Targeted Lidocaine Infusion for Pain Reduction in Office Hysteroscopy

NCT ID: NCT07318285

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2029-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hysteroscopy / Methods Lidocaine Infusion Placebo - Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lidocaine Group

Participants in this arm will receive 5 mL of 2% lidocaine infused through the internal cervical os immediately before office hysteroscopy.

Group Type EXPERIMENTAL

Lidocaine %2 ampoule

Intervention Type 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.

Control Group

Participants in this arm will receive 5 mL of normal saline infused through the internal cervical os immediately before office hysteroscopy.

Group Type PLACEBO_COMPARATOR

Saline (0.9% NaCl)

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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YAARA TABIB

OTHER

Sponsor Role lead

Responsible Party

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YAARA TABIB

Principal Investigator, Obstetrics and Gynecology Research Unit, Hadassah Medical Center

Responsibility Role SPONSOR_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 32798723 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14687053 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16880310 (View on PubMed)

Other Identifiers

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0220-25-HMO

Identifier Type: -

Identifier Source: org_study_id

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