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This randomized blinded trial aims to evaluate the effect of parasternal intercostal and rectus sheath blocks ("anterior blocks for cardiac surgery" or ABC blocks) on postoperative recovery in patients undergoing median sternotomy for cardiac surgery. Subjects will be randomized to receive either local anesthetic (liposomal bupivacaine plus bupivacaine 0.25%) or saline sham block.
Subjects will be randomized on the morning of surgery to receive either "anterior blocks for cardiac surgery" or "ABC blocks" using 60 mL of local anesthetic mixture (20 mL of liposomal bupivacaine plus 40 mL of 0.25% bupivacaine) or a sham saline ABC block (60 mL). All subjects will receive standard of care anesthetic regimen for their cardiac surgery at the discretion of his/her attending anesthesiologist. 40 mL of the solution will be administered in the parasternal intercostal space, and 20 mL will be placed in the rectus sheath in the epigastric region.
For the parasternal blocks, a linear high frequency ultrasound probe will be placed parasagitally at the T2-3 level approximately 3cm lateral to the mid-sternum, and all relevant structures will be identified, including the pectoralis major muscle, internal intercostal muscle, ribs, pleura, and any vasculature, including the internal mammary artery and vein. Color Doppler will be used confirm the location of vasculature.
After skin local anesthetic infiltration, a 10 cm 21G insulated block needle (Sonoplex, Pajunk Medical Systems, Norcross, GA) will be inserted from the inferior aspect of the ultrasound probe in a caudal to cranial direction and aligned with the ultrasound scanning plane (in-plane approach). In this way, both the needle shaft and tip can be visualized as the needle approaches the plane between the pectus major and intercostal muscles. The needle will be redirected as needed. Once satisfactory position of the needle time is confirmed and after frequent negative aspiration, 10 mL of study solution will be slowly injected. This injection will be repeated at the T4-5 interspace. Spread of local anesthetic will be documented in the appropriate plane in real time. This procedure will be performed bilaterally.
For the rectus sheath blocks, a linear high frequency ultrasound probe will be placed in a transverse position in the midline, just inferior to the xiphoid process. The probe will be moved laterally to visualize the lateral edge of the rectus abdominis muscle. A 10 cm 21G insulated block needle will be inserted from the lateral aspect of the ultrasound probe in a lateral to medial direction until visualized deep to the muscle immediately adjacent to the posterior rectus sheath. After negative aspiration, 10 mL of study solution will be slowly injected into this plane. This procedure will then be repeated on the contralateral side
All nerve blocks will be performed by a trainee supervised by an anesthesiologist experienced in regional anesthesia. The anesthesiology team and in the OR will be blinded to group allocation.
Subjects will receive a general anesthetic consistent with standard of care for cardiac surgeries at the discretion of his/her attending anesthesiologist. At the conclusion of the case, subjects will be extubated and/or transported to the ICU intubated. The decision to extubate the subject in the OR will be made at the discretion of the attending anesthesiologist.
Evaluation of acute postoperative pain intensity using a 0-10 visual analog scale (VAS) and opioid consumption will be undertaken at the following time points:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABC block with bupivacaine and liposomal bupivacaine | Active Comparator | The study solution used in the active arm will comprise 20 mL of liposomal bupivacaine (266 mg) admixed with 40 mL of 0.25% bupivacaine HCl. The solution will be administered as bilateral parasternal blocks (40 mL) and bilateral epigastric rectus sheath blocks (20 mL). |
|
| ABC block with saline | Sham Comparator | The study solution used in the active arm will comprise 60 mL of 0.9% saline. The solution will be administered as bilateral parasternal blocks (40 mL) and bilateral epigastric rectus sheath blocks (20 mL). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABC block with bupivacaine/liposomal bupivacaine | Drug | Patients will be randomized to receive an ABC block using bupivacaine/liposomal bupivacaine solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative opioid consumption from extubation to 24 hours post-extubation | Morphine equivalents administered between extubation and 24 hours post-extubation | Extubation to 24 hr post-extubation |
| Measure | Description | Time Frame |
|---|---|---|
| Worst pain at rest at 2 hours post-extubation | Pain intensity as measured on Numeric Pain Rating Scale (NRS-11) at 2 hours post-extubation. The NRS-11 ranges from '0' (no pain) to '10' (worst pain imaginable). | 2 hours post-extubation |
| Worst pain at rest at 6 hours post-extubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Manning, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital | Durham | North Carolina | 27705 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| ABC block with saline | Drug | Patients will be randomized to receive an ABC block using normal saline |
|
Pain intensity as measured on Numeric Pain Rating Scale (NRS-11) at 6 hours post-extubation. The NRS-11 ranges from '0' (no pain) to '10' (worst pain imaginable). |
| 6 hours post-extubation |
| Worst pain at rest at 24 hours post-extubation | Pain intensity as measured on Numeric Pain Rating Scale (NRS-11) at 24 hours post-extubation. The NRS-11 ranges from '0' (no pain) to '10' (worst pain imaginable). | 24 hours post-extubation |
| Worst pain at rest at 48 hours post-extubation | Pain intensity as measured on Numeric Pain Rating Scale (NRS-11) at 48 hours post-extubation. The NRS-11 ranges from '0' (no pain) to '10' (worst pain imaginable). | 48 hours post-extubation |
| Cumulative opioid consumption from extubation to 48 hours post-extubation | Morphine equivalents administered between extubation and 48 hours post-extubation | Extubation to 48 hr post-extubation |
| Time from end of case to tracheal extubation | Time from end of surgical case (as defined by nursing record) until tracheal extubation | End of operative case until patient extubated, up to 24 hours |
| ICU length of stay | Duration of time spent in cardiothoracic ICU from admission to discharge | Postoperative from admission to ICU to discharge to floor, approximately 3 days |
| Time to first session of physical therapy (PT) | Time from ICU admission until first session of physical therapy | 0-48 hours after surgical procedure |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |