[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649840":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":25,"responsibleParty":44,"collaborators":25,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":50,"sex":56,"minAge":57,"maxAge":25,"enrollmentInfo":58,"targetDuration":25,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":75,"whyStopped":25,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":25},{"fullName":5,"class":6},"Aydin Adnan Menderes University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"PECS II Block + Standard Local Infiltration","EXPERIMENTAL","Participants will receive an ultrasound-guided PECS II block with 20 mL of 0.25% bupivacaine before the procedure, followed by standard local infiltration anesthesia with 1% lidocaine during elective permanent pacemaker implantatio",[13,14],"Other: Ultrasound-Guided PECS II Block","Other: Standard Local Infiltration Anesthesia",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard Local Infiltration","ACTIVE_COMPARATOR","Participants will receive standard local infiltration anesthesia with 1% lidocaine during elective permanent pacemaker implantation without PECS II block.",[14],[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Ultrasound-Guided PECS II Block","Ultrasound-guided PECS II block will be performed before permanent pacemaker implantation using 20 mL of 0.25% bupivacaine. The local anesthetic will be injected between the pectoralis major and pectoralis minor muscles and between the pectoralis minor and serratus anterior muscles under ultrasound guidance.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Standard Local Infiltration Anesthesia","Standard local infiltration anesthesia will be administered by the implanting physician using 1% lidocaine at the incision site and pacemaker pocket according to routine clinical practice.",[9,16],[31],{"name":32,"affiliation":33,"role":34},"Ferdi Gulasti","Aydın Adnan Menderes University Hospital","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Ferdi Gulasti, MD","CONTACT","+905054929650","ferdigulasti@gmail.com",{"name":42,"role":38,"phone":25,"phoneExt":25,"email":43},"SEVİL GÜLAŞTI, MD","drsevilonay@hotmail.com",{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","ferdi gülaştı","Aydin Adnan Menderes University Faculty of Medicine","100649840","ultrasound-guided-pecs-ii-block-for-permanent-pacemaker-implantation-100649840",false,"NCT07739407","Ultrasound-Guided PECS II Block for Permanent Pacemaker Implantation","The Contribution of Ultrasound-Guided PECS II Block to Standard Local Infiltration Anesthesia During Elective Permanent Pacemaker Implantation: A Prospective Randomized Controlled Trial","PACE-PECS","Inclusion Criteria:\n\n* Age 18 years or older.\n* Scheduled for elective permanent pacemaker implantation.\n* American Society of Anesthesiologists (ASA) physical status I-III.\n* Ability to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Infection at the planned block site.\n* Known allergy or hypersensitivity to local anesthetics.\n* Uncorrected coagulopathy or active bleeding disorder.\n* Contraindication to PECS II block because of anticoagulant or antiplatelet therapy.\n* Severe cognitive impairment or inability to use the Numerical Rating Scale (NRS).\n* Emergency pacemaker implantation.\n* Planned generator replacement, lead revision, or device revision procedure.\n* Anatomical abnormalities preventing safe block performance.\n* Refusal to participate in the study.","ALL","18 Years",{"count":59,"type":60},72,"ESTIMATED","INTERVENTIONAL",[63],"NA","This single-center, prospective, randomized, controlled clinical trial aims to evaluate whether ultrasound-guided PECS II block, when added to standard local infiltration anesthesia, improves perioperative analgesia in patients undergoing elective permanent pacemaker implantation.\n\nSeventy-two adult patients scheduled for elective permanent pacemaker implantation will be randomly assigned in a 1:1 ratio to receive either ultrasound-guided PECS II block plus standard local infiltration anesthesia or standard local infiltration anesthesia alone. The primary outcome is pain intensity during pacemaker pocket creation measured using the Numerical Rating Scale (NRS). Secondary outcomes include intraoperative pain scores, additional local anesthetic, opioid and sedative requirements, postoperative pain scores, analgesic consumption during the first 24 hours, patient and operator satisfaction, procedure duration, and procedure-related complications. The study is designed to determine whether PECS II block provides additional analgesic benefit during permanent pacemaker implantation.",[66,67,68],"Cardiac Pacing","Permanent Pacemaker Implantation","Postoperative Pain",[70,71,72,73,74],"PECS II Block","Permanent Pacemaker","Local Infiltration Anesthesia","Perioperative Analgesia","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-07-28",{"date":78,"type":79},"2026-07-31","ACTUAL",{"date":81,"type":60},"2026-08-05",{"date":83,"type":60},"2027-08-05",{"name":46,"class":6}]