[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621422":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":46,"studyPopulation":36,"armGroups":47,"interventions":59,"overallOfficials":36,"centralContacts":69,"locations":79,"responsibleParty":93,"collaborators":36,"id":97,"slug":36,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":36,"eligibilityCriteria":102,"healthyVolunteers":98,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":36,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":120,"whyStopped":36,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Bursa City Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Postoperative 48-Hour PCA Opioid Consumption","Total amount of opioid delivered by the patient-controlled analgesia (PCA) device during the first 48 hours after surgery, recorded in milligrams (mg).","Postoperative 0-8, 8-16, 16-24, 24-48 intervals",[14,18,22,26,29,33],{"measure":15,"description":16,"timeFrame":17},"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","Postoperative 24th and 48th hours",{"measure":19,"description":20,"timeFrame":21},"Dynamic and static Numeric Rating Scale scores","Numeric Rating Scale (NRS) (0-10; 0= no pain, 10 = the most severe pain felt) pain scores at rest or movement at predefined postoperative hours","0, 2, 4, 8, 16, 24, and 48 hours postoperatively",{"measure":23,"description":24,"timeFrame":25},"Total rescue analgesic dose","Despite the use of patient-controlled analgesia (PCA), if the Numeric Rating Scale (NRS) score is ≥4 at any time point, 0.5 mg\u002Fkg intravenous meperidine will be administered as rescue analgesia.\n\nTotal amount of meperidin during the first 24 and 48 hours after surgery, recorded in milligrams (mg).","Postoperative 48 hours",{"measure":27,"description":28,"timeFrame":25},"Time of first request for rescue analgesia","Despite the use of patient-controlled analgesia (PCA), if the Numeric Rating Scale (NRS) score is ≥4 at any time point, 0.5 mg\u002Fkg intravenous meperidine will be administered as rescue analgesia.",{"measure":30,"description":31,"timeFrame":32},"Length of Hospital Stay","Length of hospital stay will be defined as the number of days from the end of surgery to hospital discharge","Patients will remain under observation for at least 2 weeks until their postoperative discharge. Follow-up will be completed upon discharge. The length of hospital stay will be recorded.",{"measure":34,"description":35,"timeFrame":25},"Block and Opioid-Related Adverse Effects and Complications","Block- and opioid-related adverse effects and complications, including but not limited to local anesthetic toxicity, hematoma, infection, nerve injury, nausea, vomiting, pruritus, sedation, and respiratory depression, will be recorded",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":36,"primaryPurpose":40,"observationalModel":36,"timePerspective":36,"maskingInfo":41},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":42,"maskingDescription":36,"whoMasked":43},"DOUBLE",[44,45],"INVESTIGATOR","OUTCOMES_ASSESSOR","Lumbar instrumentation surgery is commonly associated with moderate-to-severe postoperative pain due to extensive tissue dissection and prolonged muscle retraction. Inadequate pain control may lead to delayed mobilization, increased cardiopulmonary complications, and prolonged hospital stay.\n\nUltrasound-guided regional analgesia techniques, particularly fascial plane blocks, are increasingly used as part of multimodal analgesia in lumbar spine surgery. The thoracolumbar interfascial plane (TLIP) block is an established technique that provides effective analgesia and has been modified to improve its clinical application, resulting in the modified thoracolumbar interfascial plane (mTLIP) block. Previous studies have demonstrated the effectiveness of mTLIP for postoperative analgesia after lumbar instrumentation surgery.\n\nThe quadro-iliac plane block (QIPB) is a recently described ultrasound-guided fascial plane block. Early reports suggest that QIPB may provide effective analgesia in lumbar spine procedures; however, comparative evidence with established techniques remains limited.\n\nThis prospective randomized controlled trial aims to compare bilateral ultrasound-guided mTLIP and QIPB performed at the end of surgery in patients undergoing elective lumbar instrumentation surgery under general anesthesia, to evaluate whether QIPB can be considered a safe and effective alternative to mTLIP for postoperative analgesia.",[48,54],{"label":49,"type":50,"description":51,"interventionNames":52},"Modified Thoracolumbar Interfascial Plane Block (mTLIP) Group","EXPERIMENTAL","Participants in this group will receive a bilateral ultrasound-guided modified thoracolumbar interfascial plane block (mTLIP) performed at the end of lumbar instrumentation surgery while in the prone position. Under sterile conditions, the ultrasound probe will be placed in the parasagittal plane at the midpoint of the surgical incision, taking into account the operated lumbar levels. The paraspinal muscles will be identified, and using an in-plane technique, the needle will be advanced into the interfascial plane between the longissimus and iliocostalis muscles. After confirmation of correct needle placement