Targeted Lidocaine Infusion for Pain Reduction in Office Hysteroscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lidocaine %2 ampoule, Saline (0.9% NaCl).
- Who it may be relevant to
- Registry conditions: Hysteroscopy / Methods, Lidocaine Infusion, Placebo - Control. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Modified Technique of Target Lidocaine Infusion for Pain Control in Office Hysteroscopy: A Double-Blind Randomized Controlled
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Pain During Hysteroscopy Procedure Assessed by Visual Analog Scale (VAS) [Time frame: Immediately during the hysteroscopy procedure]
- Number of Participants with Successful Access to the Uterine Cavity [Time frame: During the hysteroscopy procedure]
Secondary outcome measures (5)
- Visual Analog Scale (VAS) Pain Score 5 Minutes After the Procedure [Time frame: 5 minutes after completion of the hysteroscopy procedure]
- 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.]
- Completed procedure [Time frame: During the hysteroscopy procedure]
- Patient satisfaction [Time frame: Immediately after the procedure]
- Adverse effect [Time frame: During and up to 10 minutes after the procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
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. PMID 32798723
- 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. PMID 14687053
- 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. PMID 16880310
Identifiers
NCT: NCT07318285 · 0220-25-HMO