[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653625":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":57,"studyPopulation":48,"armGroups":58,"interventions":69,"overallOfficials":48,"centralContacts":74,"locations":48,"responsibleParty":80,"collaborators":48,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":48,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":48,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":104,"overallStatus":109,"whyStopped":48,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":48},{"fullName":5,"class":6},"Antalya City Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":48},[9],{"measure":10,"description":11,"timeFrame":12},"Postoperative pain scores","Postoperative pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores at rest will be recorded in the post-anesthesia care unit and at postoperative 6, 24, 36, and 48 hours. Pain scores during movement will be assessed during passive flexion of the operated hip at postoperative 6, 24, 36, and 48 hours.","6,24,36,48 hours",[14,18,22,26,30,33,37,41,45],{"measure":15,"description":16,"timeFrame":17},"Postoperative opioid consumption","Total postoperative opioid consumption will be recorded and cumulative opioid consumption will be calculated at postoperative 24 and 48 hours.","postoperative 24 and 48 hours",{"measure":19,"description":20,"timeFrame":21},"Incidence of quadriceps motor block","Quadriceps motor block will be assessed using knee extension testing and graded as:\n\n0 = normal strength\n\n1. = paresis\n2. = paralysis. Motor block incidence will be defined as the presence of paresis or paralysis.","Postoperative 3, 6, and 24 hours",{"measure":23,"description":24,"timeFrame":25},"Time to first ambulation","Time from the end of surgery to the first successful ambulation.","Postoperative day 1",{"measure":27,"description":28,"timeFrame":29},"Patient satisfaction","Patient satisfaction with postoperative analgesia will be assessed using a Likert scale.","Postoperative 48 hours",{"measure":31,"description":32,"timeFrame":29},"Postoperative nausea and vomiting (PONV)","Incidence of postoperative nausea and vomiting during the first 48 postoperative hours.",{"measure":34,"description":35,"timeFrame":36},"Block performance time","Time from ultrasound probe placement to completion of local anesthetic injection.","Periprocedural",{"measure":38,"description":39,"timeFrame":40},"Falls","Incidence of falls during the first 48 postoperative hours.","Through postoperative day 2",{"measure":42,"description":43,"timeFrame":44},"Length of hospital stay","Number of days from surgery to hospital discharge.","Through hospital discharge, up to 30 days",{"measure":46,"description":47,"timeFrame":44},"Block-related complications","Hematoma Vascular puncture Local anesthetic systemic toxicity (LAST) Infection at the injection site",null,{"allocation":50,"interventionModel":51,"interventionModelDescription":48,"primaryPurpose":52,"observationalModel":48,"timePerspective":48,"maskingInfo":53},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":54,"maskingDescription":48,"whoMasked":55},"SINGLE",[56],"PARTICIPANT","Materials and Methods:\n\nThis prospective, randomized clinical trial will include patients aged 18-80 years with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled to undergo elective primary lumbar stabilization surgery under general anesthesia. Before enrollment, all patients will be informed about the study protocol and written informed consent will be obtained. Patients will be instructed on the use of the Numeric Rating Scale (NRS) for postoperative pain assessment, where 0 represents no pain and 10 represents the worst pain imaginable.\n\nPatients with contraindications to regional anesthesia, allergy to local anesthetics, coagulopathy, infection at the injection site, chronic opioid use, pre-existing neurological deficits involving the lower extremities, cognitive impairment preventing reliable communication, revision lumbar surgery, and refusal to participate will be excluded from the study.\n\nPatients will be randomly allocated to one of two study groups using a computer-generated randomization sequence (https:\u002F\u002Fwww.randomizer.org). Randomization will be performed by a team member not involved in patient management or outcome assessment. Allocation concealment will be achieved using sequentially numbered sealed opaque envelopes, which will be opened immediately before block performance.\n\nUpon arrival in the operating room, standard monitoring including electrocardiography, non-invasive blood pressure measurement, and pulse oximetry will be applied. Following intravenous access, general anesthesia will be induced using a standardized protocol consisting of propofol, fentanyl, and rocuronium to facilitate endotracheal intubation. Anesthesia will be maintained with sevoflurane or desflurane in an oxygen\u002Fair mixture, titrated to maintain hemodynamic stability within 20% of baseline values.