[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656849":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":34,"studyPopulation":35,"armGroups":36,"interventions":52,"overallOfficials":30,"centralContacts":30,"locations":65,"responsibleParty":82,"collaborators":30,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":30,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":30,"studyType":98,"phases":30,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":67,"whyStopped":30,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Bursa Yuksek Ihtisas Training and Research Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Cumulative Tramadol Consumption During the First 24 Hours After Surgery","The total amount of tramadol consumed through the patient-controlled analgesia device will be recorded in milligrams at postoperative hour 24.","During the first 24 postoperative hours",[14,18,21,24,27],{"measure":15,"description":16,"timeFrame":17},"Numeric Rating Scale Pain Score at Rest","Pain intensity at rest will be assessed using a Numeric Rating Scale from 0 to 10, where 0 indicates no pain and 10 indicates the most severe pain.","At postoperative hours 0, 2, 4, 6, 12, and 24",{"measure":19,"description":20,"timeFrame":17},"Numeric Rating Scale Pain Score During Movement","Pain intensity during movement, including coughing or deep breathing, will be assessed using a Numeric Rating Scale from 0 to 10, where 0 indicates no pain and 10 indicates the most severe pain.",{"measure":22,"description":23,"timeFrame":17},"Dermatomal Extent of Sensory Block Assessed by Pinprick","Among participants in the block groups, sensory block will be assessed by pinprick, and the upper and lower dermatomal boundaries will be recorded.",{"measure":25,"description":26,"timeFrame":12},"Incidence of Postoperative Nausea and Vomiting","The occurrence of postoperative nausea and vomiting will be recorded for each participant.",{"measure":28,"description":29,"timeFrame":12},"Incidence of Block-Related Complications","Block-related complications will be recorded among participants in the block groups.",null,{"allocation":30,"interventionModel":30,"interventionModelDescription":30,"primaryPurpose":30,"observationalModel":32,"timePerspective":33,"maskingInfo":30},"COHORT","PROSPECTIVE","Patients aged 18 to 80 years who are scheduled for elective breast surgery under general anesthesia and meet the eligibility criteria will be enrolled after providing written informed consent. Group classification will reflect the regional analgesia approach selected as part of routine care by the treating anesthesiologist. The investigators will not participate in the selection of the anesthesia method, the fascial plane block, or the study group.\n\nThe study will include 90 participants in three observational cohorts: rhomboid intercostal plane block, serratus posterior superior intercostal plane block, and control. The primary outcome is cumulative tramadol consumption recorded by patient-controlled analgesia during the first 24 postoperative hours. Secondary assessments include Numeric Rating Scale pain scores at rest and during movement at postoperative hours 0, 2, 4, 6, 12, and 24; sensory block level assessed by pinprick testing in the block groups; postoperative nausea and vomiting; and block-related complications.","Participants aged 18 to 80 years who are scheduled for elective breast surgery under general anesthesia at the single study center, provide written informed consent, and meet all eligibility criteria.",[37,43,48],{"label":38,"type":30,"description":39,"interventionNames":40},"Rhomboid Intercostal Plane Block Group","Participants undergoing elective breast surgery who receive a rhomboid intercostal plane block as selected by the treating anesthesiologist during routine clinical care. The local anesthetic type and dose used for the block will be recorded.",[41,42],"Procedure: Rhomboid intercostal plane block","Procedure: Control Group",{"label":44,"type":30,"description":45,"interventionNames":46},"Serratus Posterior Superior Intercostal Plane Block Group","Participants undergoing elective breast surgery who receive a serratus posterior superior intercostal plane block as selected by the treating anesthesiologist during routine clinical care. The local anesthetic type and dose used for the block