Hysteroscopy / Methods, Lidocaine Infusion, Placebo - Control
Conditions
Brief summary
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.
Interventions
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.
OTHERSaline (0.9% NaCl)
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.
Sponsors
YAARA TABIB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 * Referred for outpatient diagnostic or operative (see-and-treat) hysteroscopy * Able and willing to provide written informed consent
Exclusion criteria
* Pregnancy * Active pelvic inflammatory disease or cervicitis * Inability to consent * Anti-psychotic drugs usage * Previews cervical surgery (i.e., conization). * Any contraindication for office hysteroscopy- cervical malignancy, profuse uterine bleeding, invisible external os, recent uterine perforation. * Known allergy or hypersensitivity to Lidocaine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain During Hysteroscopy Procedure Assessed by Visual Analog Scale (VAS) | Immediately during the hysteroscopy procedure | 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. |
| Number of Participants with Successful Access to the Uterine Cavity | During the hysteroscopy procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completed procedure | During the hysteroscopy procedure | Successful performance of the intended hysteroscopic procedure. Subgroup analyses will be performed by age group, parity, cesarean delivery history, and menopausal status. |
| Visual Analog Scale (VAS) Pain Score 5 Minutes After the Procedure | 5 minutes after completion of the hysteroscopy 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. |
| Adverse effect | During and up to 10 minutes after the procedure | Recording any vasovagal symptoms observed or reported, including nausea, bradycardia, or hypotension. |
| Patient satisfaction | Immediately after the procedure | 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. |
| Change in Visual Analog Scale (VAS) Pain Score from Baseline to During the Procedure | Changes of VAS score of pain from baseline (before procedure) and at 5 minutes of during 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. |
Outcome results
None listed