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

• Status: Completed
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assuta Ashdod Hospital
• Treatments: Lidocaine

Criteria

Inclusion Criteria:

• • Women between the ages of 20 years - 52 years inclusive.

• Undergoing SATH office hysteroscopy

• Patients are able to provide written consent

Exclusion Criteria:

• • Previous Pelvic Inflammatory Disease (PID) or documented tubal occlusion

• Inability to consent due to cognitive or language barrier

• Allergy to Lidocaine

• Documented failed hysteroscopy prior to the current referral