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Completed
NCT05610371
Intrauterine Anesthesia in Operative, Awake, Office Hysteroscopy. A Randomized Double-blind Placebo-controlled Trial
Conditions: Anesthesia, Local, Office Hysteroscopy
Sex: Female
Ages: 20 Years – 52 Years
Phase: NA
Enrollment: 100
Sponsor: Assuta Ashdod Hospital
Location: Israel
Summary
Objective: to evaluate intrauterine lidocaine infusion effectiveness in reducing pain associated with operative, awake office hysteroscopy Methods: A total of 100 patients will be randomized for this study The control group underwent hysteroscopy using a saline distension medium.
The study group underwent hysteroscopy using 10ml of 2% lidocaine that was added to the first liter of distension medium.
Patients quantified their pain using a 0-10 VAS score, at the following five predefined points: baseline, before the procedure; while inserting the hysteroscope through the cervix; during the operative procedure; immediately after the procedure and 15 minutes following the procedure.
Eligibility Criteria
Inclusion Criteria:• Women between the ages of 20 years - 52 years inclusive.Undergoing SATH office hysteroscopyPatients are able to provide written consentExclusion Criteria:• Previous Pelvic Inflammatory Disease (PID) or documented tubal occlusionInability to consent due to cognitive or language barrierAllergy to LidocaineDocumented failed hysteroscopy prior to the current referral
Source: ClinicalTrials.gov (NCT05610371). StuddyBuddy aggregates publicly available trial information.