[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606655":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":37,"centralContacts":42,"locations":46,"responsibleParty":52,"collaborators":46,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":46,"enrollmentInfo":65,"targetDuration":46,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":78,"overallStatus":86,"whyStopped":46,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":46},{"fullName":5,"class":6},"Maimónides Biomedical Research Institute of Córdoba","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","PLACEBO_COMPARATOR","Patients in the control group will undergo a placebo-like intervention in which the vagina and cervix will be irrigated with 0.9% normal saline using a syringe, simulating the motion and timing of the anesthetic application without actual injection. This aims to reduce expectation bias. No active anesthetic agent will be used.\n\nIntervention Type: Placebo Comparator Substance: Saline (0.9% sodium chloride) Route: Vaginal and cervical irrigation Purpose: To serve as the control arm for comparison of pain levels in patients not receiving anesthetic injections.",[13],"Other: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Local Anesthesia (Mepivacaine 3%)","EXPERIMENTAL","Patients in this group will receive an injection of 3% mepivacaine into the uterosacral ligaments before undergoing diagnostic hysteroscopy. The anesthetic will be administered using a 25 mm Carpule needle, with 3.4 mL injected into each uterosacral ligament under standard gynecological positioning. The procedure will begin approximately one minute after administration to allow time for the anesthetic effect.\n\nIntervention Type: Drug Drug Name: Mepivacaine 3% Dose and Route: Local injection - 6.8 mL total (3.4 mL per side) Purpose: To assess the effect of local anesthesia on pain perception during outpatient hysteroscopy.",[19],"Procedure: Local paracervical Anesthesia",[21,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Local paracervical Anesthesia","1\\. Intervention Group (Local Anesthesia) Name: Mepivacaine 3% uterosacral ligament block Type: Pharmacological (local anesthetic).\n\nDose\u002FAdministration:\n\nDrug: Mepivacaine hydrochloride 3% (4 vials of 1.7 mL each, total 6.8 mL). Route: Bilateral injection into uterosacral ligaments (2 injections per ligament, 3.4 mL per side).\n\nTechnique:\n\nPatient in lithotomy position. Uterosacral ligaments identified posteriorly to the cervix. Injection with a 27G Carpule needle (25 mm length) at 2-3 mm depth. Slow infusion (to minimize dispersion). Timing: Administered ≥1 minute before hysteroscopy.",[15],[27,28,29],"local anesthesia","mepivacaine","Mepivacaine 3% uterosacral ligament block",{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Placebo","Procedure:\n\nVaginal and cervical irrigation with 0.9% saline solution (4 irrigations, mimicking anesthesia administration).\n\nMimicry:\n\nSame equipment (syringe, speculum) as intervention group. Identical patient positioning and timing",[9],[35,36],"Saline irrigation (sham procedure)","Non-pharmacological",[38],{"name":39,"affiliation":40,"role":41},"Jorge Garcia Fernandez, MD, Principal Investigator","MD Obstetrics and Gynecology Reina Sofia Hospital, Cordoba, Spain","PRINCIPAL_INVESTIGATOR",[43,48],{"name":39,"role":44,"phone":45,"phoneExt":46,"email":47},"CONTACT","+34 622595644",null,"jorgarciafernan@gmail.com",{"name":49,"role":44,"phone":50,"phoneExt":46,"email":51},"Paula Caballero, MD, Collaborator, Investigator","+34 617798032","paulacaballero.r@gmail.com",{"type":41,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":46,"oldOrganization":46},"Paula Caballero","MD Obstetrics and Gynecology Reina Sofia Hospital","100606655","hysteroscopy-anesthesia-for-relief-of-pain-100606655",false,"NCT07178379","Hysteroscopy Anesthesia for Relief of Pain","HARP Trial: Hysteroscopy Anesthesia for Relief of Pain","HARP","Inclusion Criteria\n\n* Age ≥ 18 years: To ensure that participants are legal adults and able to provide informed consent.\n* Indication for office-based diagnostic hysteroscopy: The patient must be scheduled for a diagnostic hysteroscopy, either for uterine cavity evaluation or diagnostic purposes.