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Targeted Lidocaine Infusion for Pain Reduction in Office Hysteroscopy

ConditionsHysteroscopy / MethodsLidocaine InfusionPlacebo - Control
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorYAARA TABIB

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18

Referred for outpatient diagnostic or operative (see-and-treat) hysteroscopy

Able and willing to provide written informed consent

Disqualifiers

Pregnancy

Active pelvic inflammatory disease or cervicitis

Inability to consent

Anti-psychotic drugs usage

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lidocaine %2 ampoule

    Drug

    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.

  • Saline (0.9% NaCl)

    Other intervention

    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.

Treatment groups

208 Participants
are divided into 2 treatment groups
Group A: Control GroupPlacebo comparator 1 intervention
Group B: Lidocaine GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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.
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

YAARA TABIB

Lead sponsor

Hadassah Medical Organization

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: