[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614088":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":40,"studyPopulation":30,"armGroups":41,"interventions":53,"overallOfficials":30,"centralContacts":67,"locations":77,"responsibleParty":93,"collaborators":30,"id":97,"slug":30,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":30,"eligibilityCriteria":102,"healthyVolunteers":98,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":30,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":79,"whyStopped":30,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Bursa City Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Postoperative 24-Hour PCA Opioid Consumption","Total amount of opioid delivered by the patient-controlled analgesia (PCA) device during the first 24 hours after surgery, recorded in milligrams (mg).","Postoperative 24 hours",[14,18,22,26],{"measure":15,"description":16,"timeFrame":17},"NRS Pain Scores at Rest and Movement","Numeric Rating Scale (NRS) (0-10) pain scores at rest and during movement or coughing at predefined postoperative hours.","2, 4, 8, 16, 24, and 48 hours postoperatively",{"measure":19,"description":20,"timeFrame":21},"QoR-15 Recovery Score","The investigators will use the Turkish version of Quality of Recovery (QoR) \u002F QoR-15 questionairre\n\nPART A How have you been feeling in the last 24 hours? (0 to 10, where: 0 = none of the time \\[poor\\] and 10 = all of the time \\[excellent\\])\n\nAble to breathe easily Been able to enjoy food Feeling rested Have had a good sleep Able to look after personal toilet and hygiene unaided Able to communicate with Getting support from hospital doctors and nurses Able to return to work or usual home activities Feeling comfortable and in control Having a feeling of general well-being\n\nPART B Have you had any of the following in the last 24 hours? (10 to 0, where: 10 = none of the time \\[excellent\\] and 0 = all of the time \\[poor\\]) Moderate pain Severe pain Nausea or vomiting Feeling worried or anxious Feeling sad or depressed","The quality of recovery will be evaluated out of a total of 150 points according to the QoR-15 test to be applied at the portoperative 24th hour.]",{"measure":23,"description":24,"timeFrame":25},"Chronic Pain Assessment","Pain status using the Brief Pain Inventory (BPI) via telephone follow-up.\n\nGeneral Scoring: The BPI comprises the Pain Severity and Pain Interference subscales. Each item is scored on a 0 (None\u002FNo interference) to 10 (Worst imaginable\u002FCompletely disabling) numerical scale. Higher scores indicate a worse clinical outcome. Subscale scores are calculated by taking the arithmetic mean of relevant items.\n\n1. Pain Severity Subscale (4 Items): Assesses pain intensity over the last 24 hours. (0-10) What is your pain level right now What was your pain at its least in the last 24 hours What was your pain at its worst in the last 24 hours What was your pain on average in the last 24 hours\n2. Pain Interference Subscale (7 Items): Assesses the degree to which pain interferes with daily functioning Questions: The patient rates how much pain interfered with: (0-10) General activity Mood Walking ability Normal work Relations with people Sleep Enjoyment of life","3 months postoperatively",{"measure":27,"description":28,"timeFrame":29},"Rescue Analgesic Requirement","Number of patients requiring rescue analgesia (IV meperidine 0.5 mg\u002Fkg) and total dose administered when NRS ≥ 4.","Postoperative 0-48 hours",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":36,"maskingDescription":30,"whoMasked":37},"DOUBLE",[38,39],"INVESTIGATOR","OUTCOMES_ASSESSOR","Thoracotomy often causes strong postoperative pain because the ribs, muscles, nerves, and pleura are affected during surgery. This pain can make it difficult for patients to breathe well and may increase the chance of lung problems. Paravertebral block is a well-known method for reducing pain after thoracic surgery, but it can sometimes lead to side effects such as low blood pressure or complications related to deeper needle placement.\n\nThe serratus posterior superior intercostal plane block is a newer ultrasound-guided technique. In this method, local anesthetic is injected between the serratus posterior superior muscle and the intercostal muscles. Early studies suggest that it may provide wide pain relief, but its effectiveness specifically in thoracotomy patients has not yet been studied.