[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653232":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":56,"studyPopulation":45,"armGroups":57,"interventions":69,"overallOfficials":45,"centralContacts":81,"locations":87,"responsibleParty":102,"collaborators":45,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":45,"eligibilityCriteria":112,"healthyVolunteers":108,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":45,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":127,"overallStatus":133,"whyStopped":45,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Adiyaman University Research Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":45},[9],{"measure":10,"description":11,"timeFrame":12},"Postoperative Quality of Recovery Assessed by QoR-15T","Postoperative quality of recovery will be assessed using the Turkish version of the Quality of Recovery-15 questionnaire (QoR-15T). The QoR-15T consists of 15 items assessing multiple dimensions of postoperative recovery. The total score ranges from 0 to 150, with higher scores indicating better quality of recovery.","Postoperative 24 hours",[14,18,22,25,29,33,37,41],{"measure":15,"description":16,"timeFrame":17},"Total Postoperative Tramadol Consumption","Total postoperative tramadol consumption will be recorded as the cumulative amount of tramadol administered during the first 48 hours after surgery. Tramadol consumption will be reported in milligrams (mg).","From the end of surgery to postoperative 48 hours",{"measure":19,"description":20,"timeFrame":21},"Postoperative Pain Intensity","Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. VAS scores will be recorded at postoperative 2, 4, 6, 8, 10, 12, 24, 36, and 48 hours.","Postoperative 2, 4, 6, 8, 10, 12, 24, 36, and 48 hours",{"measure":23,"description":24,"timeFrame":21},"Number of Participants With Postoperative Nausea and\u002For Vomiting (PONV)","The occurrence of postoperative nausea and\u002For vomiting (PONV) will be assessed at postoperative 2, 4, 6, 8, 10, 12, 24, 36, and 48 hours. At each predefined time point, the presence or absence of nausea and\u002For vomiting will be recorded as a binary outcome (yes\u002Fno). The number of participants experiencing nausea and\u002For vomiting will be recorded and compared between the groups.",{"measure":26,"description":27,"timeFrame":28},"Intensive Care Unit Length of Stay","The duration of the first postoperative intensive care unit (ICU) stay will be recorded for each participant. ICU length of stay will be calculated from postoperative admission to the ICU until the first discharge from the ICU and will be reported in hours.","From postoperative ICU admission until first ICU discharge, an average of 7 days",{"measure":30,"description":31,"timeFrame":32},"Ward Length of Stay","The duration of postoperative ward stay will be recorded for each participant. Ward length of stay will be calculated from the first discharge from the intensive care unit to hospital discharge and will be reported in days.","From first ICU discharge until hospital discharge, an average of 14 days",{"measure":34,"description":35,"timeFrame":36},"Total Hospital Length of Stay","The total length of hospital stay will be recorded for each participant. Hospital length of stay will be calculated from the day of surgery until hospital discharge and will be reported in days.","From the day of surgery until hospital discharge, an average of 14 days",{"measure":38,"description":39,"timeFrame":40},"Total Duration of Surgery","The total duration of surgery will be recorded for each participant. Surgical duration will be defined as the time from the start of surgery to the completion of surgery and will be reported in minutes.","Intraoperative period, from the start to the end of surgery",{"measure":42,"description":43,"timeFrame":44},"Postoperative Extubation Time","Postoperative extubation time will be defined as the time from the end of surgery to removal of the endotracheal tube and will be recorded in hours.","From the end of surgery until extubation, an average of 24 hours",null,{"allocation":47,"interventionModel":48,"interventionModelDescription":49,"primaryPurpose":50,"observationalModel":45,"timePerspective":45,"maskingInfo":51},"RANDOMIZED","PARALLEL","Participants will be randomly assigned in a 1:1 ratio to two parallel groups: the SPSIP block group or the control group. Participants in the SPSIP block group will receive ultrasound-guided bilateral single-shot serratus posterior superior intercostal plane block in addition to standard perioperative care, while participants in the control group will receive standard perioperative care without the block.","TREATMENT",{"masking":52,"maskingDescription":53,"whoMasked":54},"SINGLE","Postoperative outcome assessments will be performed by an investigator who is blinded to group allocation. The anesthesiologist performing the SPSIP block will not be involved in postoperative outcome assessment.",[55],"OUTCOMES_ASSESSOR","This prospective, randomized, controlled study will include 50 adult patients undergoing elective cardiac surgery. Patients will be randomly allocated to either the SPSIP block group or the control group.