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The acupoint herbal plaster for the prevention and treatment of postoperative nausea and vomiting after PLIF with general anesthesia: study protocol for a multicenter randomized controlled trial

BACKGROUND: Postoperative nausea and vomiting (PONV) are common in posterior lumbar intervertebral fusion (PLIF) patients undergoing general anesthesia. The previous clinical observation has shown that a traditional acupoint herbal plaster (AHP) is beneficial to patients with PONV. This trial aims t...

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Autores principales: Xu, Huiqing, Wei, Xu, Zhang, Ranxing, Li, Ling, Zhang, Zhijun, Jia, Ruo, Zhang, Xiaofei, Gao, Xiumei, Dong, Xicheng, Pan, Junjun
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7821521/
https://www.ncbi.nlm.nih.gov/pubmed/33482878
http://dx.doi.org/10.1186/s13063-021-05037-7
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author Xu, Huiqing
Wei, Xu
Zhang, Ranxing
Li, Ling
Zhang, Zhijun
Jia, Ruo
Zhang, Xiaofei
Gao, Xiumei
Dong, Xicheng
Pan, Junjun
author_facet Xu, Huiqing
Wei, Xu
Zhang, Ranxing
Li, Ling
Zhang, Zhijun
Jia, Ruo
Zhang, Xiaofei
Gao, Xiumei
Dong, Xicheng
Pan, Junjun
author_sort Xu, Huiqing
collection PubMed
description BACKGROUND: Postoperative nausea and vomiting (PONV) are common in posterior lumbar intervertebral fusion (PLIF) patients undergoing general anesthesia. The previous clinical observation has shown that a traditional acupoint herbal plaster (AHP) is beneficial to patients with PONV. This trial aims to assess the effect of the AHP for the prevention and treatment of PONV after PLIF in patients with general anesthesia. METHODS: A multicenter, parallel, randomized controlled trial (RCT) will be conducted. A total of 166 participants will be randomized to either a treatment group receiving an AHP or a control groups receiving an acupoint placebo plaster (APP) in a 1:1 ratio. The primary outcomes are the first occurrence and frequency of nausea and vomiting. The secondary outcomes include the severity grading of nausea and vomiting using a visual analog scale (VAS) measurement system, quality of life, and serological indicators. The safety evaluation is mainly about adverse events and skin reactions’ observation. Assessments will be carried out at the baseline, day 1, and day 2 (the end of the intervention). The central randomization system in the clinical trial (http://124.205.181.142:8082/xwtf/) will be used to conduct random allocation. DISCUSSION: This scientific methodology design of the trial is expected to provide clinical evidence to support the AHP for the prevention and treatment of PONV. TRIAL REGISTRATION: This study is retrospectively registered with the Chinese Clinical Trial Registry (http://www.chictr.org.cn) on 19 April 2018. ID: ChiCTR1800015768.
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spelling pubmed-78215212021-01-22 The acupoint herbal plaster for the prevention and treatment of postoperative nausea and vomiting after PLIF with general anesthesia: study protocol for a multicenter randomized controlled trial Xu, Huiqing Wei, Xu Zhang, Ranxing Li, Ling Zhang, Zhijun Jia, Ruo Zhang, Xiaofei Gao, Xiumei Dong, Xicheng Pan, Junjun Trials Study Protocol BACKGROUND: Postoperative nausea and vomiting (PONV) are common in posterior lumbar intervertebral fusion (PLIF) patients undergoing general anesthesia. The previous clinical observation has shown that a traditional acupoint herbal plaster (AHP) is beneficial to patients with PONV. This trial aims to assess the effect of the AHP for the prevention and treatment of PONV after PLIF in patients with general anesthesia. METHODS: A multicenter, parallel, randomized controlled trial (RCT) will be conducted. A total of 166 participants will be randomized to either a treatment group receiving an AHP or a control groups receiving an acupoint placebo plaster (APP) in a 1:1 ratio. The primary outcomes are the first occurrence and frequency of nausea and vomiting. The secondary outcomes include the severity grading of nausea and vomiting using a visual analog scale (VAS) measurement system, quality of life, and serological indicators. The safety evaluation is mainly about adverse events and skin reactions’ observation. Assessments will be carried out at the baseline, day 1, and day 2 (the end of the intervention). The central randomization system in the clinical trial (http://124.205.181.142:8082/xwtf/) will be used to conduct random allocation. DISCUSSION: This scientific methodology design of the trial is expected to provide clinical evidence to support the AHP for the prevention and treatment of PONV. TRIAL REGISTRATION: This study is retrospectively registered with the Chinese Clinical Trial Registry (http://www.chictr.org.cn) on 19 April 2018. ID: ChiCTR1800015768. BioMed Central 2021-01-22 /pmc/articles/PMC7821521/ /pubmed/33482878 http://dx.doi.org/10.1186/s13063-021-05037-7 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, Huiqing
Wei, Xu
Zhang, Ranxing
Li, Ling
Zhang, Zhijun
Jia, Ruo
Zhang, Xiaofei
Gao, Xiumei
Dong, Xicheng
Pan, Junjun
The acupoint herbal plaster for the prevention and treatment of postoperative nausea and vomiting after PLIF with general anesthesia: study protocol for a multicenter randomized controlled trial
title The acupoint herbal plaster for the prevention and treatment of postoperative nausea and vomiting after PLIF with general anesthesia: study protocol for a multicenter randomized controlled trial
title_full The acupoint herbal plaster for the prevention and treatment of postoperative nausea and vomiting after PLIF with general anesthesia: study protocol for a multicenter randomized controlled trial
title_fullStr The acupoint herbal plaster for the prevention and treatment of postoperative nausea and vomiting after PLIF with general anesthesia: study protocol for a multicenter randomized controlled trial
title_full_unstemmed The acupoint herbal plaster for the prevention and treatment of postoperative nausea and vomiting after PLIF with general anesthesia: study protocol for a multicenter randomized controlled trial
title_short The acupoint herbal plaster for the prevention and treatment of postoperative nausea and vomiting after PLIF with general anesthesia: study protocol for a multicenter randomized controlled trial
title_sort acupoint herbal plaster for the prevention and treatment of postoperative nausea and vomiting after plif with general anesthesia: study protocol for a multicenter randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7821521/
https://www.ncbi.nlm.nih.gov/pubmed/33482878
http://dx.doi.org/10.1186/s13063-021-05037-7
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