双侧三叉浅神经阻滞在消除垂体-蝶窦神经外科术后头痛方面并不比安慰剂更有效:一项前瞻性、随机、双盲临床试验。

IF 1.4 Q4 PHARMACOLOGY & PHARMACY Reviews on recent clinical trials Pub Date : 2023-01-01 DOI:10.2174/1574887118666230227113217
Una Srejic, Erik Litonius, Seema Gandhi, Pekka Talke, Oana Maties, Claas Siegmueller, Avic Magsaysay, Daniel Hasen, Sandeep Kunwar, Rahul Seth, Lizbeth Gibson, Philip Bickler
{"title":"双侧三叉浅神经阻滞在消除垂体-蝶窦神经外科术后头痛方面并不比安慰剂更有效:一项前瞻性、随机、双盲临床试验。","authors":"Una Srejic,&nbsp;Erik Litonius,&nbsp;Seema Gandhi,&nbsp;Pekka Talke,&nbsp;Oana Maties,&nbsp;Claas Siegmueller,&nbsp;Avic Magsaysay,&nbsp;Daniel Hasen,&nbsp;Sandeep Kunwar,&nbsp;Rahul Seth,&nbsp;Lizbeth Gibson,&nbsp;Philip Bickler","doi":"10.2174/1574887118666230227113217","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Pituitary neurosurgery executed via the transsphenoidal endonasal approach is commonly performed for pituitary adenomas. Reasons for prolonged hospital stay include postoperative headache and protracted nausea with or without vomiting. Bilateral superficial trigeminal nerve blocks of the supra-orbital V1 and infra-orbital V2 (SION) nerves performed intra-operatively as a regional anesthetic adjunct to general anesthesia were hypothesized to decrease 6 hours postoperative morphine PCA (patient-controlled analgesia) use by patients.</p><p><strong>Methods: </strong>Forty-nine patients, following induction of general anesthesia for their transsphenoidal surgery, were prospectively randomized in a double-blinded fashion to receive additional regional anesthesia as either a block (0.5% ropivacaine with epi 1:200,000) or placebo/sham (0.9% normal saline). The primary endpoint of the study was systemic morphine PCA opioid consumption by the two groups in the first 6-hours postoperatively. The secondary endpoints included (1) pain exposure experienced postoperatively, (2) incidence of postoperative nausea and vomiting, and (3) time to eligibility for PACU discharge.</p><p><strong>Results: </strong>Of the 49 patients that were enrolled, 3 patients were excluded due to protocol violations. Ultimately, there was no statistically significant difference between morphine PCA use in the 6 hours postoperatively between the block and placebo/sham groups. There was, however, a slight visual tendency in the block group for higher pain scores, morphine use p=0.046, and delayed PACU discharge. False discovery rate corrected comparisons at each time point and then revealed no statistically significant difference between the two groups. There were no differences between the two groups for secondary endpoints.</p><p><strong>Conclusion: </strong>It was found that a 6-hour postoperative headache after endoscopic trans-sphenoidal pituitary surgery likely has a more complicated mechanism involving more than the superficial trigeminovascular system and perhaps is neuro-modulated by other brain nuclei.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":null,"pages":null},"PeriodicalIF":1.4000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10514508/pdf/","citationCount":"1","resultStr":"{\"title\":\"Bilateral Superficial Trigeminal Nerve Blocks are not More Effective than a Placebo in Abolishing Post-operative Headache Pain in Pituitary Transsphenoidal Neurosurgery: A Prospective, Randomized, Doubleblinded Clinical Trial.\",\"authors\":\"Una Srejic,&nbsp;Erik Litonius,&nbsp;Seema Gandhi,&nbsp;Pekka Talke,&nbsp;Oana Maties,&nbsp;Claas Siegmueller,&nbsp;Avic Magsaysay,&nbsp;Daniel Hasen,&nbsp;Sandeep Kunwar,&nbsp;Rahul Seth,&nbsp;Lizbeth Gibson,&nbsp;Philip Bickler\",\"doi\":\"10.2174/1574887118666230227113217\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Pituitary neurosurgery executed via the transsphenoidal endonasal approach is commonly performed for pituitary adenomas. Reasons for prolonged hospital stay include postoperative headache and protracted nausea with or without vomiting. Bilateral superficial trigeminal nerve blocks of the supra-orbital V1 and infra-orbital V2 (SION) nerves performed intra-operatively as a regional anesthetic adjunct to general anesthesia were hypothesized to decrease 6 hours postoperative morphine PCA (patient-controlled analgesia) use by patients.</p><p><strong>Methods: </strong>Forty-nine patients, following induction of general anesthesia for their transsphenoidal surgery, were prospectively randomized in a double-blinded fashion to receive additional regional anesthesia as either a block (0.5% ropivacaine with epi 1:200,000) or placebo/sham (0.9% normal saline). The primary endpoint of the study was systemic morphine PCA opioid consumption by the two groups in the first 6-hours postoperatively. The secondary endpoints included (1) pain exposure experienced postoperatively, (2) incidence of postoperative nausea and vomiting, and (3) time to eligibility for PACU discharge.</p><p><strong>Results: </strong>Of the 49 patients that were enrolled, 3 patients were excluded due to protocol violations. Ultimately, there was no statistically significant difference between morphine PCA use in the 6 hours postoperatively between the block and placebo/sham groups. There was, however, a slight visual tendency in the block group for higher pain scores, morphine use p=0.046, and delayed PACU discharge. False discovery rate corrected comparisons at each time point and then revealed no statistically significant difference between the two groups. There were no differences between the two groups for secondary endpoints.</p><p><strong>Conclusion: </strong>It was found that a 6-hour postoperative headache after endoscopic trans-sphenoidal pituitary surgery likely has a more complicated mechanism involving more than the superficial trigeminovascular system and perhaps is neuro-modulated by other brain nuclei.</p>\",\"PeriodicalId\":21174,\"journal\":{\"name\":\"Reviews on recent clinical trials\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.4000,\"publicationDate\":\"2023-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10514508/pdf/\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Reviews on recent clinical trials\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.2174/1574887118666230227113217\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Reviews on recent clinical trials","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2174/1574887118666230227113217","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 1