\n\nThis randomized study aims to compare the pain-relieving effects of the serratus posterior superior intercostal plane block with those of the paravertebral block after thoracotomy. The goal is to find out whether this new block can be a safe and effective option for postoperative pain management.",[42,48],{"label":43,"type":44,"description":45,"interventionNames":46},"Group SPSIP","ACTIVE_COMPARATOR","Participants in this arm will receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane Block. The block will be performed preoperatively with the patient in the appropriate position. A local anesthetic solution will be injected between the serratus posterior superior muscle and the intercostal muscles under real-time ultrasound guidance. The technique aims to achieve postoperative analgesia by providing sensory blockade across targeted thoracic dermatomes. No additional regional block will be performed in this group.",[47],"Procedure: Serratus Posterior Superior Intercostal Plane Block",{"label":49,"type":44,"description":50,"interventionNames":51},"Group Paravertebral","Participants in this arm will receive an ultrasound-guided thoracic paravertebral block. The block will be performed preoperatively with the patient in the appropriate position. Under real-time ultrasound guidance, a local anesthetic solution will be injected into the thoracic paravertebral space at the planned level to achieve unilateral somatic and sympathetic nerve blockade. This intervention is intended to provide postoperative analgesia following thoracotomy. No additional regional block will be administered in this group.",[52],"Procedure: Thoracic Paravertebral Block",[54,61],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"PROCEDURE","Serratus Posterior Superior Intercostal Plane Block","Ultrasound-guided regional anesthesia technique performed between the serratus posterior superior muscle and intercostal muscles.",[43],[60],"SPSIP Block",{"type":55,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"Thoracic Paravertebral Block","Ultrasound-guided injection of local anesthetic into the thoracic paravertebral space to provide unilateral analgesia.",[49],[66],"Paravertebral Block",[68,73],{"name":69,"role":70,"phone":71,"phoneExt":30,"email":72},"Mursel Ekinci, Assoc prof,MD","CONTACT","+905067137596","drmurselekinci@gmail.com",{"name":74,"role":70,"phone":75,"phoneExt":30,"email":76},"Mustafa Dikici, MD","+905055346540","mus.dikici88@gmail.com",[78],{"facility":5,"status":79,"city":80,"state":30,"zip":81,"country":82,"countryCode":30,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"RECRUITING","Bursa","16110","Turkey (Türkiye)",{"type":84,"coordinates":85},"Point",[86,87],29.06013,40.19559,{"lat":87,"lon":86},[90,91],{"name":74,"role":70,"phone":75,"phoneExt":30,"email":76},{"name":30,"role":70,"phone":92,"phoneExt":30,"email":30},"+90224975 00 00",{"type":94,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Mursel Ekinci","Assoc Prof","100614088",false,"NCT07275047","Analgesic Efficacy of SPSIP Block Versus Paravertebral Block Following Thoracotomy","Comparison of Ultrasound Guided Serratus Posterior Superior Intercostal Plane Block Versus Paravertebral Block for Postoperative Analgesia After Thoracotomy","Inclusion Criteria:\n\n* Scheduled to undergo thoracotomy\n* ASA physical status I-III according to the American Society of Anesthesiologists classification\n* Able to understand the study procedures and provide written informed consent\n\nExclusion Criteria:\n\n* Declines or is unable to provide informed consent\n* Allergy or hypersensitivity to local anesthetics or opioids\n* Known or suspected coagulopathy\n* Infection at the injection site\n* History of thoracic surgery\n* Severe cardiovascular disease\n* Hepatic or renal failure\n* Pregnant, suspected pregnancy, or breastfeeding\n\nSignificant neurological or psychiatric disorder that may interfere with study participatio","ALL","18 Years","65 Years",{"count":107,"type":108},80,"ESTIMATED","INTERVENTIONAL",[111],"NA","Thoracotomy causes severe postoperative pain that may impair respiratory function and increase complications. This study compares the postoperative analgesic effectiveness of the serratus posterior superior intercostal plane (SPSIP) block and the paravertebral block in patients undergoing thoracotomy. The aim is to determine whether the newly described serratus posterior superior intercostal plane block can serve as a safe and effective alternative to established techniques.",[114],"Post-thoracotomy Pain",[116,117,66,118],"Post-thoracotomy pain","Serratus posterior superior intercostal plane block","Pain management","2025-12-22",{"date":121,"type":122},"2025-12-23","ACTUAL",{"date":124,"type":122},"2025-12-15",{"date":126,"type":108},"2026-12-15",{"name":5,"class":6},1]