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This is a randomized study. The purpose of this study is to evaluate the effect of post-surgical pain control of two types of peripheral nerve blocks, specifically erector spinal plane (ESP) block and pecto-intercostal fascial (PIF) plane block.
90 subjects, from 18-85 years of age, undergoing cardiac surgery with median sternal incision will be enrolled at Mount Sinai Morningside Hospital Center. Study participation will last from the time of pre-operative evaluation to 72 hours after surgery. Subjects will be randomly assigned to receive 1 of the 3 different regimens at the beginning of surgery. Opioid consumption and pain scores after surgery will be evaluated. Though unlikely, risks include systemic absorption of local anesthetic, which can result in both central nervous system and cardiac toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESP group | Experimental | Patient will receive ESP block with ultrasound guidance the transverse process of the vertebra at T7 is visualized and 20 mL of 0.25% bupivacaine will be injected between the transverse process and the erector spinae muscle on each side using a 21-gauge block needle. |
|
| PIF group | Experimental | Patient will receive PIF block after intubation with ultrasound placed 1-2 cm lateral to the sternal border and the pectoralis major and external intercostal muscles are visualized at the level of ribs 3-4 where 10 mL of 0.25% bupivacaine will be injected on each side using a 21-gauge block needle. |
|
| No Block group | No Intervention | Patient will not receive block. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESP block | Procedure | peripheral nerve block |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption during first 24 hours post-op | The amount of opioid consumption (in mg IV morphine equivalents) during the first 24 hours post-op in patients undergoing cardiac surgeries with median sternotomy. | Post-operative 24 hours |
| Opioid Consumption during first 48 hours post-op | The amount of opioid consumption (in mg IV morphine equivalents) during the first 48 hours post-op in patients undergoing cardiac surgeries with median sternotomy. | Post-operative 48 hours |
| Opioid Consumption during first 72 hours post-op | The amount of opioid consumption (in mg IV morphine equivalents) during the first 72 hours post-op in patients undergoing cardiac surgeries with median sternotomy. | Post-operative 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Score (VAS) Pain Score post-op 24 hours | VAS Pain Score from 0-10, with higher score indicating more pain. The average VAS pain scores during the first 24 hours post-op in patients undergoing cardiac surgeries with median sternotomy. | Post-operative 24 hours |
| Visual Analogue Score (VAS) Pain Score post-op 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali Shariat, M.D. | Mount Sinai West and Morningside Hospitals | Principal Investigator |
| Himani Bhatt, D.O. | Mount Sinai West and Morningside Hospitals | Study Director |
| Shenghao Fang, M.D. | Mount Sinai West and Morningside Hospitals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Morningside Hospital | New York | New York | 10025 | United States |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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Patients will be assigned randomly using a computer-generated table of numbers to one of the three groups: 1) ESP group, 2) PIF group, or 3) no block group.
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The anesthesiologist assessing the patient will be blinded
| PIF block | Procedure | peripheral nerve block |
|
|
| Ultrasound | Procedure | Ultrasound guidance |
|
| Bupivacain | Drug | 10-20 mL of 0.25% bupivacaine |
|
VAS Pain Score from 0-10, with higher score indicating more pain. The average VAS pain scores during the first 48 hours post-op in patients undergoing cardiac surgeries with median sternotomy. |
| Post-operative 48 hours |
| Visual Analogue Score (VAS) Pain Score post-op 72 hours | VAS Pain Score from 0-10, with higher score indicating more pain. The average VAS pain scores during the first 72 hours post-op in patients undergoing cardiac surgeries with median sternotomy. | Post-operative 72 hours |
| D055585 |
| Physical Phenomena |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |