[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657626":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":25,"interventions":38,"overallOfficials":13,"centralContacts":48,"locations":54,"responsibleParty":70,"collaborators":13,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":13,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":57,"whyStopped":13,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Erol Olcok Corum Training and Research Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Change in serum TLR4 concentration from baseline to 24 hours after surgery","Serum Toll-like receptor 4 (TLR4) concentration will be measured by ELISA before the intervention (baseline, T0) and 24 hours after surgery (T4). The primary outcome is the change in TLR4 concentration between T0 and T4, compared between the SPSIP block and sham-control groups.","Baseline (preoperative) to 24 hours after surgery",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"RANDOMIZED","PARALLEL","Participants will be randomly assigned in a 1:1 ratio to either the SPSIP block group or the sham block group. Both groups will receive standardized general anesthesia and postoperative analgesia.","SUPPORTIVE_CARE",{"masking":20,"maskingDescription":21,"whoMasked":22},"DOUBLE","Participants and outcome assessors will be blinded to group allocation. The anesthesiologist performing the SPSIP or sham procedure will not be blinded because of the nature of the intervention.",[23,24],"PARTICIPANT","OUTCOMES_ASSESSOR",[26,32],{"label":27,"type":28,"description":29,"interventionNames":30},"SPSIP Block Group","EXPERIMENTAL","Participants will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block with local anesthetic before induction of general anesthesia, in addition to standardized general anesthesia and postoperative analgesia.",[31],"Procedure: Serratus posterior superior intercostal plane block",{"label":33,"type":34,"description":35,"interventionNames":36},"Sham Block Group","SHAM_COMPARATOR","Participants will undergo a simulated ultrasound-guided SPSIP procedure without local anesthetic injection before induction of general anesthesia, in addition to standardized general anesthesia and postoperative analgesia.",[37],"Procedure: Sham SPSIP Procedure",[39,44],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":13},"PROCEDURE","Serratus posterior superior intercostal plane block","The SPSIP block will be performed preoperatively in the sitting position under ultrasound guidance using a linear 6-13 MHz transducer and an in-plane needle approach. Local anesthetic will be injected into the serratus posterior superior intercostal plane according to the study protocol.",[27],{"type":40,"name":45,"description":46,"armGroupLabels":47,"otherNames":13},"Sham SPSIP Procedure","A simulated ultrasound-guided SPSIP procedure will be performed in the sitting position using the same positioning and ultrasound preparation as the SPSIP block group, but no local anesthetic will be injected.",[33],[49],{"name":50,"role":51,"phone":52,"phoneExt":13,"email":53},"Mucahide Emine Fidancı Kuas, MD","CONTACT","+90-553-204-9918","efidanci02@gmail.com",[55],{"facility":56,"status":57,"city":58,"state":58,"zip":59,"country":60,"countryCode":13,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Hitit University Erol Olçok Training and Research Hospital","RECRUITING","Çorum","19040","Turkey (Türkiye)",{"type":62,"coordinates":63},"Point",[64,65],34.95333,40.54889,{"lat":65,"lon":64},[68],{"name":50,"role":51,"phone":69,"phoneExt":13,"email":53},"+90-553-205-9918",{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"SPONSOR_INVESTIGATOR","Mucahide Emine Fidancı Kuas","Resident Physician, Department of Anesthesiology and Reanimation","100657626","effects-of-spsip-block-on-perioperatve-inflammation-and-tlr4-in-breast-cancer-surgery-100657626",false,"NCT07843212","Effects of SPSIP Block on Perioperative Inflammation and TLR4 in Breast Cancer Surgery","Effects of Serratus Posterior Superior Intercostal Plane Block on Perioperative Inflammatory Response and TLR4-Mediated Innate Immune Activation in Breast Cancer Surgery: A Prospective, Randomized, Double-Blind, Sham-Controlled Trial","SPSIP-TLR4","Inclusion Criteria:\n\n* Female patients aged 18 to 85 years.\n* Scheduled for elective breast cancer surgery under general anesthesia.\n* American Society of Anesthesiologists (ASA) physical status I-III.\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Refusal to participate or inability to provide informed consent.\n* Allergy or contraindication to the study local anesthetic.\n* Coagulopathy or ongoing anticoagulant treatment contraindicating regional anesthesia.\n* Infection at the planned injection site.\n* Pre-existing chronic pain condition or regular opioid use.\n* Inability to communicate pain scores or comply with study assessments.",true,"FEMALE","18 Years","85 Years",{"count":87,"type":88},80,"ESTIMATED","INTERVENTIONAL",[91],"NA","This study will investigate whether the serratus posterior superior intercostal plane (SPSIP) block improves postoperative recovery after breast cancer surgery.\n\nParticipants will be randomly assigned to one of two groups. One group will receive an ultrasound-guided SPSIP block, while the other group will undergo a similar procedure without active medication (sham procedure). Both groups will receive standard general anesthesia and postoperative pain management.\n\nPostoperative pain intensity, need for additional pain medication, nausea and vomiting, length of hospital stay, and persistent pain at 3 months after surgery will be assessed. Blood samples collected before surgery and at predetermined postoperative time points will be used to evaluate the body's inflammatory response to surgery and innate immune system activity. These assessments will include toll-like receptor 4 (TLR4), an immune-system marker, and selected inflammatory markers.\n\nThe main question of this study is whether the SPSIP block, compared with the sham procedure, reduces the surgery-related inflammatory response and improves postoperative pain outcomes.",[94,95,96],"Serratus Posterior Superior Intercostal Plane Block (SPSIPB)","Breast Cancer","Toll-Like Receptors",[98,99,100,101,102,103],"serratus posterior superior intercostal plane block","SPSIP block","postoperative pain","inflammatory response","Toll-like receptor 4","breast surgery","2026-10-06",{"date":106,"type":107},"2026-10-09","ACTUAL",{"date":109,"type":107},"2026-07-14",{"date":111,"type":88},"2027-01-30",{"name":72,"class":6},1]