\n* Simple procedures like uterine polypectomies involving 1, 2, or more than 3 polyps or endometrial biopsy\n* No previous hysteroscopies\n\nExclusion Criteria\n\n* Age \\\u003C 18 years\n* Known allergy to any local anesthetic\n* General contraindications to hysteroscopy including pregnancy (established via interview, last menstrual period, contraceptive use, or pregnancy test), active infection (e.g., pyometra or recent pelvic inflammatory disease), recent uterine perforation, etc.\n* Complex procedures like myomectomy with morcellator\n* Failure to access the uterine cavity\n* Anatomic conditions preventing cavity access\n* Excessive procedure duration or fluid use (fluid deficit \\> 1000 cc)\n* Known uterine malformations\n* Waiting times exceeding 60 minutes\n* Use of analgesic medication prior to the procedure\n* Major complications related to the procedure including uterine perforation, creation of a false passage, or significant bleeding requiring interventions beyond standard care.\n* Incomplete delivery of informed consent or failure to complete the pre-procedure anxiety questionnaire.","FEMALE","18 Years",{"count":66,"type":67},70,"ESTIMATED","INTERVENTIONAL",[70],"NA","This randomized clinical trial aims to evaluate the effect of local anesthesia on pain perception in patients undergoing outpatient diagnostic hysteroscopy. Although generally well tolerated, pain during hysteroscopy remains a leading cause of procedural failure and patient discomfort. Current evidence on the effectiveness of local anesthetic techniques is limited, with considerable variability in study designs, patient populations, and outcomes measured.\n\nThis study will compare pain levels between two groups: one receiving local anesthetic infiltration (3% mepivacaine into the uterosacral ligaments), and the other undergoing a placebo-like intervention (saline irrigation without injection). Pain will be assessed using a standardized Visual Analog Scale (VAS).\n\nThe primary objective is to determine whether local anesthesia significantly reduces pain perception during the procedure. Secondary objectives include evaluating which patient or procedural variables may influence pain (e.g., parity, uterine position, BMI, operator experience) and whether local anesthesia impacts the need for post-procedural analgesia or complication rates.\n\nPatients will be randomly assigned in a 1:1 ratio using a simple randomization method. Although the study design does not allow for double blinding, efforts will be made to minimize expectation bias-patients will not be explicitly informed whether they are receiving anesthesia or not, and the placebo group will receive simulated intervention. The principal investigator and the statistician will be blinded to the treatment allocation during data analysis.\n\nInclusion criteria are: age ≥ 18 years, indication for office-based diagnostic hysteroscopy or minor operative procedures (e.g., polypectomy or biopsy), and no previous hysteroscopy experience. Exclusion criteria include known anesthetic allergy, complex procedures (e.g., myomectomy), anatomic uterine malformations, severe complications, or lack of consent.\n\nA total sample size of 58 patients (29 per group) has been calculated based on an expected clinically relevant VAS difference of 1.5 points and a standard deviation of 2.0. To account for possible dropouts, up to 70 patients may be enrolled.\n\nThe results of this trial will provide higher quality evidence on whether local anesthesia should be routinely recommended in outpatient hysteroscopy and may support cost-effectiveness studies in the future.",[73,74,75,76,77],"Pain Management","Outpatient Hysteroscopy","Local Anesthesia","Procedural Pain Relief","Gynecologic Procedure",[79,80,81,82,83,84,85],"hysteroscoy","outpatient hysteroscopy","pain assessment","visual analog scale","localanesthesia","ambulatory surgery","randomized controlled trial","NOT_YET_RECRUITING","2025-09-10",{"date":89,"type":90},"2025-09-17","ACTUAL",{"date":92,"type":67},"2025-09-06",{"date":94,"type":67},"2025-12-31",{"name":5,"class":6}]