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The impact of PECS II blockade in patients undergoing minimally invasive cardiac surgery—a prospective, randomized, controlled, and triple-blinded trial

BACKGROUND: Classic neuraxial techniques, such as thoracic epidural anesthesia, or alternative approaches like the paravertebral block, are not indicated in cardiac surgery due to increased bleeding risk. To provide satisfactory analgesia without the need for excessive opioid use, novel ultrasound t...

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Autores principales: Hoerner, Elisabeth, Stundner, Ottokar, Naegele, Felix, Fiala, Anna, Bonaros, Nikolaos, Mair, Peter, Holfeld, Johannes, Gasteiger, Lukas
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10476350/
https://www.ncbi.nlm.nih.gov/pubmed/37667362
http://dx.doi.org/10.1186/s13063-023-07530-7
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author Hoerner, Elisabeth
Stundner, Ottokar
Naegele, Felix
Fiala, Anna
Bonaros, Nikolaos
Mair, Peter
Holfeld, Johannes
Gasteiger, Lukas
author_facet Hoerner, Elisabeth
Stundner, Ottokar
Naegele, Felix
Fiala, Anna
Bonaros, Nikolaos
Mair, Peter
Holfeld, Johannes
Gasteiger, Lukas
author_sort Hoerner, Elisabeth
collection PubMed
description BACKGROUND: Classic neuraxial techniques, such as thoracic epidural anesthesia, or alternative approaches like the paravertebral block, are not indicated in cardiac surgery due to increased bleeding risk. To provide satisfactory analgesia without the need for excessive opioid use, novel ultrasound techniques gained popularity and are of growing interest. The pectoralis nerve block II (PECS II) has been shown to provide good postoperative analgesia in modified radical mastectomy and might also be suitable for minimally invasive cardiac surgery. METHODS: In a single center, prospective, triple-blinded, two-group randomized trial, 60 patients undergoing elective, unilateral minimal invasive cardiac surgery will be randomized to receive a PECS II with 30 ml of ropivacaine 0.5% (intervention group) or sodium chloride 0.9% (placebo group). The primary outcome parameter is the overall opioid demand given as intravenous morphine milligram equivalents (MME) during the first 24 h after extubation. Secondary endpoints are the visual analog scale (VAS) 2, 4, 6, 8, 12, and 24 h after extubation, the Overall Benefit of Analgesia Score (OBAS) after 24 h, the interval until extubation, and intensive care unit (ICU) discharge within 24 h, as well as the length of hospital stay (LOS). DISCUSSION: This prospective randomized, controlled, and triple-blinded trial aims to assess if a PECS II with ropivacaine 0.5% helps to decrease the opioid demand in the first 24 h and increases postoperative pain control after minimally invasive cardiac surgery. TRIAL REGISTRATION: www.clinicaltrialsregister.eu; EudraCT Nr: 2021–005452-11; Lukas Gasteiger MD, November 18, 2021.
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spelling pubmed-104763502023-09-05 The impact of PECS II blockade in patients undergoing minimally invasive cardiac surgery—a prospective, randomized, controlled, and triple-blinded trial Hoerner, Elisabeth Stundner, Ottokar Naegele, Felix Fiala, Anna Bonaros, Nikolaos Mair, Peter Holfeld, Johannes Gasteiger, Lukas Trials Study Protocol BACKGROUND: Classic neuraxial techniques, such as thoracic epidural anesthesia, or alternative approaches like the paravertebral block, are not indicated in cardiac surgery due to increased bleeding risk. To provide satisfactory analgesia without the need for excessive opioid use, novel ultrasound techniques gained popularity and are of growing interest. The pectoralis nerve block II (PECS II) has been shown to provide good postoperative analgesia in modified radical mastectomy and might also be suitable for minimally invasive cardiac surgery. METHODS: In a single center, prospective, triple-blinded, two-group randomized trial, 60 patients undergoing elective, unilateral minimal invasive cardiac surgery will be randomized to receive a PECS II with 30 ml of ropivacaine 0.5% (intervention group) or sodium chloride 0.9% (placebo group). The primary outcome parameter is the overall opioid demand given as intravenous morphine milligram equivalents (MME) during the first 24 h after extubation. Secondary endpoints are the visual analog scale (VAS) 2, 4, 6, 8, 12, and 24 h after extubation, the Overall Benefit of Analgesia Score (OBAS) after 24 h, the interval until extubation, and intensive care unit (ICU) discharge within 24 h, as well as the length of hospital stay (LOS). DISCUSSION: This prospective randomized, controlled, and triple-blinded trial aims to assess if a PECS II with ropivacaine 0.5% helps to decrease the opioid demand in the first 24 h and increases postoperative pain control after minimally invasive cardiac surgery. TRIAL REGISTRATION: www.clinicaltrialsregister.eu; EudraCT Nr: 2021–005452-11; Lukas Gasteiger MD, November 18, 2021. BioMed Central 2023-09-04 /pmc/articles/PMC10476350/ /pubmed/37667362 http://dx.doi.org/10.1186/s13063-023-07530-7 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Hoerner, Elisabeth
Stundner, Ottokar
Naegele, Felix
Fiala, Anna
Bonaros, Nikolaos
Mair, Peter
Holfeld, Johannes
Gasteiger, Lukas
The impact of PECS II blockade in patients undergoing minimally invasive cardiac surgery—a prospective, randomized, controlled, and triple-blinded trial
title The impact of PECS II blockade in patients undergoing minimally invasive cardiac surgery—a prospective, randomized, controlled, and triple-blinded trial
title_full The impact of PECS II blockade in patients undergoing minimally invasive cardiac surgery—a prospective, randomized, controlled, and triple-blinded trial
title_fullStr The impact of PECS II blockade in patients undergoing minimally invasive cardiac surgery—a prospective, randomized, controlled, and triple-blinded trial
title_full_unstemmed The impact of PECS II blockade in patients undergoing minimally invasive cardiac surgery—a prospective, randomized, controlled, and triple-blinded trial
title_short The impact of PECS II blockade in patients undergoing minimally invasive cardiac surgery—a prospective, randomized, controlled, and triple-blinded trial
title_sort impact of pecs ii blockade in patients undergoing minimally invasive cardiac surgery—a prospective, randomized, controlled, and triple-blinded trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10476350/
https://www.ncbi.nlm.nih.gov/pubmed/37667362
http://dx.doi.org/10.1186/s13063-023-07530-7
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