A Prospective Randomized Study Comparing Different Types of Local Anesthesia in Outpatient Procedural Hysteroscopy

MP-12-2023-3238

Hysteroscopy is a minimally invasive, diagnostic and therapeutic gynecological surgical technique and the gold standard in the study of the uterine cavity. Thanks to the decrease in the diameter of hysteroscopes and to the vaginoscopic approach, anesthesia is no longer necessary in diagnostic hysteroscopy. Nevertheless, in operative hysteroscopy, given the instrumentalization and the need of cervical dilation, the use of local anesthesia, with or without sedation, is recommended. The different alternatives described in the literature are the following: 1. Cervical/ intracervical block: injection of local anesthetic into the four quadrants of the cervix. 2. Paracervical block: injection of local anesthetic in the cervicovaginal junction at 5 and 7 o'clock positions. 3. Transcervical (uterine) anesthesia: instillation of a local anesthetic agent via catheter through the cervix and into the uterine cavity. 4. Topical cervical anesthesia: application of local anesthetic in gel or spray to the cervix. To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy, the investigators will perform a prospective multicentric study that compare two types of local anesthesia in outpatient procedural hysteroscopy: paracervical block, that is the actual gold-standard, and transcervical instillation.

2023-09-01

2024-09-01

2024-12-01

Not yet recruiting

242

Inclusion Criteria: * Female patients * 18 years of age or older * Indication of outpatient surgical hysteroscopy for polypectomy and myomectomy Exclusion Criteria: * Women under 18 years old * Unable to understand how to score a visual analog scale pain score * Hysteroscopy contraindication * Patients with medical history or current status that makes outpatient procedure usafe

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicentric, prospective, randomized trial, single-blinded, where eligible patients will be randomized to either receive paracervical or transcervical anesthesia before outpatient surgical hysteroscopy', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 242, 'type': 'ESTIMATED'}}

2023-08-01