RANDOMIZED, UNICENTRIC, DOUBLE BLIND, PLACEBO-CONTROLLED TRIAL TO ASSESS THE EFFICACY OF PARACERVICAL ANESTHESIA FOR PAIN CONTROL DURING AN OFFICE HYSTEROSCOPY

INTERVENTION: Trade Name: Mepivacaína Product Name: Mepivacaína Product Code: 65298 Pharmaceutical Form: Solution for injection INN or Proposed INN: MEPIVACAINE CAS Number: 96‐88‐8 Current Sponsor code: 65298 Other descriptive name: MEPIVACAINE NORMON Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 30‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Infiltration CONDITION: Need to do an office Hysteroscopy for any reason ; MedDRA version: 20.0 Level: PT Classification code 10050125 Term: Hysteroscopy System Organ Class: 10022891 ‐ Investigations Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Diagnosis [E01] PRIMARY OUTCOME: Main Objective: To evaluate pain reduction during an office hysteroscopy by applying paracervical Mepivacaína 2% prior to the procedure 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. Secondary Objective: To evaluate pain caused by the infiltration of Mepivacaína ; To evaluate pain during the entrance of the Hysteroscope to the endometrial cavity; To describe the side effects caused by Mepivacaína and the adverse events occured during the office hysteroscopy; To analyze the groups of patients with a higher pain risk and who would benefit more of the appliance of Mepivacaína 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. SECONDARY OUTCOME: Secondary end point(s): 1. Pain during administration of paracervical anesthesia. The overall pain of the patients will be evaluated using a visual analog pain scale (VAS) scoring from 1 to 10.; 2. Pain during entry into the endometrial cavity with the hysteroscope. The global pain of the patients will be evaluated using a visual analogue pain scale (VAS) scoring from 1 to 10.; 3. Patient demographic data. The following patient data will be recorded: age, parity (history of childbirth, caesarean section or abortion), if the patient is premenopausal or postmenopausal, previous treatments, surgical history especially curettage or surgeries on the uterine cervix, indication of hysteroscopy, type of hysteroscopy performed (diagnostic or surgical), the duration of the procedure as well as the average pressure needed during it.; 4. Side effects derived from the administration of Mepivacaine 2%; 5. Adverse events during hysteroscopy Timepoint(s) of evaluation of this end point: 1. This scale will be passed on to the patients immediately after the administration of the anesthetic; 2. This scale will be passed on to patients after the first entry to the; endometrial cavity with the hysteroscope.; 3. Before starting the procedure; 4 and 5. After finishing the procedure. 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