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.

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
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引用次数: 1

Abstract

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.

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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。
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。
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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.
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