Pain management during diagnostic office hysteroscopy in postmenopausal women: a randomized study

Abstract

Objective: 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.

Materials and methods: 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.

Results: Lidocaine had lower pain scores compared to placebo during and 10 min after the procedure (p < 0.001). Tramadol had lower pain scores than placebo during the procedure (p = 0.04), 10 min after the procedure (p = 0.03), and 30 min after the procedure (p = 0.04). Both lidocaine and tramadol resulted in an easier procedure than placebo (p < 0.001 and p = 0.04, respectively). Lidocaine had an easier cervical entry compared to tramadol (p = 0.004). Satisfaction scores in the lidocaine and tramadol groups were significantly higher than in the placebo group (p < 0.001).

Conclusions: 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.

Trial registration number: NCT03701984

摘要

目的：比较利多卡因、曲马多和安慰剂对绝经后妇女诊断性门诊宫腔镜检查时降低疼痛的有效性和安全性。

材料与方法：本研究采用随机双盲法, 对156例绝经妇女在诊断性门诊宫腔镜时给予宫内注射利多卡因或曲马多口服（50mg）或安慰剂治疗（52例/组）。主要结果是在治疗中使用10-cm视觉模拟量表评估疼痛严重程度。次要结果是术后10分钟和30分钟的疼痛评分、满意度和宫颈进入的容易程度。

结果：利多卡因组术中及术后10分钟疼痛评分均低于安慰剂组（p<0.001）。曲马多的疼痛评分在手术期间（p=0.04）、手术后10分钟（p=0.03）和手术后30分钟（p=0.04）低于安慰剂。利多卡因和曲马多都比安慰剂容易操作（分别p<0.001和p=0.04）。利多卡因比曲马多更容易进入宫颈（p=0.004）。利多卡因组和曲马多组的满意度得分显著高于安慰剂组（p<0.001）。

结论：利多卡因和曲马多能有效地减轻绝经后妇女在诊断性门诊宫腔镜期间和治疗后的疼痛。然而, 利多卡因在促进宫腔镜通过宫颈管方面优于曲马多, 利多卡因降低疼痛水平具有临床意义。

临床试验注册号：NCT 03701984

Keywords:

• Intrauterine lidocaine
• hysteroscopy
• tramadol
• postmenopausal women

Acknowledgements

The authors thank Mrs Yasmin Negm (Teacher at Om El Momineen Primary School, Helwan, Egypt) for her invaluable efforts in recording and organizing study data and computer works.

Potential conflict of interest

No potential conflict of interest was reported by the authors.

Source of funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.