The goal of this study is to find out whether a small amount of lidocaine (a common local anesthetic) can reduce pain during office hysteroscopy - a procedure used to look inside the uterus. The study will compare lidocaine to saline (salt water) to see which one helps more with pain relief. Participants will: 1. Receive either lidocaine or saline gently applied inside the cervix right before the procedure 2. Undergo the hysteroscopy as planned 3. Be asked to rate their pain and satisfaction after the procedure Lidocaine is commonly and safely used in dental and gynecological procedures. Participation is voluntary, and the procedure itself will not change.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
208
A 5 mL dose of 2% lidocaine solution will be infused slowly through the internal os using the hysteroscope before the start of uterine cavity distension.
A 5 mL dose of sterile normal saline will be infused slowly through the internal os using the same technique as in the intervention arm, immediately before cavity distension.
Pain During Hysteroscopy Procedure Assessed by Visual Analog Scale (VAS)
Pain experienced during the procedure, evaluated using a Visual Analog Scale (VAS). The VAS score ranging between 0 (no pain) to 10 (worst imaginable pain). Subgroup analyses will be performed by age group, parity, cesarean delivery history, and menopausal status.
Time frame: Immediately during the hysteroscopy procedure
Number of Participants with Successful Access to the Uterine Cavity
The number of participants for whom hysteroscopy successfully reached the uterine cavity, without the need to stop or repeat the procedure. This binary outcome (Yes/No) will be assessed by the performing physician during the procedure. Subgroup analyses will be performed by age group, parity, cesarean delivery history, and menopausal status.
Time frame: During the hysteroscopy procedure
Visual Analog Scale (VAS) Pain Score 5 Minutes After the Procedure
Pain intensity assessed using a Visual Analog Scale (VAS) exactly 5 minutes following the end of the hysteroscopy. The VAS score ranging between 0 (no pain) to 10 (worst imaginable pain). Subgroup analyses will be performed by age group, parity, cesarean delivery history, and menopausal status.
Time frame: 5 minutes after completion of the hysteroscopy procedure
Change in Visual Analog Scale (VAS) Pain Score from Baseline to During the Procedure
The outcome will measure the change in pain score using the Visual Analog Scale (VAS) from baseline (immediately before the hysteroscopy) to during the procedure. The VAS score ranging between 0 (no pain) to 10 (worst imaginable pain). Subgroup analyses will be performed by age group, parity, cesarean delivery history, and menopausal status.
Time frame: Changes of VAS score of pain from baseline (before procedure) and at 5 minutes of during procedure.
Completed procedure
Successful performance of the intended hysteroscopic procedure. Subgroup analyses will be performed by age group, parity, cesarean delivery history, and menopausal status.
Time frame: During the hysteroscopy procedure
Patient satisfaction
Patient-reported satisfaction with the procedure using a validated 5-point Likert scale. Subgroup analyses will be performed by age group, parity, cesarean delivery history, and menopausal status.
Time frame: Immediately after the procedure
Adverse effect
Recording any vasovagal symptoms observed or reported, including nausea, bradycardia, or hypotension.
Time frame: During and up to 10 minutes after the procedure
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