[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654358":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":47,"studyPopulation":36,"armGroups":48,"interventions":62,"overallOfficials":83,"centralContacts":91,"locations":97,"responsibleParty":114,"collaborators":36,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":36,"eligibilityCriteria":122,"healthyVolunteers":118,"sex":123,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":36,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":137,"overallStatus":143,"whyStopped":36,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Sheikh Zayed Medical College","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Postoperative pain intensity at 12 hours","Pain intensity measured using the Numerical Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain) assessed by an independent blinded outcome assessor.","12 hours after completion of surgery",[14,18,21,25,29,32],{"measure":15,"description":16,"timeFrame":17},"Postoperative pain intensity at 6 hours","Pain intensity measured using the Numerical Rating Scale (NRS 0-10) by an independent blinded outcome assessor.","6 hours after completion of surgery",{"measure":19,"description":16,"timeFrame":20},"Postoperative pain intensity at 24 hours","24 hours after completion of surgery",{"measure":22,"description":23,"timeFrame":24},"Time to first rescue analgesia","Time (in minutes or hours) from completion of surgery to the first administration of rescue analgesia for NRS score ≥4.","From completion of surgery up to 24 hours postoperatively",{"measure":26,"description":27,"timeFrame":28},"Proportion of participants requiring rescue analgesia within 24 hours","Percentage of participants who receive at least one dose of rescue analgesia (for NRS ≥4) within the first 24 postoperative hours.","First 24 hours after surgery",{"measure":30,"description":31,"timeFrame":28},"Total opioid\u002Frescue analgesic consumption within 24 hours","Cumulative dose of opioid or rescue analgesic administered within the first 24 postoperative hours, recorded from the medication administration record.",{"measure":33,"description":34,"timeFrame":35},"Incidence of block-related complications","Any complication considered related to QLB or TAP block (e.g., local anesthetic systemic toxicity, hematoma, infection, nerve injury, block failure).","During block performance and within 24 hours after the block",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":36,"primaryPurpose":40,"observationalModel":36,"timePerspective":36,"maskingInfo":41},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":42,"maskingDescription":43,"whoMasked":44},"DOUBLE","Patients will remain blinded to group allocation because both blocks are performed after induction of general anesthesia. The anesthesiologist administering the block cannot be blinded. Postoperative pain assessment and outcome recording will be performed by an independent outcome assessor who remains blinded to group allocation.",[45,46],"PARTICIPANT","OUTCOMES_ASSESSOR","Midline laparotomy is associated with significant postoperative pain that can limit mobilization, impair respiratory function, and increase opioid-related side effects. Abdominal wall blocks such as the transversus abdominis plane (TAP) block and quadratus lumborum block (QLB) are used as part of multimodal analgesia. TAP primarily targets somatic afferents of the anterior abdominal wall, while QLB may provide broader coverage including potential paravertebral spread via the thoracolumbar fascia, potentially offering longer-lasting analgesia.\n\nThis single-center, prospective, randomized controlled trial will enroll 100 adults (50 per group) aged 18-65 years, ASA physical status I-III, scheduled for elective midline laparotomy under general anesthesia. Participants will be randomized 1:1 using sequentially numbered, opaque, sealed envelopes prepared by an independent research assistant. Both blocks will be performed after induction of general anesthesia and before surgical incision by an experienced anesthesiologist under ultrasound guidance and strict aseptic precautions.