TRIAL TO ASSESS THE EFFICACY OF ANESTHESIA DURING OFFICE HYSTEROSCOPY

Phase 1

• Conditions: eed to do an office Hysteroscopy for any reason; MedDRA version: 20.0Level: PTClassification code 10050125Term: HysteroscopySystem Organ Class: 10022891 - Investigations; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2021-001182-21-ES
• Lead Sponsor: niversity Hospital Puerta de Hierro Majadahonda, Madrid, Spain

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-14
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 106

Inclusion Criteria

- To be women, over 18 years old, with an indication to perform an office hysteroscopy, either for diagnostic or therapeutic purposes
- Having correctly taken the prescribed premedication consisting of 1 tablet of 10mg Buscopina, an Ibuprofen 600mg or Naproxen 500mg and a Diazepam of 5mg in women weighing less or equal to 70kg or 10mg in women weighing more than 70kg.
- They must be legally competent and able to understand, sign and date the informed consent form.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 96
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Women with a history of allergy or intolerance to Mepivacaine or other local anesthetics
- Women with contraindication or inability to collaborate when performing an office hysteroscopy
- Women with a history of chronic pelvic pain or deep endometriosis or carriers of the Essure® device
- Women taking analgesia as a chronic treatment, that is, continuously daily for at least 6 months
- Need to perform any procedure using the Myosure® device
- Inability to understand the nature of the study and give written informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate pain reduction during an office hysteroscopy by applying paracervical Mepivacaína 2% prior to the procedure;Secondary Objective: To evaluate pain caused by the infiltration of Mepivacaína <br>To evaluate pain during the entrance of the Hysteroscope to the endometrial cavity<br>To describe the side effects caused by Mepivacaína and the adverse events occured during the office hysteroscopy<br>To analyze the groups of patients with a higher pain risk and who would benefit more of the appliance of Mepivacaína;Primary end point(s): The overall pain of the patients will be evaluated during the hysteroscopy in the office using a visual analog pain scale (VAS) scoring from 1 to 10.;Timepoint(s) of evaluation of this end point: This scale will be passed on to the patients at the end of the intervention and the overall pain intensity will be asked.