HYSPAIN CLINICAL TRIAL Testing the Efficacy of Paracervical Anesthesia for Pain Control During Office Hysteroscopy: A Randomized, Single-Center, Double-Blind, Placebo-Controlled Clinical Trial

<b>Introduction:</b> Hysteroscopy is a key gynecological procedure for diagnosing and treating endometrial conditions. While hysteroscopy is often performed in office settings without sedation, patients frequently report significant pain during the procedure. This study aims to evaluate the efficacy of paracervical anesthesia with mepivacaine compared to placebo in managing pain during office hysteroscopy. <b>Methods:</b> This randomized, single-center, double-blind, placebo-controlled trial was conducted at Puerta de Hierro University Hospital (Madrid, Spain) from June 2021 to June 2022. A total of 108 women were randomized to receive either mepivacaine 2% or a saline placebo prior to hysteroscopy. Pain was assessed using a visual analog scale (VAS) at various stages of the procedure. <b>Results:</b> The results showed no significant differences in pain levels between the mepivacaine and placebo groups during the procedure. Both groups exhibited similar rates of complications and procedural difficulties. Factors influencing perceived pain included a history of vaginal delivery and the type of instruments used, but anesthesia did not demonstrate a significant impact on pain reduction in any subgroup. <b>Discussion</b>: Our findings indicate that paracervical anesthesia with mepivacaine does not significantly reduce pain during office hysteroscopy, consistent with previous studies. The variability in pain experiences suggests that individual factors, such as pain thresholds and anxiety, may play a significant role. A more personalized approach to pain management, combining pharmacological and non-pharmacological strategies, may be necessary to enhance patient comfort. Future research should involve larger multicenter trials to further explore these findings.

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Publication Details

Journal
Journal of Clinical Medicine
Published
2024-12-23
DOI
https://doi.org/10.3390/jcm13247856
Citations
3
Primary Topic
Gynecological conditions and treatments
Type
article
Field-Weighted Citation Impact
1.75

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article

HYSPAIN CLINICAL TRIAL Testing the Efficacy of Paracervical Anesthesia for Pain Control During Office Hysteroscopy: A Randomized, Single-Center, Double-Blind, Placebo-Controlled Clinical Trial

Laura Calles Sastre, Tirso Pérez‐Medina, Augusto Pereira, Salvatore Giovanni Vitale et al.
3 citations
Journal of Clinical Medicine
Gynecological conditions and treatments
1.75
article

HYSPAIN CLINICAL TRIAL Testing the Efficacy of Paracervical Anesthesia for Pain Control During Office Hysteroscopy: A Randomized, Single-Center, Double-Blind, Placebo-Controlled Clinical Trial

Laura Calles Sastre, Tirso Pérez‐Medina, Augusto Pereira, Salvatore Giovanni Vitale, María Adrién-Lara, Mar Ríos
article en
3 citations

Abstract

<b>Introduction:</b> Hysteroscopy is a key gynecological procedure for diagnosing and treating endometrial conditions. While hysteroscopy is often performed in office settings without sedation, patients frequently report significant pain during the procedure. This study aims to evaluate the efficacy of paracervical anesthesia with mepivacaine compared to placebo in managing pain during office hysteroscopy. <b>Methods:</b> This randomized, single-center, double-blind, placebo-controlled trial was conducted at Puerta de Hierro University Hospital (Madrid, Spain) from June 2021 to June 2022. A total of 108 women were randomized to receive either mepivacaine 2% or a saline placebo prior to hysteroscopy. Pain was assessed using a visual analog scale (VAS) at various stages of the procedure. <b>Results:</b> The results showed no significant differences in pain levels between the mepivacaine and placebo groups during the procedure. Both groups exhibited similar rates of complications and procedural difficulties. Factors influencing perceived pain included a history of vaginal delivery and the type of instruments used, but anesthesia did not demonstrate a significant impact on pain reduction in any subgroup. <b>Discussion</b>: Our findings indicate that paracervical anesthesia with mepivacaine does not significantly reduce pain during office hysteroscopy, consistent with previous studies. The variability in pain experiences suggests that individual factors, such as pain thresholds and anxiety, may play a significant role. A more personalized approach to pain management, combining pharmacological and non-pharmacological strategies, may be necessary to enhance patient comfort. Future research should involve larger multicenter trials to further explore these findings.

Journal of Clinical MedicineVol. 13(24)
University of Cagliari (IT), Hospital Universitario Puerta de Hierro Majadahonda (ES)
Agencia Española de Medicamentos y Productos Sanitarios
Good health and well-being
Openalex Percentile: Top 14%
Gynecological conditions and treatments
1.75
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