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REDUCE trial: the effects of perineural dexamethasone on scalp nerve blocks for relief of postcraniotomy pain—a study protocol for a randomized controlled trial
BACKGROUND: Pain is common in the first 2 days after major craniotomy. Inadequate analgesia may lead to an increased risk of postoperative complications. Most pain following craniotomy arises from the pericranial muscles and soft tissues of the scalp. Scalp nerve blocks with local anesthesia seem to...
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/PMC8567555/ https://www.ncbi.nlm.nih.gov/pubmed/34736497 http://dx.doi.org/10.1186/s13063-021-05747-y |
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author | Zhao, Chunmei Jia, Zipu Shrestha, Niti Luo, Fang |
author_facet | Zhao, Chunmei Jia, Zipu Shrestha, Niti Luo, Fang |
author_sort | Zhao, Chunmei |
collection | PubMed |
description | BACKGROUND: Pain is common in the first 2 days after major craniotomy. Inadequate analgesia may lead to an increased risk of postoperative complications. Most pain following craniotomy arises from the pericranial muscles and soft tissues of the scalp. Scalp nerve blocks with local anesthesia seem to provide effective, safe, however, transient postoperative analgesia which does not seem to meet the requirements of craniotomy. Currently, peripheral dexamethasone has been observed to significantly prolong the duration of analgesia of nerve blocks (e.g., saphenous nerve block, adductor canal block, thoracic paravertebral block, brachial plexus nerve block). On the contrary, a study reported that perineural dexamethasone did not appear to prolong the analgesic time after supratentorial craniotomy. However, all patients in this study were given 24 mg of oral or intravenous dexamethasone regularly for at least 7 days during the perioperative period, which possibly masked the role of single local low doses of perineural dexamethasone. Therefore, the analgesic effect of single dexamethasone for scalp nerve blocks without the background of perioperative glucocorticoid deserves further clarification. METHODS: The REDUCE trial is a prospective, single-center, parallel-group randomized controlled trial involving a total of 156 adults scheduled for elective craniotomy with general anesthesia. Patients will be randomly divided among two groups: the control group (n = 78) will receive scalp nerve blocks with 0.5% bupivacaine, plus normal saline with epinephrine at 1:200,000; the DEX(4mg) group (n = 78) will receive scalp nerve blocks with 0.5% bupivacaine, plus 4 mg dexamethasone with epinephrine at 1:200,000. The primary outcome will be the duration of analgesia, defined as the time between the performance of the block and the first analgesic request. DISCUSSION: The REDUCE trial aims to further assess the analgesic effect of single dexamethasone as an adjuvant to scalp nerve blocks for relief of postcraniotomy pain without the background of perioperative glucocorticoid. TRIAL REGISTRATION: ClinicalTrials.govNCT04648358. Registered on November 30, 2020. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05747-y. |
format | Online Article Text |
id | pubmed-8567555 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-85675552021-11-04 REDUCE trial: the effects of perineural dexamethasone on scalp nerve blocks for relief of postcraniotomy pain—a study protocol for a randomized controlled trial Zhao, Chunmei Jia, Zipu Shrestha, Niti Luo, Fang Trials Study Protocol BACKGROUND: Pain is common in the first 2 days after major craniotomy. Inadequate analgesia may lead to an increased risk of postoperative complications. Most pain following craniotomy arises from the pericranial muscles and soft tissues of the scalp. Scalp nerve blocks with local anesthesia seem to provide effective, safe, however, transient postoperative analgesia which does not seem to meet the requirements of craniotomy. Currently, peripheral dexamethasone has been observed to significantly prolong the duration of analgesia of nerve blocks (e.g., saphenous nerve block, adductor canal block, thoracic paravertebral block, brachial plexus nerve block). On the contrary, a study reported that perineural dexamethasone did not appear to prolong the analgesic time after supratentorial craniotomy. However, all patients in this study were given 24 mg of oral or intravenous dexamethasone regularly for at least 7 days during the perioperative period, which possibly masked the role of single local low doses of perineural dexamethasone. Therefore, the analgesic effect of single dexamethasone for scalp nerve blocks without the background of perioperative glucocorticoid deserves further clarification. METHODS: The REDUCE trial is a prospective, single-center, parallel-group randomized controlled trial involving a total of 156 adults scheduled for elective craniotomy with general anesthesia. Patients will be randomly divided among two groups: the control group (n = 78) will receive scalp nerve blocks with 0.5% bupivacaine, plus normal saline with epinephrine at 1:200,000; the DEX(4mg) group (n = 78) will receive scalp nerve blocks with 0.5% bupivacaine, plus 4 mg dexamethasone with epinephrine at 1:200,000. The primary outcome will be the duration of analgesia, defined as the time between the performance of the block and the first analgesic request. DISCUSSION: The REDUCE trial aims to further assess the analgesic effect of single dexamethasone as an adjuvant to scalp nerve blocks for relief of postcraniotomy pain without the background of perioperative glucocorticoid. TRIAL REGISTRATION: ClinicalTrials.govNCT04648358. Registered on November 30, 2020. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05747-y. BioMed Central 2021-11-04 /pmc/articles/PMC8567555/ /pubmed/34736497 http://dx.doi.org/10.1186/s13063-021-05747-y Text en © The Author(s) 2021 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 Zhao, Chunmei Jia, Zipu Shrestha, Niti Luo, Fang REDUCE trial: the effects of perineural dexamethasone on scalp nerve blocks for relief of postcraniotomy pain—a study protocol for a randomized controlled trial |
title | REDUCE trial: the effects of perineural dexamethasone on scalp nerve blocks for relief of postcraniotomy pain—a study protocol for a randomized controlled trial |
title_full | REDUCE trial: the effects of perineural dexamethasone on scalp nerve blocks for relief of postcraniotomy pain—a study protocol for a randomized controlled trial |
title_fullStr | REDUCE trial: the effects of perineural dexamethasone on scalp nerve blocks for relief of postcraniotomy pain—a study protocol for a randomized controlled trial |
title_full_unstemmed | REDUCE trial: the effects of perineural dexamethasone on scalp nerve blocks for relief of postcraniotomy pain—a study protocol for a randomized controlled trial |
title_short | REDUCE trial: the effects of perineural dexamethasone on scalp nerve blocks for relief of postcraniotomy pain—a study protocol for a randomized controlled trial |
title_sort | reduce trial: the effects of perineural dexamethasone on scalp nerve blocks for relief of postcraniotomy pain—a study protocol for a randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8567555/ https://www.ncbi.nlm.nih.gov/pubmed/34736497 http://dx.doi.org/10.1186/s13063-021-05747-y |
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