Pain Control during Endometrial Sampling: A three-arm randomized controlled trial comparing lidocaine gel, spray and placebo
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Abstract
Objective: To compare the analgesic efficacy of 2% lidocaine gel, 10% lidocaine spray, and placebo during office-based endometrial sampling.
Materials and Methods: This three-arm randomized, placebo-controlled trial at Nakornping Hospital (Feb–Sep 2025) compared 2% lidocaine gel, 10% lidocaine spray, and placebo in women aged≥35 undergoing endometrial sampling. Pain was evaluated using a 10-cm Visual Analog Scale (VAS) across five procedural steps, both participants and operators’ satisfaction were assessed via a 5-point Likert scale. Statistical analyses were performed using ANOVA and multivariable linear regression.
Results: The study enrolled 115 women, randomized into three groups: 2% lidocaine gel (n=37), 10% lidocaine spray (n=39), and placebo (n=39). Baseline characteristics were comparable, except for prior vaginal delivery history. Median pain scores at procedural points P3–P5 (Endocell insertion, aspiration, and 10-minute recovery) were 12 (IQR 10), 13 (IQR 7), and 11 (IQR 8), respectively, with no significant differences between groups (p=0.611). Subgroup analysis showed that women aged 35–50 years (n=73) experienced significantly lower pain with 2% lidocaine gel compared to 10% spray (p=0.004). Participants and operators’ satisfaction were similar across groups. No adverse events were reported.
Conclusion: In this study, neither topical 2% lidocaine gel nor 10% lidocaine spray significantly reduced pain compared with placebo during endometrial sampling. A post-hoc subgroup analysis among women aged 35–50 years showed lower pain scores with lidocaine gel than with lidocaine spray; however, neither intervention differed significantly from placebo. This exploratory finding requires confirmation in an adequately powered study. Both agents were well tolerated, with no reported adverse events or complications.
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References
Novak E. Endometrial sampling. In: Berek JS, editor. Berek & Novak’s Gynecology. 14th ed. Philadelphia: Lippincott Williams & Wilkins; 2007. p. 465.
Vitale SG, Buzzaccarini G, Riemma G, Pacheco LA, Sardo ADS, Carugno J. Endometrial biopsy: indications, techniques and recommendations—an evidence-based guideline for clinical practice. J Gynecol Obstet Hum Reprod. 2023;52(6):102588.
Kulaksiz D, Erin R. Direct hysteroscopic endometrial sampling and Pipelle sampling in perimenopausal women. Minerva Obstet Gynecol. 2020;74(4):343–7.
Piotto M, Focchi G, Marques R, Teixeira A, Gonçalves W, Nicolau S. Assessment of preoperative endometrial histopathological sampling as a predictor of final surgical pathology in endometrial cancer. Rev Bras Ginecol Obstet. 2020;42(11):6428.
Aksoy H, Aksoy U, Ozyurt S, Acmaz G, Bayyigit MA, Yucel B. Effect of lidocaine spray in pain management during office-based endometrial sampling: a randomized placebo-controlled trial. J Obstet Gynaecol. 2016;36(2):246–50.
Kunavikitikul K, Suprasert P, Khunamornpong S, Settakorn J, Natprathan A. Accuracy of the Wallach Endocell endometrial cell sampler in diagnosing endometrial carcinoma and hyperplasia. J Obstet Gynaecol Res. 2011;37(5):483–6.
Karaca I, Yapca O, Adiyeke M, Toz E, Karaca S. Effect of cervical lidocaine gel for pain relief in Pipelle endometrial sampling. Eurasian J Med. 2016;48(3):189–91. doi:10.5152/eurasianjmed.2015.15084
Lambert B, Gonthier M, Dery JP, Lepage Y. Comparison of pain factors and randomized roles of Vabra and Wallach Endocell in endometrial evaluation. Gynecol Obstet Invest. 1998;45(4):258–61.
Charoenkwan K, Nanthasupha C. Methods of pain control during endometrial biopsy: a systematic review and meta-analysis of randomized controlled trials. J Obstet Gynaecol Res. 2020;46(1):9–30.
Ahmed A, Ahmed S, Abd A, Mustafa K, Mohammed A, Mahmoud R, et al. Medications for pain relief in outpatient endometrial sampling or biopsy: a systematic review and network meta-analysis. Fertil Steril. 2019;112(1):140–8.
Somchit W, Lertkhachonsuk A, Vallipakorn S. Naproxen for pain relief during endometrial biopsy: a randomized controlled trial. J Med Assoc Thai. 2015;98(7):631–5.
Likkasitipan N, Wariyasirivaj B. Effect of lidocaine gel for pain relief during endometrial sampling: a double-blinded randomized controlled trial. Thai J Obstet Gynaecol. 2021;29(4):273–80.
Piyawetchakarn R, Charoenkwan K. Effects of lidocaine spray for reducing pain during endometrial aspiration biopsy: a randomized controlled trial. J Obstet Gynaecol Res. 2019;45(5):987–93.
Kornsuwan P, Wiriyasirivaj B. Lidocaine spray for pain control during office-based endometrial biopsy: a randomized placebo-controlled trial. Thai J Obstet Gynaecol. 2018;26(3):262–9.
Sripha M, Charakorn C, Lekskul N, Lertkhachonsuk A. Analgesic effect of lidocaine spray during endometrial biopsy: a randomized controlled trial. Thai J Obstet Gynaecol. 2018;26(2):190–7.
Abbas A, Ellah N, Hosmy M, Abdellah S, Ali M. Self-administered vaginal 2% lidocaine in-situ gel for pain relief during copper intrauterine device insertion in women with previous cesarean delivery only: a double-blind randomized placebo-controlled trial. Eur J Contracept Reprod Health Care. 2021;26(2):132–8.
Tueman K. Lidocaine gel combined with ibuprofen versus ibuprofen alone for pain relief during an endometrial biopsy: a randomized controlled trial. Thai J Obstet Gynaecol. 2026;34(1):30-41.
González-Roldán AM, Terrasa JL, Sitges C, van der Meulen M, Anton F, Montoya P. Age-related changes in pain perception are associated with altered functional connectivity during resting state. Front Aging Neurosci. 2020;12:116.
