Targeted Lidocaine Infusion for Pain Reduction in Office Hysteroscopy (OPTILID)

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

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 Overview

• Status: Not yet recruiting
• Conditions: Hysteroscopy / Methods; Placebo - Control; Lidocaine Infusion
• Intervention / Treatment: Other: Saline (0.9% NaCl); Drug: Lidocaine %2 ampoule

• Study Type: Interventional
• Enrollment (Estimated): 208
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group; Participants in this arm will receive 5 mL of normal saline infused through the internal cervical os immediately before office hysteroscopy.	Other: Saline (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.
Experimental: Lidocaine Group; Participants in this arm will receive 5 mL of 2% lidocaine infused through the internal cervical os immediately before office hysteroscopy.	Drug: Lidocaine %2 ampoule; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	During the hysteroscopy procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Immediately after the procedure
Adverse effect	Recording any vasovagal symptoms observed or reported, including nausea, bradycardia, or hypotension.	During and up to 10 minutes after the procedure

Collaborators and Investigators

• Sponsor: YAARA TABIB

Publications and helpful links

General Publications

• Barel O, Preuss E, Stolovitch N, Weinberg S, Barzilay E, Pansky M. Addition of Lidocaine to the Distension Medium in Hysteroscopy Decreases Pain during the Procedure-A Randomized Double-blind, Placebo-controlled Trial. J Minim Invasive Gynecol. 2021 Apr;28(4):865-871. doi: 10.1016/j.jmig.2020.08.003. Epub 2020 Aug 14.
• Shankar M, Davidson A, Taub N, Habiba M. Randomised comparison of distension media for outpatient hysteroscopy. BJOG. 2004 Jan;111(1):57-62. doi: 10.1046/j.1471-0528.2003.00004.x.
• Sagiv R, Sadan O, Boaz M, Dishi M, Schechter E, Golan A. A new approach to office hysteroscopy compared with traditional hysteroscopy: a randomized controlled trial. Obstet Gynecol. 2006 Aug;108(2):387-92. doi: 10.1097/01.AOG.0000227750.93984.06.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2029

Study Registration Dates

• First Submitted: November 30, 2025
• First Submitted That Met QC Criteria: December 28, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 28, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride
• Other Study ID Numbers: 0220-25-HMO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD that underlie the results of the primary and secondary outcomes reported in any publication will be shared in anonymized format. Data will include coded patient level information and the data dictionary. Identifiable information will not be shared. Data will be available to qualified researchers upon request following publication of study results.
• IPD Sharing Time Frame: Data will be available starting 6 months after publication and for a period of 5 years
• IPD Sharing Access Criteria: Access will be granted to researchers with approved scientific proposals. Requests will be reviewed by the principal investigator and institutional review board. Data will be shared through secure institutional channels.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No