摘要

背景:经蝶窦鼻内入路垂体神经外科手术是垂体腺瘤的常见手术方式。住院时间过长的原因包括术后头痛和伴有或不伴有呕吐的长期恶心。假设术中作为全身麻醉的辅助区域麻醉进行的眶上V1和眶下V2(SION)神经的双侧三叉浅神经阻滞可减少患者术后6小时吗啡PCA(患者控制镇痛)的使用。方法:49名患者在进行经蝶手术全身麻醉诱导后,前瞻性地以双盲方式随机接受额外的区域麻醉,作为阻滞(0.5%罗哌卡因和epi 1:200000)或安慰剂/假手术(0.9%生理盐水)。该研究的主要终点是两组在术后前6小时的全身吗啡PCA阿片类药物消耗量。次要终点包括(1)术后疼痛暴露,(2)术后恶心和呕吐的发生率,以及(3)符合PACU出院条件的时间。结果:在入选的49名患者中,有3名患者因违反方案而被排除在外。最终,阻断组和安慰剂/假手术组在术后6小时内吗啡PCA的使用之间没有统计学上的显著差异。然而,阻滞组有轻微的视觉倾向,疼痛评分较高,吗啡使用p=0.046,PACU出院延迟。错误发现率纠正了每个时间点的比较,然后显示两组之间没有统计学上的显著差异。两组在次要终点方面没有差异。结论:经蝶窦垂体内窥镜手术后6小时的头痛可能比浅表三叉神经血管系统有更复杂的机制,并且可能受到其他脑细胞核的神经调节。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

摘要图片

摘要图片

摘要图片

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
Bilateral Superficial Trigeminal Nerve Blocks are not More Effective than a Placebo in Abolishing Post-operative Headache Pain in Pituitary Transsphenoidal Neurosurgery: A Prospective, Randomized, Doubleblinded Clinical Trial.

Background: Pituitary neurosurgery executed via the transsphenoidal endonasal approach is commonly performed for pituitary adenomas. Reasons for prolonged hospital stay include postoperative headache and protracted nausea with or without vomiting. Bilateral superficial trigeminal nerve blocks of the supra-orbital V1 and infra-orbital V2 (SION) nerves performed intra-operatively as a regional anesthetic adjunct to general anesthesia were hypothesized to decrease 6 hours postoperative morphine PCA (patient-controlled analgesia) use by patients.

Methods: Forty-nine patients, following induction of general anesthesia for their transsphenoidal surgery, were prospectively randomized in a double-blinded fashion to receive additional regional anesthesia as either a block (0.5% ropivacaine with epi 1:200,000) or placebo/sham (0.9% normal saline). The primary endpoint of the study was systemic morphine PCA opioid consumption by the two groups in the first 6-hours postoperatively. The secondary endpoints included (1) pain exposure experienced postoperatively, (2) incidence of postoperative nausea and vomiting, and (3) time to eligibility for PACU discharge.

Results: Of the 49 patients that were enrolled, 3 patients were excluded due to protocol violations. Ultimately, there was no statistically significant difference between morphine PCA use in the 6 hours postoperatively between the block and placebo/sham groups. There was, however, a slight visual tendency in the block group for higher pain scores, morphine use p=0.046, and delayed PACU discharge. False discovery rate corrected comparisons at each time point and then revealed no statistically significant difference between the two groups. There were no differences between the two groups for secondary endpoints.

Conclusion: It was found that a 6-hour postoperative headache after endoscopic trans-sphenoidal pituitary surgery likely has a more complicated mechanism involving more than the superficial trigeminovascular system and perhaps is neuro-modulated by other brain nuclei.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Reviews on recent clinical trials
Reviews on recent clinical trials PHARMACOLOGY & PHARMACY-
CiteScore
3.10
自引率
5.30%
发文量
44
期刊介绍: Reviews on Recent Clinical Trials publishes frontier reviews on recent clinical trials of major importance. The journal"s aim is to publish the highest quality review articles in the field. Topics covered include: important Phase I – IV clinical trial studies, clinical investigations at all stages of development and therapeutics. The journal is essential reading for all researchers and clinicians involved in drug therapy and clinical trials.
期刊最新文献
Impact of Upright Position during the First Stage of Labour on Maternal Outcomes: A Randomized Controlled Trial. Study on Rapid, Quantitative, and Simultaneous Detection of Drug Residues and Immunoassay in Chickens. Impact of a Symbiotic Mixture on Moderate-to-severe Diverticular Disease of the Colon. Vanek's Tumour as a Rare Cause of Dyspeptic Syndrome in a Patient with Primary Biliary Cholangitis: A Case Report. Is There an Association between 5a Reductase Inhibitors and Metabolic Syndrome? A Narrative Review of the Literature.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1