drugset / Trial / NCT05610371

Intrauterine Anesthesia in Operative, Awake, Office Hysteroscopy. A Randomized Double-blind Placebo-controlled Trial

NCT05610371 ↗

Completed 100 enrolled Assuta Ashdod Hospital
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2019-08-01
Primary completion
2022-05-01
Completion
2022-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Lidocaine Other / unclassified 2 % —
Subject Lidocaine Other / unclassified 10 ml —

Indications

No indication recorded.