\n\nIn the block group, an ultrasound-guided bilateral single-shot serratus posterior superior intercostal plane (SPSIP) block will be performed in addition to the standard perioperative analgesic management. Patients in the control group will receive standard perioperative analgesic management without the SPSIP block.\n\nPostoperative pain intensity will be evaluated using the Numerical Rating Scale (NRS). Postoperative opioid requirements will also be recorded. In addition, postoperative recovery will be assessed using the Quality of Recovery-15T (QoR-15T) questionnaire. Patients will be followed during the postoperative period, including assessments at predefined time points up to 48 hours after surgery.\n\nThe primary objective of the study is to determine whether bilateral SPSIP block improves postoperative recovery and provides effective postoperative analgesia in patients undergoing cardiac surgery. Secondary evaluations will include postoperative pain scores and opioid consumption.",[58,64],{"label":59,"type":60,"description":61,"interventionNames":62},"SPSIP Block Group","ACTIVE_COMPARATOR","Participants in this group will receive ultrasound-guided bilateral single-shot serratus posterior superior intercostal plane (SPSIP) block in addition to standard perioperative care.",[63],"Procedure: Serratus posterior superior intercostal plane block",{"label":65,"type":60,"description":66,"interventionNames":67},"Control Group","Participants in this group will receive standard perioperative care without SPSIP block.",[68],"Procedure: Standard Perioperative Care",[70,77],{"type":71,"name":72,"description":73,"armGroupLabels":74,"otherNames":75},"PROCEDURE","Serratus posterior superior intercostal plane block","After induction of general anesthesia, an ultrasound-guided bilateral serratus posterior superior intercostal plane (SPSIP) block will be performed at the level of the third rib. Under ultrasound guidance, the needle will be advanced to the fascial plane between the serratus posterior superior muscle and the intercostal muscles. After confirmation of appropriate needle-tip position, 20 mL of 0.25% bupivacaine will be administered on each side. The same procedure will then be performed on the contralateral side.",[59],[76],"SPSIP Block",{"type":71,"name":78,"description":79,"armGroupLabels":80,"otherNames":45},"Standard Perioperative Care","Participants in the control group will receive standard perioperative care without serratus posterior superior intercostal plane (SPSIP) block. The perioperative management and postoperative follow-up protocol will otherwise be the same as in the SPSIP block group.",[65],[82],{"name":83,"role":84,"phone":85,"phoneExt":45,"email":86},"BURAK ÇİLİNGİR, Resident Physician","CONTACT","+90 552 075 78 85","burakcilingirr@gmail.com",[88],{"facility":89,"status":45,"city":90,"state":45,"zip":91,"country":92,"countryCode":45,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"Adıyaman Training and Research Hospital","Adıyaman","02100","Turkey (Türkiye)",{"type":94,"coordinates":95},"Point",[96,97],38.27629,37.76441,{"lat":97,"lon":96},[100],{"name":101,"role":84,"phone":85,"phoneExt":45,"email":86},"Burak Çilingir, Resident Physician",{"type":103,"investigatorFullName":104,"investigatorTitle":105,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"SPONSOR_INVESTIGATOR","Burak Çilingir","Resident Physician","100653232","ultrasound-guided-serratus-posterior-superior-intercostal-plane-block-for-cardiac-surgery-100653232",false,"NCT07785323","Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Cardiac Surgery","The Effect of Ultrasound-Guided Bilateral Single-Shot Serratus Posterior Superior Intercostal Plane Block on Recovery After Cardiac Surgery","Inclusion Criteria:\n\n* Patients aged 18-80 years\n* Patients scheduled for elective cardiac surgery\n* American Society of Anesthesiologists (ASA) physical status III--IV\n* Patients who provide written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Patient refusal to participate in the study\n* Known allergy to local anesthetics\n* Infection at the site of block application\n* Coagulopathy or contraindication to regional anesthesia\n* Emergency surgery\n* Patients unable to communicate adequately or complete the study assessments","ALL","18 Years","80 Years",{"count":117,"type":118},50,"ESTIMATED","INTERVENTIONAL",[121],"NA","This prospective, randomized, controlled study aims to evaluate the effects of ultrasound-guided bilateral single-shot serratus posterior superior intercostal plane (SPSIP) block on postoperative recovery and pain management in patients undergoing cardiac surgery. A total of 50 adult patients will be randomized into two groups: an SPSIP block group and a control group. The investigators will assess postoperative pain, opioid consumption, and quality of recovery during the postoperative period.",[124,125,126],"Cardiac Surgery","Postoperative Pain","Postoperative Recovery After Cardiac Surgery",[128,76,129,130,131,132],"Serratus Posterior Superior Intercostal Plane Block","Quality of Recovery","QoR-15","QoR-15T","Postoperative Analgesia","NOT_YET_RECRUITING","2026-08-21",{"date":136,"type":137},"2026-08-25","ACTUAL",{"date":139,"type":118},"2026-08-20",{"date":141,"type":118},"2027-02-01",{"name":104,"class":6},1]