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Randomized control trial of ultrasound-guided erector spinae block versus shoulder periarticular anesthetic infiltration for pain control after arthroscopic shoulder surgery: Study protocol clinical trial (SPIRIT compliant)
INTRODUCTION: Moderate to severe postoperative pain and associated opioid use may interfere with patients’ well-being and course of recovery. Regional anesthetic techniques provide an opportunity for opioid sparing and improved patient outcomes. A new regional technique called the erector spinae pla...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Wolters Kluwer Health
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7220186/ https://www.ncbi.nlm.nih.gov/pubmed/32282729 http://dx.doi.org/10.1097/MD.0000000000019721 |
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author | Czuczman, Mark Shanthanna, Harsha Alolabi, Bashar Moisiuk, Peter O’Hare, Turlough Khan, Moin Forero, Mauricio Davis, Kimberly Moro, Jaydeep Vanniyasingam, Thuva Thabane, Lehana |
author_facet | Czuczman, Mark Shanthanna, Harsha Alolabi, Bashar Moisiuk, Peter O’Hare, Turlough Khan, Moin Forero, Mauricio Davis, Kimberly Moro, Jaydeep Vanniyasingam, Thuva Thabane, Lehana |
author_sort | Czuczman, Mark |
collection | PubMed |
description | INTRODUCTION: Moderate to severe postoperative pain and associated opioid use may interfere with patients’ well-being and course of recovery. Regional anesthetic techniques provide an opportunity for opioid sparing and improved patient outcomes. A new regional technique called the erector spinae plane (ESP) block has the potential to provide effective analgesia after shoulder arthroscopy with minimal risks and decreased opioid consumption. Our primary objective is to determine whether, in patients who undergo arthroscopic shoulder surgery, a preoperative ESP block reduces pain scores as compared to periarticular infiltration at the end of surgery. Additionally, we will also examine other factors such as opioid consumption, sensory block, adverse events, patient satisfaction, and persistent pain. METHODS: This is a 2-arm, single-center, parallel-design, double-blind randomized controlled trial of 60 patients undergoing arthroscopic shoulder surgery. Eligible patients will be recruited in the preoperative clinic. Using a computer-generated randomization, with a 1:1 allocation ratio, patients will be randomized to either the ESP or periarticular infiltration group. Patients will be followed in hospital in the postanesthesia care unit, at 24 hours, and at 1 month. The study with be analyzed as intention-to-treat. DISCUSSION: This study will inform an evidence-based choice in recommending ESP block for shoulder arthroscopy, as well as providing safety data. The merits of the study include its double dummy blinding to minimize observer bias, and its assessment of patient important outcomes, including pain scores, opioid consumption, and patient satisfaction. This study will also help provide an estimate of the incidence of side effects and complications of the ESP block. TRIAL REGISTRATION NUMBER: NCT03691922; Recruited Date of registration: October 2, 2018. |
format | Online Article Text |
id | pubmed-7220186 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Wolters Kluwer Health |
record_format | MEDLINE/PubMed |
spelling | pubmed-72201862020-06-15 Randomized control trial of ultrasound-guided erector spinae block versus shoulder periarticular anesthetic infiltration for pain control after arthroscopic shoulder surgery: Study protocol clinical trial (SPIRIT compliant) Czuczman, Mark Shanthanna, Harsha Alolabi, Bashar Moisiuk, Peter O’Hare, Turlough Khan, Moin Forero, Mauricio Davis, Kimberly Moro, Jaydeep Vanniyasingam, Thuva Thabane, Lehana Medicine (Baltimore) 3300 INTRODUCTION: Moderate to severe postoperative pain and associated opioid use may interfere with patients’ well-being and course of recovery. Regional anesthetic techniques provide an opportunity for opioid sparing and improved patient outcomes. A new regional technique called the erector spinae plane (ESP) block has the potential to provide effective analgesia after shoulder arthroscopy with minimal risks and decreased opioid consumption. Our primary objective is to determine whether, in patients who undergo arthroscopic shoulder surgery, a preoperative ESP block reduces pain scores as compared to periarticular infiltration at the end of surgery. Additionally, we will also examine other factors such as opioid consumption, sensory block, adverse events, patient satisfaction, and persistent pain. METHODS: This is a 2-arm, single-center, parallel-design, double-blind randomized controlled trial of 60 patients undergoing arthroscopic shoulder surgery. Eligible patients will be recruited in the preoperative clinic. Using a computer-generated randomization, with a 1:1 allocation ratio, patients will be randomized to either the ESP or periarticular infiltration group. Patients will be followed in hospital in the postanesthesia care unit, at 24 hours, and at 1 month. The study with be analyzed as intention-to-treat. DISCUSSION: This study will inform an evidence-based choice in recommending ESP block for shoulder arthroscopy, as well as providing safety data. The merits of the study include its double dummy blinding to minimize observer bias, and its assessment of patient important outcomes, including pain scores, opioid consumption, and patient satisfaction. This study will also help provide an estimate of the incidence of side effects and complications of the ESP block. TRIAL REGISTRATION NUMBER: NCT03691922; Recruited Date of registration: October 2, 2018. Wolters Kluwer Health 2020-04-10 /pmc/articles/PMC7220186/ /pubmed/32282729 http://dx.doi.org/10.1097/MD.0000000000019721 Text en Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc. http://creativecommons.org/licenses/by/4.0 This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0 |
spellingShingle | 3300 Czuczman, Mark Shanthanna, Harsha Alolabi, Bashar Moisiuk, Peter O’Hare, Turlough Khan, Moin Forero, Mauricio Davis, Kimberly Moro, Jaydeep Vanniyasingam, Thuva Thabane, Lehana Randomized control trial of ultrasound-guided erector spinae block versus shoulder periarticular anesthetic infiltration for pain control after arthroscopic shoulder surgery: Study protocol clinical trial (SPIRIT compliant) |
title | Randomized control trial of ultrasound-guided erector spinae block versus shoulder periarticular anesthetic infiltration for pain control after arthroscopic shoulder surgery: Study protocol clinical trial (SPIRIT compliant) |
title_full | Randomized control trial of ultrasound-guided erector spinae block versus shoulder periarticular anesthetic infiltration for pain control after arthroscopic shoulder surgery: Study protocol clinical trial (SPIRIT compliant) |
title_fullStr | Randomized control trial of ultrasound-guided erector spinae block versus shoulder periarticular anesthetic infiltration for pain control after arthroscopic shoulder surgery: Study protocol clinical trial (SPIRIT compliant) |
title_full_unstemmed | Randomized control trial of ultrasound-guided erector spinae block versus shoulder periarticular anesthetic infiltration for pain control after arthroscopic shoulder surgery: Study protocol clinical trial (SPIRIT compliant) |
title_short | Randomized control trial of ultrasound-guided erector spinae block versus shoulder periarticular anesthetic infiltration for pain control after arthroscopic shoulder surgery: Study protocol clinical trial (SPIRIT compliant) |
title_sort | randomized control trial of ultrasound-guided erector spinae block versus shoulder periarticular anesthetic infiltration for pain control after arthroscopic shoulder surgery: study protocol clinical trial (spirit compliant) |
topic | 3300 |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7220186/ https://www.ncbi.nlm.nih.gov/pubmed/32282729 http://dx.doi.org/10.1097/MD.0000000000019721 |
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