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The aim of this randomized controlled trial is to examine the effect of ultrasound guided bilateral Parasternal Nerve Block combined with rectus sheath block on preoperative analgesia, opioid consumption and respiratory function in patients undergoing cardiac surgery via sternotomy. Half of participants will receive General Anesthesia combined with bilateral parasternal block and rectus sheath block while the other half receive General Anesthesia combined with bilateral parasternal block and infiltration of drainage exits sites with local anesthetic (without performing rectus sheath block)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RECTUS group | Experimental | Patients will receive General Anesthesia combined with bilateral parasternal block and rectus sheath block |
|
| CONTROL group | Active Comparator | Patients will receive General Anesthesia combined with bilateral parasternal block and infiltration of drainage exits sites with local anesthetic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PARASTERNAL BLOCK | Procedure | After induction of general anesthesia, an ultrasound-guided Parasternal Block will be performed with 20 mL of ropivacaine 0.5 % per side. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Static Pain Score | A numerical rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain) will be used to evaluate pain at rest during 24 hours after surgery | 24 hours |
| Dynamic Pain Score | A numerical rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain) during movement will be used to evaluate pain at rest during 24 hours after surgery | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Fentanyl Consumption | Total intravenous fentanyl administration (expressed in milligrams) during surgery | 4 hours |
| Morphine Consumption | Total of intravenous morphine (expressed in milligrams) administered during the first 24 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Pascarella, MD | University Hospital Campus Biomedico of Rome | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Campus Bio-medico University Hospital Foundation | Rome | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33990437 | Result | Bloc S, Perot BP, Gibert H, Law Koune JD, Burg Y, Leclerc D, Vuitton AS, De La Jonquiere C, Luka M, Waldmann T, Vistarini N, Aubert S, Menager MM, Merzoug M, Naudin C, Squara P. Efficacy of parasternal block to decrease intraoperative opioid use in coronary artery bypass surgery via sternotomy: a randomized controlled trial. Reg Anesth Pain Med. 2021 Aug;46(8):671-678. doi: 10.1136/rapm-2020-102207. Epub 2021 May 14. | |
| 17678782 |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D000377 | Agnosia |
| D059787 | Acute Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| LOCAL INFILTRATION OF DRAINAGE EXIT SITES | Procedure | At the end of surgery, a local infiltration of drainage exit sites will be performed with 10 mL of ropivacaine 0.25% per side |
|
| RECTUS SHEATH BLOCK | Procedure | At the end of surgery, a rectus sheath block will be performed with 10 mL of ropivacaine 0.25% per side. |
|
| 24 hours |
| Time of Extubation | Interval between the end of surgery and patient's extubation | 48 hours |
| Respiratory performance at incentive spirometry | Respiratory performance is assessed preoperatively and postoperatively (at extubation) by the number of balls raised during inspiration with the TRI-FLOW spirometer | 48 hours |
| Intensive Care Unit (ICU) Discharge Time | Interval between patient arrival in ICU and discharge from ICU | 120 hours |
| Hospitalization Length of Stay | Total Hospital length of Stay (expressed in days) | 30 days |
| Incidence of adverse events | Any complications or side effects of the blocks, such as local infection, intravascular injection of local anesthetics and immediate systemic toxicity. Moreover, incidence of nausea, vomiting and postoperative respiratory complications will be recorded. | 24 hours |
| Result |
| Barr AM, Tutungi E, Almeida AA. Parasternal intercostal block with ropivacaine for pain management after cardiac surgery: a double-blind, randomized, controlled trial. J Cardiothorac Vasc Anesth. 2007 Aug;21(4):547-53. doi: 10.1053/j.jvca.2006.09.003. Epub 2006 Dec 22. |
| 27746544 | Result | Elbahrawy K, El-Deeb A. Rectus sheath block for postoperative analgesia in patients with mesenteric vascular occlusion undergoing laparotomy: A randomized single-blinded study. Anesth Essays Res. 2016 Sep-Dec;10(3):516-520. doi: 10.4103/0259-1162.179315. |
| 31590939 | Result | Cibelli M, Brodier EA, Smith FG. Pectoralis-Intercostal-Rectus Sheath (PIRS) Plane Block With Catheters. A New Technique to Provide Analgesia in Cardiac Surgery. J Cardiothorac Vasc Anesth. 2020 Mar;34(3):846-847. doi: 10.1053/j.jvca.2019.09.014. Epub 2019 Sep 18. No abstract available. |
| 35936156 | Result | Everett L, Davis TA, Deshpande SP, Mondal S. Implementation of Bilateral Rectus Sheath Blocks in Conjunction With Transversus Thoracis Plane and Pectointercostal Fascial Blocks for Immediate Postoperative Analgesia After Cardiac Surgery. Cureus. 2022 Jul 5;14(7):e26592. doi: 10.7759/cureus.26592. eCollection 2022 Jul. |
| 38876800 | Derived | Strumia A, Pascarella G, Sarubbi D, Di Pumpo A, Costa F, Conti MC, Rizzo S, Stifano M, Mortini L, Cassibba A, Schiavoni L, Mattei A, Ruggiero A, Agro FE, Carassiti M, Cataldo R. Rectus sheath block added to parasternal block may improve postoperative pain control and respiratory performance after cardiac surgery: a superiority single-blinded randomized controlled clinical trial. Reg Anesth Pain Med. 2025 Sep 4;50(9):712-718. doi: 10.1136/rapm-2024-105430. |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |