[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565435":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":23,"responsibleParty":47,"collaborators":7,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":7,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":7,"enrollmentInfo":60,"targetDuration":7,"studyType":63,"phases":7,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":26,"whyStopped":7,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Ospedale Santa Maria Goretti","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"PROCEDURE","ESP block","The ESPB will be performed at the T4 level, monolaterally (according to the surgical side), with 30ml volume of 0.5% Ropivacaine injected with a 20-gauge, 50-mm-long needle. The technique used is the standard ultrasound-guided, sterile procedure.\n\nSoon after performing the block, a timer will be started to mark the time for subsequent evaluations. At 1,3,5 and after every 5 minutes following the block until 40 minutes or until general anaesthesia is induced, the cold sensitivity of the chest will be explored.",[14,19],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Irene Lupelli, MD","CONTACT","+39 3497772231","irene.lupelli@gmail.com",{"name":20,"role":16,"phone":21,"phoneExt":7,"email":22},"Alessandro De Cassai, MD","+39 3204169392","alessandro.decassai@gmail.com",[24],{"facility":25,"status":26,"city":27,"state":28,"zip":29,"country":28,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":37},"Ospedale Santa Maria Goretti, Via Lucia Scaravelli","RECRUITING","Latina","Italy","04100","IT",{"type":32,"coordinates":33},"Point",[34,35],12.9043,41.46614,{"lat":35,"lon":34},[38,39,43,44,45],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},{"name":40,"role":16,"phone":41,"phoneExt":7,"email":42},"Giorgio Panfili, MD","+ 39 3201876689","giorgio.panfili91@gmail.com",{"name":15,"role":16,"phone":7,"phoneExt":7,"email":7},{"name":40,"role":16,"phone":7,"phoneExt":7,"email":7},{"name":46,"role":16,"phone":7,"phoneExt":7,"email":7},"Luca Gentili, MD",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"PRINCIPAL_INVESTIGATOR","Irene Lupelli","Doctor","100565435","onset-of-sensory-block-after-thoracic-esp-block-100565435",false,"NCT06642142","Onset of Sensory Block After Thoracic ESP Block","Evaluation of the Onset and the Extent of Sensory Block After Thoracic ESP Block in Breast Surgery - a Prospective Observational Study","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* ASA score I-II-III.\n* Schedule of breast surgery\n* Schedule of ESPB\n* Consent to the study\n\nExclusion Criteria:\n\n* Allergy to local anaesthetics\n* Cardiopathies, nephropathies, hepatopathies, central or peripheral neuropathies uncompensated\n* Infection at the injection site\n* Uncooperative patient\n* BMI \\\u003C 20, \\> 40\n* Difficulty in visualising target structures or the LA spread (failure of technique)\n* Pregnancy status","ALL","18 Years",{"count":61,"type":62},30,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to to evaluate the changes in cold sensitivity and the onset of sensory block after performing a thoracic ESP block. It reflects the time it takes for the local anaesthetic to spread into the paravertebral space leading to changes in cold sensitivity in the chest.\n\nThe study population are patients undergoing simple quadrantectomy or partial resection with or without sentinel lymphnode removal, in the operating rooms of Santa Maria Goretti Hospital in Latina.\n\nThis study is observational because it simply describes and records the effects of a procedure (the ESP block) on treated patients during a period of observation.\n\nBefore surgery, unilateral thoracic ESP block (T4 level) with a sterile, ultrasound-guided technique will be performed. A timer will be started to mark the time for subsequent evaluations. At 1,3,5 and after every 5 minutes following the block up to 40 minutes or until induction of general anaesthesia, the cold sensitivity of the chest will be explored.",[66,67],"Breast Cancer Surgery","ESPB",[67],"2024-11-07",{"date":71,"type":72},"2024-11-08","ACTUAL",{"date":69,"type":72},{"date":75,"type":62},"2025-10",{"name":5,"class":6},1]