Freisleben Moritz, Petzel Anja, Jülicher Anne, Jonas Anna, Betzler Janina, Choly Natalia, Pashayeva Esmira, Porthun Jan, Welcker Thomas, Schneider Viola, Kaufmann Andreas M, Schneider Achim
Praxis Dr. Katrin Schäfer, Hennigsdorf, Germany.
Institut für Zytologie und Dysplasie, Berlin, Germany.
Geburtshilfe Frauenheilkd. 2023 Sep 14;83(10):1263-1273. doi: 10.1055/a-2150-0835. eCollection 2023 Oct.
In Germany, treatment of HSIL or AIS of the uterine cervix by loop excision is performed almost exclusively under general anaesthesia (GA). International studies and guidelines show high acceptance of local anaesthesia (LA) due to hermeneutic, medical, and economic factors. We performed an observational comparative study aiming to prove advantages of local anaesthesia within the German health system.
In a prospective observational study, patients diagnosed with HSIL or AIS of the uterine cervix were treated at the Institute for Cytology and Dysplasia, Berlin, by loop excision in 2021. We started with a feasibility study : 303 patients diagnosed with HSIL/AIS of the uterine cervix and her colposcopist answered an electronic questionnaire with respect to loop excision under LA. Since we found a high acceptance for LA in patients and colposcopists, we initiated a comparative study LA vs. GA: 322 patients underwent loop excision and selected their mode of anaesthesia: n = 206 LA vs. n = 116 GA. 114 patients of the feasibility study had to undergo loop excision and became part of the comparative study (n = 79 for the LA group, n = 35 for the GA group). All patients received a standardised questionnaire to document their pain score within 24 h after treatment on a visual analogue scale, i.e. VAS, between 0 and 100. 178 patients of the LA group and 80 patients of the GA group completed and returned the questionnaire and form the cohort for our comparison of LA vs. GA. With 191 of these 258 patients, i.e. 74%, a telephone survey was performed to ask for patient satisfaction and the rates of recurrence after a mean interval of 1 year post surgery. We postulate that there will be no clinically relevant significant difference in satisfaction and postoperative pain between patients in the LA group and the GA group.
In the feasibility study , 90% (272 of 303) of patients diagnosed with HSIL or AIS were considered eligible for LA by their colposcopists. 75% (227 of 303) of patients were open to loop excision under LA. In the comparative study , 63 of 206 women of the LA group were interviewed preoperatively: 89% would accept a pain score above 20 during the procedure, 33% a pain score above 50 and 11% of max. 20. Postoperatively, the median VAS pain score for loop excision under local anaesthesia was 13.1 in 178 patients, and pain during injection of local anaesthesia was 20.9 (p < 0.001). The VAS pain score 20 minutes post surgery did not differ significantly between 178 patients after local anaesthesia versus 80 patients after general anaesthesia (p = 0.09). The surgeons estimated the patient's pain significantly less than the patients themselves with an underestimate of -14.63 points on the VAS (p < 0.001). Within 7 days following loop excision under LA, 95.5% of 178 patients would choose local anaesthesia as their preferred method for a potential repeat loop excision, 8.8% of which would like additional painkillers, and 4.5% would choose general anaesthesia.In a telephone follow-up survey of 133 women from the LA group after a mean of 12 months post surgery, 97% were "satisfied" or "very satisfied" with the treatment carried out. For patient satisfaction and postoperative pain, no clinically relevant significant difference was seen between the LA and the GA group.The rate of secondary bleeding (6.7% vs. 8.1%, p = 0.72), recurrence of HSIL/AIS (3.6% vs. 5.2%, p = 0.62), and the distribution of the histopathological R status (R0 89.5% vs. 81.1%, p = 0.73; R1 5.3% vs.12.2%, p = 0.57, Rx 4.1% vs. 5.4%, p = 0.65) showed no significant difference when comparing the LA group versus the GA group.
