Targeted Lidocaine Infusion for Pain Reduction in Office Hysteroscopy
NCT ID: NCT07318285
Last Updated: 2026-01-05
Study Results
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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NOT_YET_RECRUITING
NA
208 participants
INTERVENTIONAL
2026-02-01
2029-12-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
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.
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.
Control Group
Participants in this arm will receive 5 mL of normal saline infused through the internal cervical os immediately before office hysteroscopy.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Referred for outpatient diagnostic or operative (see-and-treat) hysteroscopy
* Able and willing to provide written informed consent
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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YAARA TABIB
OTHER
Responsible Party
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YAARA TABIB
Principal Investigator, Obstetrics and Gynecology Research Unit, Hadassah Medical Center
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.
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.
Other Identifiers
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0220-25-HMO
Identifier Type: -
Identifier Source: org_study_id
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