Academic Vascular Surgery, Hull-York Medical School, Hull Royal Infirmary, Hull, UK.
Academic Vascular Surgery, Hull-York Medical School, Hull Royal Infirmary, Hull, UK.
Eur J Vasc Endovasc Surg. 2018 Nov;56(5):699-708. doi: 10.1016/j.ejvs.2018.05.017. Epub 2018 Jun 29.
OBJECTIVE/BACKGROUND: Endovenous thermal ablation (EVTA) is the recommended first line intervention for superficial venous incompetence (SVI). While the infiltration of perivenous tumescent local anaesthesia (TLA) is key to procedural success, it is paradoxically the predominant source of patient reported discomfort. This randomised controlled trial investigates the potential to reduce peri-procedural pain and improve patient reported outcome measures (PROMs), including quality of life (QoL) using TLA buffered to physiological pH.
Patients undergoing great saphenous vein EVTA with concomitant phlebectomies were randomised to either standard (ST) or buffered (BT) TLA. Follow up assessments were performed at weeks 1, 6, and 12. The primary outcome was patient reported peri-procedural pain on a 100 mm visual analogue scale (VAS). Secondary outcomes were one week post-procedural pain VAS and analgesia use, QoL (disease specific: Aberdeen Varicose Vein Questionnaire [AVVQ]; generic: Short Form-36 [SF-36] and EuroQol 5 Dimensions Questionnaire [EQ-5D]), patient satisfaction VAS, technical success on duplex ultrasound (DUS) examination, and complications.
Ninety-seven patients were randomised: 50 to ST and 47 to BT. The groups had comparable baseline demographics, Clinical Etiologic Anatomic Pathological, Venous Clinical Severity Score, QoL, and DUS parameters. Equally, intra-procedural parameters (volume of TLA, length of ablation, and linear energy delivered) were also comparable. Peri-procedural pain scores were significantly lower in the BT group with a mean ± SD score of 2.86 ± 3.57 versus 4.44 ± 2.94 (p = .001). Pain scores and analgesia use over the subsequent week were equivalent. SF-36 Bodily Pain domain scores were significantly better in the BT group at week 1 (77 vs. 62; p = .008). AVVQ, SF-36, and EQ-5D scores were otherwise similar between the groups throughout follow up, significantly improving over baseline. Technical success was high in both groups, with no major complications and few minor complications.
Buffered TLA offers a significantly lower peri-procedural pain experience for patients undergoing EVTA and should replace current tumescent formulae.
目的/背景：静脉内热消融（EVTA）是治疗浅静脉功能不全（SVI）的首选一线干预措施。虽然静脉周围肿胀局部麻醉（TLA）的渗透是手术成功的关键，但它恰恰是患者报告不适的主要来源。这项随机对照试验研究了使用生理 pH 值缓冲的 TLA 减轻围手术期疼痛和改善患者报告的结果测量（PROMs），包括生活质量（QoL）的潜力。
接受大隐静脉 EVTA 联合静脉切除术的患者被随机分为标准（ST）或缓冲（BT）TLA 组。在第 1、6 和 12 周进行随访评估。主要结局是患者报告的 100mm 视觉模拟量表（VAS）的围手术期疼痛。次要结局是术后一周的 VAS 疼痛和镇痛使用、QoL（特定疾病：阿伯丁静脉曲张问卷 [AVVQ]；通用：36 项简短健康调查 [SF-36] 和欧洲五维健康量表 [EQ-5D]）、患者满意度 VAS、双功超声（DUS）检查的技术成功率和并发症。
97 名患者被随机分配：50 名至 ST 组，47 名至 BT 组。两组基线人口统计学、临床病因解剖病理、静脉临床严重程度评分、QoL 和 DUS 参数相似。同样，术中参数（TLA 体积、消融长度和线性能量输送）也相似。BT 组的围手术期疼痛评分明显较低，平均±标准差评分为 2.86±3.57 与 4.44±2.94（p=0.001）。随后一周的疼痛评分和镇痛使用相当。BT 组在第 1 周的 SF-36 躯体疼痛域评分明显更好（77 与 62；p=0.008）。AVVQ、SF-36 和 EQ-5D 评分在整个随访过程中在两组之间相似，均较基线显著改善。两组的技术成功率均较高，无重大并发症，少数轻微并发症。
接受 EVTA 的患者使用缓冲 TLA 可显著降低围手术期疼痛体验，应替代当前的肿胀配方。
Zotero 插件