Cassandre Lambert, Gwenaelle Creff, Paul Coudert, Le Liboux Nicolas Bernard, Marin Chauvel, Benoit Godey
Department of Otorhinolaryngology-Head and Neck Surgery, Atlantic Brittany Hospital Centre, 20 bd Général Maurice Guillaudot, Vannes, 56000, France.
Department of Otorhinolaryngology-Head and Neck Surgery, Rennes University Hospital, 2 rue Henri Le Guilloux 35000, Rennes, France.
Eur Arch Otorhinolaryngol. 2025 Mar;282(3):1209-1216. doi: 10.1007/s00405-024-09014-z. Epub 2024 Oct 11.
To demonstrate the non-inferiority of perioperative comfort in patients undergoing otosclerosis surgery under local anesthesia versus general anesthesia and to compare audiometric results, quality of life and complications.
A prospective non-interventional study was performed. Patients undergoing otosclerosis surgery between January 2019 and March 2021 at the University Hospital of Rennes were included consecutively. Perioperative comfort of LA versus GA (at ward admission, surgery, recovery and 48 h following surgery) was measured on a visual analogue scale at 10 days postoperatively and quality of life by the Glasgow Benefit Inventory at 3 months. Complications and audiometric results were also assessed. To demonstrate the non-inferiority of LA versus GA with a margin of 1.5 points on the comfort VAS, a power of 80% and a first-order risk of 5, 100 patients were included and statistical analyses were performed in accordance with CONSORT2010 statement.
One hundred ears were analyzed, 46% operated under local anesthesia and 54% under general anesthesia. The two groups were similar in terms of demographic and pathological characteristics. Local anesthesia was non-inferior to general anesthesia in terms of comfort with a comfort VAS of 8.74 ± 1.55 and 9.08 ± 0.93 respectively (p < 0.0001). There were no significant differences in rates of complications, audiometric results and quality of life between local and general anesthesia.
Local anesthesia is non-inferior to general anesthesia in terms of perioperative patient comfort with similar audiometric results, postoperative quality of life and complication rates.
证明在耳硬化症手术中，局部麻醉与全身麻醉患者围手术期舒适度无差异，并比较听力测定结果、生活质量和并发症情况。
进行了一项前瞻性非干预性研究。连续纳入2019年1月至2021年3月在雷恩大学医院接受耳硬化症手术的患者。术后10天采用视觉模拟量表测量局部麻醉与全身麻醉（在病房入院、手术、恢复及术后48小时）的围手术期舒适度，术后3个月采用格拉斯哥获益量表评估生活质量。还评估了并发症和听力测定结果。为证明局部麻醉与全身麻醉在舒适度视觉模拟量表上相差1.5分的情况下非劣效性，检验效能为80%，一级风险为5%，纳入了100例患者，并根据CONSORT2010声明进行统计分析。
分析了100只耳朵，46%在局部麻醉下手术，54%在全身麻醉下手术。两组在人口统计学和病理特征方面相似。局部麻醉在舒适度方面不劣于全身麻醉，舒适度视觉模拟量表评分分别为8.74±1.55和9.08±0.93（p<0.0001）。局部麻醉和全身麻醉在并发症发生率、听力测定结果和生活质量方面无显著差异。
在围手术期患者舒适度方面，局部麻醉不劣于全身麻醉，听力测定结果、术后生活质量和并发症发生率相似。