\n\nFollowing the induction of general anesthesia and prior to surgical incision, patients will receive either ultrasound-guided quadro-iliac plane block (QIPB) or ultrasound-guided erector spinae plane block (ESPB) according to group allocation. All blocks will be performed by anesthesiologists experienced in regional anesthesia and familiar with both techniques.\n\nAll patients will receive the same multimodal postoperative analgesic regimen and standardized postoperative rehabilitation protocol. Postoperative pain scores at rest and during movement will be assessed using the NRS during the first 48 postoperative hours. Opioid consumption, incidence of quadriceps motor block, time to first ambulation, patient satisfaction, postoperative nausea and vomiting, falls, length of hospital stay, block performance time, and block-related complications will also be recorded.\n\nOutcome assessments will be performed by investigators who are unaware of group allocation.",[59,65],{"label":60,"type":61,"description":62,"interventionNames":63},"quadro-iliac plane block (QIPB)","ACTIVE_COMPARATOR","Participants allocated to the QIPB group will receive an ultrasound-guided quadro-iliac plane block after the induction of general anesthesia. Following standard aseptic preparation, 30 mL of 0.25% bupivacaine will be administered into the target fascial plane under ultrasound guidance after confirming the absence of blood on aspiration.",[64],"Procedure: Quadro iliac Plane Block",{"label":66,"type":61,"description":67,"interventionNames":68},"Erector Spina Plane Block","Participants in the ESPB group will undergo an ultrasound-guided erector spinae plane block after the induction of general anesthesia. A total of 20 mL of 0.25% bupivacaine will be administered into the target fascial plane under ultrasound guidance after confirming the absence of blood on aspiration.",[64],[70],{"type":71,"name":72,"description":62,"armGroupLabels":73,"otherNames":48},"PROCEDURE","Quadro iliac Plane Block",[66,60],[75],{"name":76,"role":77,"phone":78,"phoneExt":48,"email":79},"Damla Kaytancı Özçelik, MD","CONTACT","+905075124445","damla.kaytanci@saglik.gov.tr",{"type":81,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR","100653625","esp-block-vs-qipb-for-lumbar-stabilization-surgery-100653625",false,"NCT07789509","ESP Block Vs. QIPB for Lumbar Stabilization Surgery","Comparison Between Quadro-iliac Plane Block (QIPB) and Erector Spinae Plane (ESP) Block for Lumbar Stabilization Surgery: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Age between 18 and 80 years\n* American Society of Anesthesiologists physical status I-III\n* Scheduled for elective primary lumbar stabilization surgery\n* Surgery planned under general anesthesia\n* Ability to understand and use the Numeric Rating Scale\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Refusal to participate\n* Revision lumbar stabilization surgery\n* Contraindication to regional anesthesia\n* Contraindication to peripheral nerve\u002Fplane block\n* Known allergy to local anesthetics or study drugs\n* Coagulopathy or anticoagulant use incompatible with neuraxial\u002Fregional -anesthesia\n* Infection at the block injection site\n* Pre-existing neurological deficit involving the lower extremities (unrelated to t-he current spinal pathology)\n* Peripheral neuropathy\n* Chronic opioid use\n* Cognitive impairment or inability to communicate reliably\n* Severe hepatic or renal failure\n* Body mass index \\> 35 kg\u002Fm2\n* Pregnancy","ALL","18 Years","80 Years",{"count":93,"type":94},60,"ESTIMATED","INTERVENTIONAL",[97],"NA","This randomized clinical trial aims to evaluate and compare the analgesic efficacy and functional outcomes of the quadro-iliac plane block (QIPB) and the erector spinae plane block (ESPB) in patients undergoing lumbar stabilization surgery. The primary outcome is the Numeric Rating Scale (NRS) within the first 48 hours after surgery. Secondary outcomes include postoperative total opioid consumption, incidence of quadriceps motor block, time to first ambulation, block performance time, falls, length of hospital stay, block-related complications (hematoma, local anesthetic systemic complications, vascular puncture, and infection), patient satisfaction assessed using a Likert scale, and incidence of postoperative nausea and vomiting.",[100,101,102,103],"Quadro-Iliac Plane Block","Erector Spina Plan Block","Lumbar Stabilization Surgery","Pain Management",[105,106,107,108],"QIPB","ESP","Lumbar","Analgesia","NOT_YET_RECRUITING","2026-08-24",{"date":112,"type":113},"2026-08-27","ACTUAL",{"date":115,"type":94},"2026-11-15",{"date":117,"type":94},"2027-09-15",{"name":5,"class":6}]