with saline, 20 mL of 0.25% bupivacaine will be injected on each side. The block will be performed bilaterally, with a total volume of 40 mL of 0.25% bupivacaine.",[53],"Procedure: Modified Thoracolumbar Interfascial Plane Block (mTLIP)",{"label":55,"type":50,"description":56,"interventionNames":57},"Quadro-Iliac Plane Block (QIPB) Group","Participants in this group will receive a bilateral ultrasound-guided quadro-iliac plane block (QIPB) performed at the end of lumbar instrumentation surgery while in the prone position. Under sterile conditions, a convex ultrasound probe will be placed at the point where the quadratus lumborum muscle attaches to the iliac crest. The erector spinae and quadratus lumborum muscles will be identified, and correct needle placement will be confirmed with saline injection. Subsequently, 20 mL of 0.25% bupivacaine will be injected on each side, with visualization of local anesthetic spread between the erector spinae and quadratus lumborum muscles. The block will be performed bilaterally, with a total volume of 40 mL of 0.25% bupivacaine.",[58],"Procedure: Quadro-Iliac Plane Block (QIPB):",[60,65],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":36},"PROCEDURE","Modified Thoracolumbar Interfascial Plane Block (mTLIP)","An ultrasound-guided bilateral fascial plane block in which local anesthetic is injected into the interfascial plane between the longissimus and iliocostalis muscles at the operated lumbar levels. The block is performed under sterile conditions at the end of surgery using 0.25% bupivacaine (20 mL per side; total volume 40 mL).",[49],{"type":61,"name":66,"description":67,"armGroupLabels":68,"otherNames":36},"Quadro-Iliac Plane Block (QIPB):","An ultrasound-guided bilateral fascial plane block in which local anesthetic is injected at the point where the quadratus lumborum muscle attaches to the iliac crest, allowing spread between the erector spinae and quadratus lumborum muscles. The block is performed under sterile conditions at the end of surgery using 0.25% bupivacaine (20 mL per side; total volume 40 mL).",[55],[70,75],{"name":71,"role":72,"phone":73,"phoneExt":36,"email":74},"Merih Yildiz Eglen, MD","CONTACT","+905059340629","meriheg@yahoo.com",{"name":76,"role":72,"phone":77,"phoneExt":36,"email":78},"Mursel Ekinci, Assoc prof MD","+905067137596","drmurselekinci@gmail.com",[80],{"facility":5,"status":36,"city":81,"state":82,"zip":83,"country":84,"countryCode":36,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"Nilufer","Bursa","16110","Turkey (Türkiye)",{"type":86,"coordinates":87},"Point",[88,89],28.91567,40.21401,{"lat":89,"lon":88},[92],{"name":71,"role":72,"phone":73,"phoneExt":36,"email":74},{"type":94,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"PRINCIPAL_INVESTIGATOR","Merih Yıldız Eglen","principal investigator, MD","100621422",false,"NCT07370415","mTLIP vs QIPB for Postoperative Analgesia After Lumbar Instrumentation Surgery","Comparison of Ultrasound-Guided Modified Thoracolumbar Interfascial Plane Block Versus Quadro-Iliac Plane Block for Postoperative Analgesia After Lumbar Instrumentation Surgery","Inclusion Criteria:\n\n* Age between 18 and 65 years\n* Classified as American Society of Anesthesiologists physical status I-III\n* Scheduled for elective lumbar instrumentation surgery under general anesthesia\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Use of anticoagulant medications or presence of bleeding diathesis\n* Known allergy or hypersensitivity to local anesthetics or opioid drugs\n* Infection at the planned block site\n* Alcohol or drug dependence\n* Cognitive impairment preventing reliable pain assessment\n* Pregnancy or lactation\n* History of previous lumbar spine surgery\n* Diabetes mellitus\n* Renal or hepatic insufficiency","ALL","18 Years","65 Years",{"count":107,"type":108},80,"ESTIMATED","INTERVENTIONAL",[111],"NA","Lumbar instrumentation surgery is associated with severe postoperative pain due to extensive tissue dissection and prolonged muscle retraction during the procedure. Inadequate postoperative pain control may result in delayed mobilization, increased cardiopulmonary complications, and prolonged hospital stay. Ultrasound-guided regional analgesia techniques are increasingly used to improve postoperative pain management after lumbar spine surgery. The thoracolumbar interfascial plane (TLIP) block has been shown to provide effective analgesia for lumbar instrumentation surgery, and its modified technique (mTLIP) has been reported to enhance postoperative pain control. The quadro-iliac plane (QIP) block is a newly described fascial plane block with promising results in lumbar spine surgery. This randomized controlled trial aims to compare the postoperative analgesic effectiveness of the modified thoracolumbar interfascial plane block and the quadro-iliac plane block in patients undergoing lumbar instrumentation surgery.",[114],"Pain, Postoperative",[116,117,118,119],"Lumbar instrumentation surgery","Postoperative Pain","Modified thoracolumbar interfascial plane block","Quadro-iliac plane block","NOT_YET_RECRUITING","2026-03-05",{"date":123,"type":124},"2026-03-06","ACTUAL",{"date":126,"type":108},"2026-03-20",{"date":128,"type":108},"2026-09-30",{"name":5,"class":6},1]