Following loop excision under local anaesthesia, more than 95% of patients would choose this method again for repeat surgery. One year post surgery, 97% of the patients were "satisfied" or "very satisfied" with the treatment under local anaesthesia. Offering local anaesthesia for loop excision to patients should be mandatory and included in current guidelines.
在德国，子宫颈高级别鳞状上皮内病变（HSIL）或原位腺癌（AIS）几乎仅在全身麻醉（GA）下进行环形切除术。国际研究和指南表明，由于解释学、医学和经济因素，局部麻醉（LA）的接受度很高。我们进行了一项观察性比较研究，旨在证明在德国医疗体系中局部麻醉的优势。
在一项前瞻性观察研究中，2021年在柏林细胞学与发育异常研究所对诊断为子宫颈HSIL或AIS的患者进行环形切除术。我们首先进行了一项可行性研究：303例诊断为子宫颈HSIL/AIS的患者及其阴道镜检查医师回答了一份关于局部麻醉下环形切除术的电子问卷。由于我们发现患者和阴道镜检查医师对局部麻醉接受度很高，我们启动了一项局部麻醉与全身麻醉的比较研究：322例患者接受了环形切除术并选择了麻醉方式：n = 206例局部麻醉 vs. n = 116例全身麻醉。可行性研究中的114例患者必须接受环形切除术并成为比较研究的一部分（局部麻醉组n = 79例，全身麻醉组n = 35例）。所有患者均收到一份标准化问卷，以使用视觉模拟量表（即VAS，范围为0至100）记录其治疗后24小时内的疼痛评分。局部麻醉组的178例患者和全身麻醉组的80例患者完成并返回了问卷，构成了我们局部麻醉与全身麻醉比较的队列。在这258例患者中的191例（即74%）中，进行了电话调查，询问患者满意度以及术后平均1年的复发率。我们假设局部麻醉组和全身麻醉组患者在满意度和术后疼痛方面不会存在临床相关的显著差异。
在可行性研究中，阴道镜检查医师认为90%（303例中的272例）诊断为HSIL或AIS的患者适合局部麻醉。75%（303例中的227例）的患者愿意接受局部麻醉下的环形切除术。在比较研究中，局部麻醉组的206名女性中有63名在术前接受了访谈：89%的患者愿意接受术中疼痛评分高于20分，33%的患者愿意接受高于
50分的疼痛评分，11%的患者愿意接受最高20分的疼痛评分。术后，178例患者局部麻醉下环形切除术的VAS疼痛评分中位数为13.1分，局部麻醉注射时疼痛评分为20.9分（p < 0.001）。局部麻醉后178例患者与全身麻醉后80例患者术后20分钟的VAS疼痛评分无显著差异（p = 0.09）。外科医生对患者疼痛的估计明显低于患者自身，VAS低估了 -14.63分（p < 0.001）。在局部麻醉下环形切除术后7天内，178例患者中有95.5%会选择局部麻醉作为潜在重复环形切除术的首选方法，其中8.8%希望使用额外的止痛药，4.5%会选择全身麻醉。在对局部麻醉组133名女性进行术后平均12个月的电话随访调查中，97%的患者对所进行的治疗“满意”或“非常满意”。局部麻醉组和全身麻醉组在患者满意度和术后疼痛方面未观察到临床相关的显著差异。继发性出血率（6.7% vs. 8.1%，p = 0.72）、HSIL/AIS复发率（3.6% vs. 5.2%，p = 0.62）以及组织病理学R状态分布（R0 89.5% vs. 81.1%，p = 0.73；R1 5.3% vs.12.2%，p = 0.57，Rx 4.1% vs. 5.4%，p = 0.65）在比较局部麻醉组与全身麻醉组时无显著差异。
局部麻醉下环形切除术后，超过95%的患者会再次选择这种方法进行重复手术。术后1年，97%的患者对局部麻醉下的治疗“满意”或“非常满意”。应为患者提供局部麻醉下的环形切除术，并将其纳入现行指南。
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