LIM-62, Instituto do Cancer do Estado de São Paulo Pain Center, School of Medicine, University of São Paulo, São Paulo, SP, Brazil.
Instituto de Ensino e Pesquisa da Rede D'Or-IDOR, São Paulo, SP, Brazil.
Pain. 2021 Mar 1;162(3):919-929. doi: 10.1097/j.pain.0000000000002070.
Surgical procedures are necessary in up to 50% of trigeminal neuralgia patients. Although radiofrequency (RF) is more widely used, it is associated with high intraprocedural costs and long technical learning time. Other simpler procedures such as balloon compression (BC) require a lower training period and have significant lower costs. We evaluated the effects of BC and RF in pain control in primary trigeminal neuralgia in a randomized, double-blinded, head-to-head trial. Individuals were randomly allocated in 1 of 2 groups: BC and RF. Throughout pain, psychological and quality of life measurements were performed at baseline and after surgery. The main outcome was the worst pain in the last 24 hours (0-10) at 6 months postoperatively. After the inclusion of half of the estimated sample, a preplanned interim analysis was performed when 33 patients (62.1 ± 9.4 y.) completed the study. Pain intensity (confidence interval [CI] 95% 0.6 to 3.8, and -0.6 to 2.2, for BC and RF) did not significantly differ. Complications, interference of pain in daily life (CI 95% -0.1 to 2.3 and -0.4 to 2.3, for BC and RF), neuropathic pain symptoms (CI 95% 1.7 to 3.6 and 3.0 to 5.7, for BC and RF), mood (CI 95% 4.8 to 11.5 and 5.5 to 15.1, BC and RF, respectively), medication use, and quality of life (CI 95% 80.4 to 93.1 and 83.9 to 94.2, for BC and RF) were also not different. Radiofrequency presented more paresthetic symptoms than BC at 30 days after intervention. Based on these results, the study was halted due to futility because BC was not superior to RF.
在高达 50%的三叉神经痛患者中需要进行手术。尽管射频（RF）的应用更为广泛，但它与术中成本高和技术学习时间长有关。其他更简单的手术，如球囊压迫（BC），需要的培训时间较短，且成本显著较低。我们在一项随机、双盲、头对头试验中评估了 BC 和 RF 在原发性三叉神经痛疼痛控制中的效果。将个体随机分配到 2 组中的 1 组：BC 和 RF。在基线和手术后进行疼痛、心理和生活质量测量。主要结局是术后 6 个月时 24 小时内的最剧烈疼痛（0-10）。在纳入预计样本的一半后，当 33 名患者（62.1±9.4 岁）完成研究时，进行了计划中的中期分析。疼痛强度（置信区间 [CI] 95%：0.6 至 3.8，和 -0.6 至 2.2，BC 和 RF）无显著差异。并发症、疼痛对日常生活的干扰（CI 95%：-0.1 至 2.3 和 -0.4 至 2.3，BC 和 RF）、神经病理性疼痛症状（CI 95%：1.7 至 3.6 和 3.0 至 5.7，BC 和 RF）、情绪（CI 95%：4.8 至 11.5 和 5.5 至 15.1，BC 和 RF）、药物使用和生活质量（CI 95%：80.4 至 93.1 和 83.9 至 94.2，BC 和 RF）也无差异。在干预后 30 天，RF 比 BC 出现更多的感觉异常症状。基于这些结果，由于无效，该研究因无效而停止，因为 BC 并不优于 RF。
