after surgery (approximately 1 week after surgery) |
| Sternal pain at 3 months | Persistent pain at the sternum | Three months after the day of surgery |
| Local anesthetic spread | Number of levels of spread of local anesthetic, as identified by ultrasound | Immediately as intervention is performed |