will be recorded.",[47,42],"Procedure: Serratus posterior superior intercostal plane block",{"label":49,"type":30,"description":50,"interventionNames":51},"Control Group","Participants undergoing elective breast surgery who are included in the control cohort as determined by routine clinical care. Investigators do not assign participants to this cohort and perform postoperative follow-up only.Participants managed with intravenous patient-controlled analgesia as selected by the responsible anesthesiologist during routine clinical care.",[42],[53,58,62],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":30},"PROCEDURE","Rhomboid intercostal plane block","A fascial plane block in which local anesthetic is injected into the plane between the rhomboid major and intercostal muscles. The treating anesthesiologist selects the technique as part of routine clinical care, and the type and dose of local anesthetic used are recorded.",[38],{"type":54,"name":59,"description":60,"armGroupLabels":61,"otherNames":30},"Serratus posterior superior intercostal plane block","A fascial plane block in which local anesthetic is injected into the plane between the serratus posterior superior and intercostal muscles. The treating anesthesiologist selects the technique as part of routine clinical care, and the type and dose of local anesthetic used are recorded.",[44],{"type":54,"name":49,"description":63,"armGroupLabels":64,"otherNames":30},"Participants managed with intravenous patient-controlled analgesia as selected by the responsible anesthesiologist during routine clinical care.",[49,38,44],[66],{"facility":5,"status":67,"city":68,"state":30,"zip":30,"country":69,"countryCode":30,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"RECRUITING","Bursa","Turkey (Türkiye)",{"type":71,"coordinates":72},"Point",[73,74],29.06013,40.19559,{"lat":74,"lon":73},[77],{"name":78,"role":79,"phone":80,"phoneExt":30,"email":81},"Korgün Ökmen","CONTACT","+90 505 708 10 21","korgunokmen@gmail.com",{"type":83,"investigatorFullName":78,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Professor of Anesthesiology and Reanimation","100656849","postoperative-analgesic-effectiveness-of-fascial-plane-blocks-in-breast-surgery-100656849",false,"NCT07830446","Postoperative Analgesic Effectiveness of Fascial Plane Blocks in Breast Surgery","Investigation of the Postoperative Effectiveness of Fascial Plane Blocks Used for Analgesia in Patients Undergoing Breast Surgery: A Prospective Observational Study","Inclusion Criteria:\n\n* Age 18 to 80 years\n* American society of anesthesiologists physical status I to III\n* Undergoing surgery under general anesthesia\n* Provision of written informed consent\n* Scheduled for elective breast surgery\n\nExclusion Criteria:\n\n* History of allergy to local anesthetic medications\n* Coagulation disorder\n* Body mass index greater than 40 kg\u002Fm2\n* Infection at the block application site\n* Chronic pain syndrome\n* Pregnancy\n* Inability to communicate\n* Requirement for emergency surgery","ALL","18 Years","80 Years",{"count":96,"type":97},90,"ESTIMATED","OBSERVATIONAL","This prospective, single-center observational study will compare postoperative pain control in adults undergoing elective breast surgery. Ninety participants will be evaluated in three groups based on routine clinical care: rhomboid intercostal plane block, serratus posterior superior intercostal plane block, and control. The anesthesia method and fascial plane block will be selected by the treating anesthesiologist, and the research team will not assign participants to a group. The main outcome is the total amount of tramadol used through patient-controlled analgesia during the first 24 hours after surgery. Pain scores at rest and during movement, sensory block levels, postoperative nausea and vomiting, and block-related complications will also be recorded.",[101],"Postoperative Pain",[103,104,105,106,107,108,109,110,111],"Breast Surgery","Postoperative Analgesia","Fascial Plane Block","Regional Anesthesia","Rhomboid Intercostal Plane Block","Serratus Posterior Superior Intercostal Plane Block","Patient-Controlled Analgesia","Numeric Rating Scale","Tramadol","2026-09-19",{"date":114,"type":115},"2026-09-23","ACTUAL",{"date":117,"type":115},"2026-04-01",{"date":119,"type":97},"2027-03-01",{"name":5,"class":6},1]