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NCT Number: NCT07318285

Targeted Lidocaine Infusion for Pain Reduction in Office Hysteroscopy

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.

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Key information

Conditions

Hysteroscopy / Methods Lidocaine Infusion Placebo - Control

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Pain During Hysteroscopy Procedure Assessed by Visual Analog Scale (VAS)

    Time frame: 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.

  2. Number of Participants with Successful Access to the Uterine Cavity

    Time frame: 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 outcomes

  1. Visual Analog Scale (VAS) Pain Score 5 Minutes After the Procedure

    Time frame: 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.

  2. Change in Visual Analog Scale (VAS) Pain Score from Baseline to During the Procedure

    Time frame: 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.

  3. Completed procedure

    Time frame: 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.

  4. Patient satisfaction

    Time frame: 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.

  5. Adverse effect

    Time frame: During and up to 10 minutes after the procedure

    Recording any vasovagal symptoms observed or reported, including nausea, bradycardia, or hypotension.

Sponsors and collaborators

Lead sponsor

YAARA TABIB

Other

Registry information

Official study title

A Modified Technique of Target Lidocaine Infusion for Pain Control in Office Hysteroscopy: A Double-Blind Randomized Controlled

Acronym: OPTILID

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jan 5, 2026
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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