\n\nGroup A (QLB): Bilateral lateral quadratus lumborum (QL1) block with 20 mL of 0.25% bupivacaine per side (total 40 mL \u002F 100 mg, not exceeding 2 mg\u002Fkg).\n\nGroup B (TAP): Bilateral TAP block with 20 mL of 0.25% bupivacaine per side (total 40 mL \u002F 100 mg, not exceeding 2 mg\u002Fkg).\n\nPostoperative analgesia will be standardized with intravenous paracetamol 1 g every 6 hours. Pain will be assessed using the Numerical Rating Scale (NRS 0-10) at 6, 12, and 24 hours by an independent, blinded outcome assessor. Rescue analgesia (intravenous morphine or tramadol) will be given for NRS ≥4. Primary and secondary analgesic outcomes include NRS scores, time to first rescue analgesia, proportion requiring rescue analgesia within 24 hours, and total opioid consumption in the first 24 hours. Block-related complications will also be recorded.\n\nStatistical analysis will use SPSS version 26. Normality will be assessed by Shapiro-Wilk test. Continuous variables will be compared with independent-samples t-test or Mann-Whitney U test; categorical variables with Chi-square or Fisher's exact test. Potential confounders will be addressed by stratification. A two-sided p-value ≤0.05 will be considered statistically significant.",[49,56],{"label":50,"type":51,"description":52,"interventionNames":53},"Group A: Quadratus Lumborum Block (QLB)","EXPERIMENTAL","Participants receive bilateral ultrasound-guided lateral quadratus lumborum (QL1) block after induction of general anesthesia and before surgical incision. 20 mL of 0.25% bupivacaine is injected on each side (total 40 mL \u002F 100 mg, dose not exceeding 2 mg\u002Fkg).",[54,55],"Procedure: Ultrasound-Guided Lateral Quadratus Lumborum Block (QL1)","Drug: Bupivacaine 0.25%",{"label":57,"type":58,"description":59,"interventionNames":60},"Group B: Transversus Abdominis Plane Block (TAPB)","ACTIVE_COMPARATOR","Participants receive bilateral ultrasound-guided transversus abdominis plane block after induction of general anesthesia and before surgical incision. 20 mL of 0.25% bupivacaine is injected on each side (total 40 mL \u002F 100 mg, dose not exceeding 2 mg\u002Fkg).",[61,55],"Procedure: Ultrasound-Guided Transversus Abdominis Plane Block",[63,71,78],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":68},"PROCEDURE","Ultrasound-Guided Lateral Quadratus Lumborum Block (QL1)","After induction of general anesthesia and before surgical incision, under strict aseptic precautions, a low-frequency curvilinear ultrasound transducer is placed between the costal margin and iliac crest. An echogenic 22-gauge 80-100 mm block needle is advanced in-plane toward the anterolateral border of the quadratus lumborum muscle near the junction of the transversus abdominis aponeurosis and transversalis fascia. After hydrodissection and negative aspiration, 20 mL of 0.25% bupivacaine is injected on each side under continuous ultrasound visualization of local anesthetic spread. Total planned volume 40 mL (100 mg bupivacaine), not exceeding 2 mg\u002Fkg.",[50],[69,70],"QLB","QL1 Block",{"type":64,"name":72,"description":73,"armGroupLabels":74,"otherNames":75},"Ultrasound-Guided Transversus Abdominis Plane Block","After induction of general anesthesia and before surgical incision, under strict aseptic precautions, a high-frequency linear ultrasound transducer is placed transversely on the anterolateral abdominal wall between the costal margin and iliac crest. The external oblique, internal oblique, and transversus abdominis muscles are identified. An echogenic 22-gauge block needle is advanced in-plane until the tip lies in the fascial plane between the internal oblique and transversus abdominis muscles. After hydrodissection and negative aspiration, 20 mL of 0.25% bupivacaine