Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.
Department of Histology, Kasr Alainy, Faculty of Medicine, Cairo University, Cairo, Egypt.
Climacteric. 2020 Aug;23(4):397-403. doi: 10.1080/13697137.2020.1742685. Epub 2020 Apr 17.
This study aimed to compare efficacy and safety of lidocaine versus tramadol versus placebo in reducing the pain of diagnostic outpatient hysteroscopy (OH) in postmenopausal women. This randomized double-blinded study included 156 menopausal women who received intrauterine lidocaine infusion or oral tramadol (50 mg) or placebo before diagnostic OH (52 women/group). Primary outcome was pain severity during the procedure using a 10-cm visual analog scale. Secondary outcomes were pain scores 10 and 30 min post procedure, satisfaction level, and ease of cervical entry. Lidocaine had lower pain scores compared to placebo during and 10 min after the procedure ( < 0.001). Tramadol had lower pain scores than placebo during the procedure ( = 0.04), 10 min after the procedure ( = 0.03), and 30 min after the procedure ( = 0.04). Both lidocaine and tramadol resulted in an easier procedure than placebo ( < 0.001 and = 0.04, respectively). Lidocaine had an easier cervical entry compared to tramadol ( = 0.004). Satisfaction scores in the lidocaine and tramadol groups were significantly higher than in the placebo group ( < 0.001). Lidocaine and tramadol were effective in reducing postmenopausal women-reported pain during and after diagnostic OH. However, lidocaine was better than tramadol in facilitating hysteroscope passage through the cervical canal and the reduction in pain levels with lidocaine was clinically relevant. NCT03701984.
本研究旨在比较利多卡因、曲马多和安慰剂在减轻绝经后妇女门诊宫腔镜检查（OH）疼痛中的疗效和安全性。这项随机、双盲研究纳入了 156 名绝经后妇女，她们在诊断性 OH 前接受了宫内利多卡因输注或口服曲马多（50mg）或安慰剂（每组 52 名妇女）。主要结局是使用 10cm 视觉模拟评分（VAS）评估手术过程中的疼痛严重程度。次要结局是术后 10min 和 30min 的疼痛评分、满意度和宫颈进入的难易程度。与安慰剂相比，利多卡因在手术过程中和术后 10min 的疼痛评分较低（<0.001）。曲马多在手术过程中（=0.04）、术后 10min（=0.03）和术后 30min（=0.04）的疼痛评分均低于安慰剂。与安慰剂相比，利多卡因和曲马多都使手术过程更容易（<0.001 和=0.04）。与曲马多相比，利多卡因的宫颈进入更容易（=0.004）。利多卡因和曲马多组的满意度评分明显高于安慰剂组（<0.001）。利多卡因和曲马多均可有效减轻绝经后妇女诊断性 OH 期间和之后的疼痛。然而，利多卡因在促进宫腔镜通过宫颈管和降低疼痛水平方面优于曲马多，且利多卡因的降痛效果具有临床意义。NCT03701984。
