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.

Introduction

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.

Methods

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.

Results

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. Discussion: 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.