[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594156":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":57,"collaborators":26,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":26,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":79,"whyStopped":26,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"GCS Ramsay Santé pour l'Enseignement et la Recherche","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pudendal block guided by neurostimulation","ACTIVE_COMPARATOR","Neurostimulation involves using an electrical impulse to trigger a nerve signal and a specific motor response. A short-bevel, insulated 80 mm needle connected to a neurostimulator is used. The puncture point lies midway between the ischial tuberosity and the anus. Stimulation starts at 2.5 mA, 1 Hz, and the needle is advanced 4-5 cm until anal sphincter contraction occurs (\"anal wink\"). The needle is adjusted to maintain the response while reducing intensity to 0.5 mA. If lost, intensity is increased; if too intense at 0.3 mA, the needle is repositioned. After confirming no vascular puncture, 1 mL of Ropivacaine 3.5 mg\u002FmL is injected to stop contraction, followed by slow injection of 15 mL total. The procedure is repeated on the other side. If no motor response occurs, a blind injection is performed after negative aspiration at 5 cm depth using the same landmarks.",[13],"Procedure: Neurostimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Pudendal block guided by ultrasound","EXPERIMENTAL","A 6 MHz convex probe is placed in the frontal plane along the line between the ischial tuberosity and the anal margin to visualize the bony prominence. The pudendal artery and nearby nerves are identified using color Doppler. A 22-gauge, 80 mm echogenic needle is inserted out-of-plane in front of the probe, targeting the lateral ischioanal fossa just medial to the pudendal artery, if visible. The probe is adjusted to center the artery. Block confirmation is based on ultrasound visualization of local anesthetic spreading into the fatty tissue medial to the pudendal artery. The procedure is repeated on the other side. If the artery is not visible, the injection is performed after negative aspiration on the medial aspect of the ischial tuberosity, along the line to the anus, at a depth of 4-5 cm.",[19],"Procedure: Ultrasound",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Neurostimulation","Procedure guided by neurostimulation",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Ultrasound","Procedure guided by ultrasound",[15],[32],{"name":33,"affiliation":34,"role":35},"Thomas GIRAL, MD","Hôpital privé Claude Galien","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","01 69 39 15 53","33","thomasgiral@gmail.com",[43],{"facility":44,"status":26,"city":45,"state":26,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Hôpital Privé Claude Galien","Quincy-sous-Sénart","91480","France","FR",{"type":50,"coordinates":51},"Point",[52,53],2.53419,48.67294,{"lat":53,"lon":52},[56],{"name":33,"role":38,"phone":39,"phoneExt":40,"email":41},{"type":58,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100594156","evaluation-of-the-analgesic-efficacy-of-an-ultrasound-guided-transperineal-pudendal-block-in-outpatient-hemorrhoidal-surgery-100594156",false,"NCT07015775","Evaluation of the Analgesic Efficacy of an Ultrasound-guided Transperineal Pudendal Block in Outpatient Hemorrhoidal Surgery","BACH","Inclusion Criteria:\n\n* Adult male or female patient\n* Patient who has signed informed consent to participate in the study\n* Patient scheduled for outpatient hemorrhoidal surgery under general anesthesia\n\nExclusion Criteria:\n\n* History of hemorrhoidal surgery\n* Allergy or contraindication to any of the medications used in the study\n* Patient undergoing surgery under spinal anesthesia\n* History of chronic pain requiring opioid use, unrelated to hemorrhoids\n* Mental impairment or any other condition that could hinder understanding or strict adherence to the protocol\n* Patient not affiliated with the French national health insurance system\n* Patient under legal protection (e.g., guardianship, trusteeship, or court protection)\n* Pregnant woman or woman at risk of being pregnant (i.e., of childbearing age without effective contraception and without an HCG test)\n* Patient already enrolled in another therapeutic clinical trial or within the exclusion period of another clinical trial","ALL","18 Years",{"count":69,"type":70},202,"ESTIMATED","INTERVENTIONAL",[73],"NA","In a population of patients undergoing hemorrhoidal surgery under general anesthesia and divided into two equal groups based on the method used for intraoperative pudendal nerve block and its branches in the ischioanal fossa:\n\nGroup 1: Pudendal block guided by neurostimulation Group 2: Pudendal block guided by ultrasound\n\nThe primary objective of this study is to compare the maximum immediate postoperative pain score between the two groups (pain reported by the patients in the recovery room on a simple numeric scale before morphine titration).",[76],"Hemorrhoids",[78],"hemorroidal surgery","NOT_YET_RECRUITING","2025-06-03",{"date":82,"type":83},"2025-06-11","ACTUAL",{"date":85,"type":70},"2025-08-01",{"date":87,"type":70},"2026-08-08",{"name":5,"class":6},1]