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Ultrasound-guided erector spinae plane block versus thoracic paravertebral block on postoperative analgesia after laparoscopic nephroureterectomy: study protocol of a randomized, double-blinded, non-inferiority design trial
INTRODUCTION: Erector spinae plane block (ESPB) is a novel inter-fascial plane block, which is applied more and more in postoperative pain control, especially in chest surgery. Regional block is advocated in order to decrease opioid consumption and improve analgesia in urological surgery. Therefore,...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8022408/ https://www.ncbi.nlm.nih.gov/pubmed/33823924 http://dx.doi.org/10.1186/s13063-021-05173-0 |
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author | Xu, Zhen-Zhen Li, Xue Zhang, Zhen Liu, Zheng-Ye Song, Lin-Lin Li, Xue-Ying Zhang, Hong |
author_facet | Xu, Zhen-Zhen Li, Xue Zhang, Zhen Liu, Zheng-Ye Song, Lin-Lin Li, Xue-Ying Zhang, Hong |
author_sort | Xu, Zhen-Zhen |
collection | PubMed |
description | INTRODUCTION: Erector spinae plane block (ESPB) is a novel inter-fascial plane block, which is applied more and more in postoperative pain control, especially in chest surgery. Regional block is advocated in order to decrease opioid consumption and improve analgesia in urological surgery. Therefore, we aimed to explore whether ESPB would have similar analgesia compared with thoracic paravertebral block (TPVB) in laparoscopic nephroureterectomy. METHODS AND ANALYSIS: This prospective, randomized, double-blinded, non-inferiority trial will enroll 166 patients undergoing laparoscopic nephroureterectomy. Participants will be randomly assigned 1:1 into receiving ESPB or TPVB before surgery. Both ultrasound-guided ESPB and TPVB will be performed with an injection of 0.375% ropivacaine 0.4 ml/kg before anesthesia induction. Standardized patients controlled intravenous analgesia (PCIA) will be applied for each patient. The primary endpoint is the joint of cumulative 24 h opioid (sufentanil) consumption and average pain score via numeric rating scale (NRS) at 24 h after surgery. Secondary endpoints include rescued analgesic demand, cumulative opioid consumption, and pain NRS scores at different preset timepoints within 48 h after surgery. Other predefined outcomes include clinical features of blockage, quality of recovery, subjective sleep quality, time to ambulation and diet, and adverse events, as well as length of stay in hospital and anesthesia cost. DISCUSSION: Previous studies investigating the analgesic efficacy of ESPB only concentrated on a single endpoint for postoperative pain evaluation, while studies focusing on the direct comparison between ESPB and TPVB in urological surgery are still lacking. Our study is the first trial in non-inferiority design of comparing ESPB and TPVB in patient undergoing laparoscopic nephroureterectomy, and the primary outcome is the joint endpoint of opioid consumption and pain NRS score. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR 2000031916. Registered on 14 April 2020. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05173-0. |
format | Online Article Text |
id | pubmed-8022408 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-80224082021-04-07 Ultrasound-guided erector spinae plane block versus thoracic paravertebral block on postoperative analgesia after laparoscopic nephroureterectomy: study protocol of a randomized, double-blinded, non-inferiority design trial Xu, Zhen-Zhen Li, Xue Zhang, Zhen Liu, Zheng-Ye Song, Lin-Lin Li, Xue-Ying Zhang, Hong Trials Study Protocol INTRODUCTION: Erector spinae plane block (ESPB) is a novel inter-fascial plane block, which is applied more and more in postoperative pain control, especially in chest surgery. Regional block is advocated in order to decrease opioid consumption and improve analgesia in urological surgery. Therefore, we aimed to explore whether ESPB would have similar analgesia compared with thoracic paravertebral block (TPVB) in laparoscopic nephroureterectomy. METHODS AND ANALYSIS: This prospective, randomized, double-blinded, non-inferiority trial will enroll 166 patients undergoing laparoscopic nephroureterectomy. Participants will be randomly assigned 1:1 into receiving ESPB or TPVB before surgery. Both ultrasound-guided ESPB and TPVB will be performed with an injection of 0.375% ropivacaine 0.4 ml/kg before anesthesia induction. Standardized patients controlled intravenous analgesia (PCIA) will be applied for each patient. The primary endpoint is the joint of cumulative 24 h opioid (sufentanil) consumption and average pain score via numeric rating scale (NRS) at 24 h after surgery. Secondary endpoints include rescued analgesic demand, cumulative opioid consumption, and pain NRS scores at different preset timepoints within 48 h after surgery. Other predefined outcomes include clinical features of blockage, quality of recovery, subjective sleep quality, time to ambulation and diet, and adverse events, as well as length of stay in hospital and anesthesia cost. DISCUSSION: Previous studies investigating the analgesic efficacy of ESPB only concentrated on a single endpoint for postoperative pain evaluation, while studies focusing on the direct comparison between ESPB and TPVB in urological surgery are still lacking. Our study is the first trial in non-inferiority design of comparing ESPB and TPVB in patient undergoing laparoscopic nephroureterectomy, and the primary outcome is the joint endpoint of opioid consumption and pain NRS score. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR 2000031916. Registered on 14 April 2020. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05173-0. BioMed Central 2021-04-06 /pmc/articles/PMC8022408/ /pubmed/33823924 http://dx.doi.org/10.1186/s13063-021-05173-0 Text en © The Author(s) 2021 Open AccessThis 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/. The Creative Commons Public Domain Dedication waiver (http://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 Xu, Zhen-Zhen Li, Xue Zhang, Zhen Liu, Zheng-Ye Song, Lin-Lin Li, Xue-Ying Zhang, Hong Ultrasound-guided erector spinae plane block versus thoracic paravertebral block on postoperative analgesia after laparoscopic nephroureterectomy: study protocol of a randomized, double-blinded, non-inferiority design trial |
title | Ultrasound-guided erector spinae plane block versus thoracic paravertebral block on postoperative analgesia after laparoscopic nephroureterectomy: study protocol of a randomized, double-blinded, non-inferiority design trial |
title_full | Ultrasound-guided erector spinae plane block versus thoracic paravertebral block on postoperative analgesia after laparoscopic nephroureterectomy: study protocol of a randomized, double-blinded, non-inferiority design trial |
title_fullStr | Ultrasound-guided erector spinae plane block versus thoracic paravertebral block on postoperative analgesia after laparoscopic nephroureterectomy: study protocol of a randomized, double-blinded, non-inferiority design trial |
title_full_unstemmed | Ultrasound-guided erector spinae plane block versus thoracic paravertebral block on postoperative analgesia after laparoscopic nephroureterectomy: study protocol of a randomized, double-blinded, non-inferiority design trial |
title_short | Ultrasound-guided erector spinae plane block versus thoracic paravertebral block on postoperative analgesia after laparoscopic nephroureterectomy: study protocol of a randomized, double-blinded, non-inferiority design trial |
title_sort | ultrasound-guided erector spinae plane block versus thoracic paravertebral block on postoperative analgesia after laparoscopic nephroureterectomy: study protocol of a randomized, double-blinded, non-inferiority design trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8022408/ https://www.ncbi.nlm.nih.gov/pubmed/33823924 http://dx.doi.org/10.1186/s13063-021-05173-0 |
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