is injected on each side under continuous ultrasound visualization of local anesthetic spread. Total planned volume 40 mL (100 mg bupivacaine), not exceeding 2 mg\u002Fkg.",[57],[76,77],"TAP Block","TAPB",{"type":79,"name":80,"description":81,"armGroupLabels":82,"otherNames":36},"DRUG","Bupivacaine 0.25%","Local anesthetic used for both QLB and TAP blocks: 20 mL of 0.25% bupivacaine per side (total 40 mL \u002F 100 mg), dose adjusted not to exceed 2 mg\u002Fkg body weight.",[50,57],[84,88],{"name":85,"affiliation":86,"role":87},"Kiran Azhar, MBBS, FCPS-II (Anesthesia) PGR","Department of Anesthesiology & ICU, Sheikh Zayed Medical College\u002FHospital, Rahim Yar Khan","PRINCIPAL_INVESTIGATOR",{"name":89,"affiliation":86,"role":90},"Sairah Sadaf, FCPS","STUDY_CHAIR",[92],{"name":93,"role":94,"phone":95,"phoneExt":36,"email":96},"Kiran Azhar, MBBS","CONTACT","03216220839","azharkiran136@gmail.com",[98],{"facility":99,"status":36,"city":100,"state":101,"zip":36,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":109,"contacts":110},"Sheikh Zayed Medical College\u002FHospital","Rahim Yar Khan","Punjab Province","Pakistan","PK",{"type":105,"coordinates":106},"Point",[107,108],70.30345,28.41987,{"lat":108,"lon":107},[111,113],{"name":112,"role":94,"phone":95,"phoneExt":36,"email":96},"Kiran Azhar",{"name":85,"role":87,"phone":36,"phoneExt":36,"email":36},{"type":87,"investigatorFullName":112,"investigatorTitle":115,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Post-graduate Resident (FCPS-II Anesthesia)","100654358","analgesic-outcomes-of-ultrasound-guided-qlb-vs-tap-block-in-midline-laparotomy-100654358",false,"NCT07796828","Analgesic Outcomes of Ultrasound-Guided QLB vs TAP Block in Midline Laparotomy","Analgesic Outcomes of Ultrasound Guided Quadratus Lumborum Block Compared With Transversus Abdominis Plane Block in Patients Undergoing Midline Laparotomy","Inclusion Criteria:\n\n* Age 18-65 years\n* Either sex\n* Scheduled for elective midline laparotomy (upper, lower, or full midline incision) under general anesthesia\n* ASA physical status I-III\n\nExclusion Criteria:\n\n* Body mass index \\>40 kg\u002Fm²\n* Existing chronic pain disorder, established opioid dependence, or history of substance abuse\n* Previous or current neurological or psychiatric illness likely to compromise comprehension, decision-making capacity, or reliable reporting of pain scores\n* Conditions in which an abdominal wall block would not be appropriate or safe (bleeding tendency, ongoing anticoagulation outside acceptable limits, local skin or soft-tissue infection at the planned puncture site, or major distortion of abdominal wall anatomy)\n* Urgent laparotomy performed for peritonitis or unstable physiology (including patients requiring continuous vasopressor support)\n* Previous abdominal wall surgery, large incisional hernia, or distorted flank\u002Fanterior abdominal wall anatomy likely to impair standardized block placement","ALL","18 Years","65 Years",{"count":127,"type":128},100,"ESTIMATED","INTERVENTIONAL",[131],"NA","This randomized controlled trial compares the analgesic efficacy of ultrasound-guided bilateral lateral quadratus lumborum block (QLB, QL1) versus ultrasound-guided bilateral transversus abdominis plane (TAP) block in adults undergoing elective midline laparotomy under general anesthesia. The primary focus is postoperative pain intensity, time to first rescue analgesia, proportion requiring rescue analgesia, and total opioid consumption in the first 24 hours.",[134,135,136],"Postoperative Pain","Midline Laparotomy","Abdominal Surgery",[138,139,140,141,135,142],"Quadratus Lumborum Block","Transversus Abdominis Plane Block","Ultrasound-Guided Regional Anesthesia","Postoperative Analgesia","Multimodal Analgesia","NOT_YET_RECRUITING","2026-08-27",{"date":146,"type":147},"2026-09-01","ACTUAL",{"date":149,"type":128},"2026-09",{"date":151,"type":128},"2027-03",{"name":5,"class":6},1]