1Department of Translational Medicine, Neurosurgery Unit, University of Ferrara.
2Department of Neurosurgery, University Hospital S. Anna of Ferrara; and.
Neurosurg Focus. 2023 Dec;55(6):E13. doi: 10.3171/2023.9.FOCUS23549.
Postcraniotomy pain (PCP) is a common finding after neurosurgical procedures, occurring in as many 87% of patients. The sphenopalatine ganglion (SPG) has a pivotal role in several headache syndromes, and its anesthetic block is currently used in different clinical conditions with benefit. The aim of this study was to evaluate the efficacy of an SPG block (SPGB) via a transnasal approach as adjunctive therapy in reducing pain scores during the postcraniotomy period.
In this single-center, double-blind, randomized controlled trial, patients undergoing elective surgery with a supratentorial craniotomy were randomly assigned to a scalp block, local anesthetic infiltration of the wound, and systemic analgesia during the first 48 postoperative hours (standard therapy), or to standard therapy as well as an SPGB (experimental therapy). According to the available evidence, assuming a 50% reduction in the incidence of the main outcome in patients with an SPGB (vs standard treatment), 82 patients were needed to achieve 80% statistical power in an intent-to-treat analysis. Pain intensity was recorded during the first 180 postoperative days at selective time points (5 times in the hospital, 3 times by telephone interview) with different pain rating systems (a visual analog scale [VAS], numeric rating scale [NRS], and pain assessment in advanced dementia [PAINAD] scale), together with demographic, clinical, and surgical variables and complications. Heart rate and blood pressure were recorded during surgery. Differences in all variables were evaluated using a paired t-test and confirmed through Wilcoxon matched-pairs signed-rank and Kruskal-Wallis tests.
No complications occurred among the 83 patients enrolled. Statistically significant differences were found in the mean VAS score at postoperative days 0 (p = 0.05), 2 (p = 0.03), and 3 (p = 0.03). The PAINAD scale score showed significant differences between groups at postoperative days 1 (p = 0.006), 2 (p = 0.001), 3 (p = 0.03), and 4 (p = 0.05). The proportion of patients reporting a VAS score ≥ 3 in the first day after surgery was lower in the SPGB group than in the standard treatment group (71.9% vs 89.5%), although this difference did not reach statistical significance. At postoperative day 180, 5 patients (2 in the control group, 3 in the treatment group) had developed chronic PCP (NRS score ≥ 3).
SPGB is a safe and effective procedure as an adjunctive treatment for PCP management in elective supratentorial craniotomy during the first 4 postoperative days compared with standard therapy. Further studies are needed to better define the clinical impact of SPGB use and its indications. Clinical trial registration no.: NCT05136625 (ClinicalTrials.gov).
开颅术后疼痛（PCP）是神经外科手术后常见的现象，多达 87%的患者会出现这种情况。蝶腭神经节（SPG）在几种头痛综合征中起着关键作用，其麻醉阻滞目前在不同的临床情况下都有一定的益处。本研究旨在评估经鼻 SPG 阻滞（SPGB）作为辅助治疗在降低开颅术后疼痛评分方面的疗效。
在这项单中心、双盲、随机对照试验中，接受择期幕上开颅手术的患者被随机分配到头皮阻滞、伤口局部麻醉浸润和术后 48 小时内的全身镇痛（标准治疗），或标准治疗加 SPGB（实验组）。根据现有证据，假设 SPGB 组（与标准治疗相比）主要结局发生率降低 50%，则需要 82 例患者进行意向治疗分析，以达到 80%的统计学效力。在选择性时间点（5 次在医院，3 次通过电话访谈）使用不同的疼痛评分系统（视觉模拟评分[VAS]、数字评分量表[NRS]和晚期痴呆疼痛评估[PAINAD]量表）记录术后第 180 天的疼痛强度，同时记录人口统计学、临床和手术变量以及并发症。术中记录心率和血压。使用配对 t 检验评估所有变量的差异，并通过 Wilcoxon 匹配对符号秩和检验和 Kruskal-Wallis 检验确认。
83 例患者中无并发症发生。术后第 0 天（p = 0.05）、第 2 天（p = 0.03）和第 3 天（p = 0.03）VAS 评分的平均值差异有统计学意义。术后第 1 天（p = 0.006）、第 2 天（p = 0.001）、第 3 天（p = 0.03）和第 4 天（p = 0.05）组间 PAINAD 量表评分差异有统计学意义。SPGB 组术后第 1 天 VAS 评分≥3 的患者比例低于标准治疗组（71.9% vs 89.5%），但差异无统计学意义。术后第 180 天，5 例患者（对照组 2 例，实验组 3 例）出现慢性 PCP（NRS 评分≥3）。
与标准治疗相比，SPGB 作为辅助治疗在开颅术后前 4 天管理 PCP 是一种安全有效的方法。需要进一步的研究来更好地确定 SPGB 使用的临床影响及其适应证。临床试验注册号：NCT05136625（ClinicalTrials.gov）。
