Cargando…

Comparison of erector spinae plane and paravertebral nerve blocks for postoperative analgesia in children after the Nuss procedure: study protocol for a randomized controlled non-inferiority clinical trial

BACKGROUND: Thoracic paravertebral block (TPVB) is a widely advocated regional technique for alleviating postoperative pain in children undergoing elective pectus excavatum repair. However, this technique is associated with some undesirable adverse events. Recently, the erector spinae plane block (E...

Descripción completa

Detalles Bibliográficos
Autores principales: Xu, Min, Zhang, Guangchao, Gong, Jingxuan, Yang, Jing
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8842927/
https://www.ncbi.nlm.nih.gov/pubmed/35164831
http://dx.doi.org/10.1186/s13063-022-06044-y
_version_ 1784651147811749888
author Xu, Min
Zhang, Guangchao
Gong, Jingxuan
Yang, Jing
author_facet Xu, Min
Zhang, Guangchao
Gong, Jingxuan
Yang, Jing
author_sort Xu, Min
collection PubMed
description BACKGROUND: Thoracic paravertebral block (TPVB) is a widely advocated regional technique for alleviating postoperative pain in children undergoing elective pectus excavatum repair. However, this technique is associated with some undesirable adverse events. Recently, the erector spinae plane block (ESPB) has been introduced as a practical alternative to the TPVB in thoracic surgery. This interfascial regional anesthesia technique interrupts pain sensation by injecting local anesthetics between the muscular layers of the thoracic wall. Several case series described it as an effective pain management technique following pectus excavatum repair. Therefore, this trial is designed to test the hypothesis that ESPB is non-inferior to TPVB in postoperative pain control after pectus excavatum repair. METHODS: This is a prospective randomized double-blind non-inferiority trial. A total of 40 patients aged 4 to 18 years undergoing Nuss surgery will be randomly assigned to receive pain treatment with either ESPB or TPVB. All patients will receive additional systemic multimodal analgesia with an intravenous patient-controlled analgesia pump and acetaminophen. The primary outcome is the pain intensity at rest, 24 h postoperatively. Secondary outcomes include accumulated morphine-equivalent consumption, postoperative pain scores, emergence agitation incidence, time of the first mobilization, time to first rescue analgesia, complications related to pain treatment, and morphine-related adverse events. DISCUSSION: This will the first randomized controlled trial to compare ESPB with TPVB for analgesia after pectus excavatum repair. This trial aims to provide important clinical evidence to elaborate on the analgesic mechanism of ESPB in children. TRIAL REGISTRATION: ClinicalTrials.govNCT05034601. This trial was prospectively registered. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06044-y.
format Online
Article
Text
id pubmed-8842927
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-88429272022-02-16 Comparison of erector spinae plane and paravertebral nerve blocks for postoperative analgesia in children after the Nuss procedure: study protocol for a randomized controlled non-inferiority clinical trial Xu, Min Zhang, Guangchao Gong, Jingxuan Yang, Jing Trials Study Protocol BACKGROUND: Thoracic paravertebral block (TPVB) is a widely advocated regional technique for alleviating postoperative pain in children undergoing elective pectus excavatum repair. However, this technique is associated with some undesirable adverse events. Recently, the erector spinae plane block (ESPB) has been introduced as a practical alternative to the TPVB in thoracic surgery. This interfascial regional anesthesia technique interrupts pain sensation by injecting local anesthetics between the muscular layers of the thoracic wall. Several case series described it as an effective pain management technique following pectus excavatum repair. Therefore, this trial is designed to test the hypothesis that ESPB is non-inferior to TPVB in postoperative pain control after pectus excavatum repair. METHODS: This is a prospective randomized double-blind non-inferiority trial. A total of 40 patients aged 4 to 18 years undergoing Nuss surgery will be randomly assigned to receive pain treatment with either ESPB or TPVB. All patients will receive additional systemic multimodal analgesia with an intravenous patient-controlled analgesia pump and acetaminophen. The primary outcome is the pain intensity at rest, 24 h postoperatively. Secondary outcomes include accumulated morphine-equivalent consumption, postoperative pain scores, emergence agitation incidence, time of the first mobilization, time to first rescue analgesia, complications related to pain treatment, and morphine-related adverse events. DISCUSSION: This will the first randomized controlled trial to compare ESPB with TPVB for analgesia after pectus excavatum repair. This trial aims to provide important clinical evidence to elaborate on the analgesic mechanism of ESPB in children. TRIAL REGISTRATION: ClinicalTrials.govNCT05034601. This trial was prospectively registered. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06044-y. BioMed Central 2022-02-14 /pmc/articles/PMC8842927/ /pubmed/35164831 http://dx.doi.org/10.1186/s13063-022-06044-y Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/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/ (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
Xu, Min
Zhang, Guangchao
Gong, Jingxuan
Yang, Jing
Comparison of erector spinae plane and paravertebral nerve blocks for postoperative analgesia in children after the Nuss procedure: study protocol for a randomized controlled non-inferiority clinical trial
title Comparison of erector spinae plane and paravertebral nerve blocks for postoperative analgesia in children after the Nuss procedure: study protocol for a randomized controlled non-inferiority clinical trial
title_full Comparison of erector spinae plane and paravertebral nerve blocks for postoperative analgesia in children after the Nuss procedure: study protocol for a randomized controlled non-inferiority clinical trial
title_fullStr Comparison of erector spinae plane and paravertebral nerve blocks for postoperative analgesia in children after the Nuss procedure: study protocol for a randomized controlled non-inferiority clinical trial
title_full_unstemmed Comparison of erector spinae plane and paravertebral nerve blocks for postoperative analgesia in children after the Nuss procedure: study protocol for a randomized controlled non-inferiority clinical trial
title_short Comparison of erector spinae plane and paravertebral nerve blocks for postoperative analgesia in children after the Nuss procedure: study protocol for a randomized controlled non-inferiority clinical trial
title_sort comparison of erector spinae plane and paravertebral nerve blocks for postoperative analgesia in children after the nuss procedure: study protocol for a randomized controlled non-inferiority clinical trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8842927/
https://www.ncbi.nlm.nih.gov/pubmed/35164831
http://dx.doi.org/10.1186/s13063-022-06044-y
work_keys_str_mv AT xumin comparisonoferectorspinaeplaneandparavertebralnerveblocksforpostoperativeanalgesiainchildrenafterthenussprocedurestudyprotocolforarandomizedcontrollednoninferiorityclinicaltrial
AT zhangguangchao comparisonoferectorspinaeplaneandparavertebralnerveblocksforpostoperativeanalgesiainchildrenafterthenussprocedurestudyprotocolforarandomizedcontrollednoninferiorityclinicaltrial
AT gongjingxuan comparisonoferectorspinaeplaneandparavertebralnerveblocksforpostoperativeanalgesiainchildrenafterthenussprocedurestudyprotocolforarandomizedcontrollednoninferiorityclinicaltrial
AT yangjing comparisonoferectorspinaeplaneandparavertebralnerveblocksforpostoperativeanalgesiainchildrenafterthenussprocedurestudyprotocolforarandomizedcontrollednoninferiorityclinicaltrial