Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, the Netherlands; Department of Obstetrics and Gynaecology, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, the Netherlands.
Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, the Netherlands.
Eur J Obstet Gynecol Reprod Biol. 2020 Nov;254:206-211. doi: 10.1016/j.ejogrb.2020.09.011. Epub 2020 Sep 9.
To evaluate the effect of intrauterine fundal anaesthesia during outpatient endometrial ablation.
A randomised, double-blinded non-inferiority trial was performed in one hospital and one independent treatment center in the Netherlands. A total of 96 women who were planned for a NovaSure® endometrial ablation under local anaesthesia between December 2015 and February 2018 were included in this trial. These women were randomised to paracervical anaesthesia combined with hysteroscopic fundal infiltration with anaesthestics or paracervical anaesthesia combined with hysteroscopic fundal infiltration with saline. The primary outcome was pain during ablation. To study non-inferiority of paracervical anaesthesia without fundal anaesthesia, we assessed the co-primary endpoints Faces Pain Score and Numeric Rating Score. Secondary outcomes included pain scores at other moments during and after the procedure, postoperative use of analgesics, satisfaction, side-effects and complications. The primary outcomes were tested with a non-inferiority margin (2.0 points on changes in pain), and the secondary outcomes were compared using conventional statistical methods.
Paracervical anaesthesia without fundal anaesthesia did not establish non-inferiority to the combination of paracervical anaesthesia and fundal infiltration with anaesthetics when both primary outcome variables of pain were taken into account (Numeric Rating Scale 5.0 versus 3.9 (mean difference 1.2 (95% CI 0.1-2.2)) and Faces Pain Score 5.4 versus 4.8 (mean difference 0.6 (95% CI -0.3-1.5))). Secondary pain scores measured during the procedure were higher or similar in women receiving fundal infiltration with saline as compared to women who received fundal infiltration with anaesthetics. After the procedure, there were no differences in reported pain scores, satisfaction, and side-effects. In the group who received fundal infiltration with saline, more women were admitted to the hospital because of severe pain (3 versus 0 women) and endometritis (1 versus 0 women).
This study did not confirm non-inferiority of paracervical anaesthesia without fundal anaesthesia to the combination of paracervical anaesthesia with fundal anaesthesia in the reduction of pain during endometrial ablation and therefore provides no reason to leave out fundal anaesthesia. We recommend to use fundal anaesthesia combined with paracervical anaesthesia to reduce pain during endometrial ablation in the office.
评估门诊子宫内膜消融术中子宫底部麻醉的效果。
这是一项在荷兰的一家医院和一家独立治疗中心进行的随机、双盲非劣效性试验。2015 年 12 月至 2018 年 2 月期间，共有 96 名计划在局部麻醉下接受 NovaSure®子宫内膜消融术的女性参与了这项试验。这些女性被随机分配到宫颈旁麻醉联合宫腔镜子宫底部浸润麻醉或宫颈旁麻醉联合宫腔镜子宫底部浸润生理盐水。主要结局是消融过程中的疼痛。为了研究不进行子宫底部麻醉的宫颈旁麻醉的非劣效性，我们评估了共同主要结局的面部疼痛评分和数字评分。次要结局包括手术过程中和手术后其他时间的疼痛评分、术后使用镇痛药、满意度、副作用和并发症。主要结局采用非劣效性边界（疼痛变化 2.0 分）进行检验，次要结局采用常规统计学方法进行比较。
当考虑到疼痛的两个主要结局变量时，不进行子宫底部麻醉的宫颈旁麻醉与宫颈旁麻醉联合子宫底部浸润麻醉相比，并未显示出非劣效性（数字评分 5.0 与 3.9（平均差值 1.2（95%CI 0.1-2.2））和面部疼痛评分 5.4 与 4.8（平均差值 0.6（95%CI -0.3-1.5）））。接受生理盐水子宫底部浸润的女性在手术过程中测量的次要疼痛评分较高或相似，而接受麻醉剂子宫底部浸润的女性则较低。手术后，报告的疼痛评分、满意度和副作用没有差异。在接受生理盐水子宫底部浸润的女性中，更多的女性因严重疼痛（3 名女性与 0 名女性）和子宫内膜炎（1 名女性与 0 名女性）而住院。
这项研究并未证实不进行子宫底部麻醉的宫颈旁麻醉在减轻子宫内膜消融过程中的疼痛方面与宫颈旁麻醉联合子宫底部麻醉具有非劣效性，因此没有理由不进行子宫底部麻醉。我们建议在办公室进行子宫内膜消融术时使用子宫底部麻醉联合宫颈旁麻醉以减轻疼痛。
