[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658436":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":39,"studyPopulation":27,"armGroups":40,"interventions":53,"overallOfficials":27,"centralContacts":67,"locations":73,"responsibleParty":89,"collaborators":93,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":27,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":27,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":27,"overallStatus":120,"whyStopped":27,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Koc University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"Postoperative opioid consumption for 24 hours","The primary outcome is cumulative opioid consumption from the end of surgery through postoperative hour 24, expressed as IV morphine equivalents.\n\nPostoperative opioids will be converted to IV morphine equivalents using the ENCORE Study conversion table.\n\nThe following conversion factors will be used:\n\nIV fentanyl: dose in micrograms × 0.066 = IV morphine equivalents in mg. IV tramadol: dose in mg × 0.1 = IV morphine equivalents in mg.","postoperative 24 hours",[14,18,21,24],{"measure":15,"description":16,"timeFrame":17},"postoperative opioid consumption for 48 hours","Cumulative opioid consumption from the end of surgery through postoperative hour 48, expressed as IV morphine equivalents. Assesment will be made at postoperative 1,3,6,12,24 and 48th hour.\n\nPostoperative opioids will be converted to IV morphine equivalents using the ENCORE Study conversion table. The following conversion factors will be used: IV fentanyl: dose in micrograms × 0.066 = IV morphine equivalents in mg. IV tramadol: dose in mg × 0.1 = IV morphine equivalents in mg.","postoperative 48 hours",{"measure":19,"description":20,"timeFrame":17},"pain score","Pain will be assesed by NRS scores at rest and cough, expressed drom 0 to 10. Assesment will be made at postoperative 1,3,6,12,24 and 48th hour.",{"measure":22,"description":23,"timeFrame":17},"adverse effects","Incidence and details of nausea, vomiting, pruritus, allergic reaction, sedation, respiratory depression, urinary retention, LAST, bleeding or hematoma, infection, persistent sensory or motor deficit, nerve injury, visceral or renal injury, and any other opioid or block-related adverse event through 48 hours.",{"measure":25,"description":26,"timeFrame":17},"patient satisfaction","6\\. Patient satisfaction at 48 hours, assessed by asking: \"How satisfied were you with your postoperative pain management?\" The response will range from 0 to 10.",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":31,"primaryPurpose":32,"observationalModel":27,"timePerspective":27,"maskingInfo":33},"RANDOMIZED","PARALLEL","Eligible participants will be enrolled consecutively and allocated in a 1:1 ratio to TFPB or PQLB. The anesthesiologist performing the block will be aware of the treatment allocation but will have no other role in the study or in the patient management, follow-up, outcome assessment, data entry, or statistical analysis of the study. Same senior anesthesiologist that is experienced in both block technique will administer both blocks in the trial.","SUPPORTIVE_CARE",{"masking":34,"maskingDescription":35,"whoMasked":36},"DOUBLE","Manual envelope randomization will be used. An anesthesia technician who is independent of the trial will prepare the allocation envelopes before recruitment begins.The preparing technician will place one card into each identical,Participants, intraoperative and postoperative anesthesia personnel involved in clinical follow-up, the surgical team, pain-service personnel, and outcome assessors will remain blinded to treatment allocation.\n\nBlock-specific documentation and the restricted randomization log will be kept separately from the clinical follow-up file. The block anesthesiologist will not disclose the allocation and will not participate in any other role in the study or in the patient management, follow-up, outcome assessment, data entry, or statistical analysis of the study.",[37,38],"PARTICIPANT","OUTCOMES_ASSESSOR","Hand-assisted laparoscopic donor nephrectomy (HALDN) is a widely used technique for kidney donor surgeries. Management of postoperative pain is important to provide patient comfort. Main components of postoperative pain is from incision sides. Regional anesthesia techniques may reduce postoperative opioid requirements in this patient group, but the optimal block for this procedure has not been established.\n\nA competed but not yet published study in our clinic found that transversalis fascia plane block significantly reduced analgesic requirements after HALDN. Its a deep block, that involves injection below transversalis fascia and above perirenal fat tissue. Its location can be seen relatively close to the important structures of such as peritoneum and retroperitenoum. Posterior quadratus lumborum block (PQLB, also known as quadratus lumborum block -2 or QLB-2) is considered effective in renal surgery for other indications and PQLB may provide analgesia comparable to TFPB for HALDN surgery. Possible benefit of PQLB over TFPB is superficial anatomical location of PQLB and its relative distance to areas such as retroperitoneum and peritoneum. Results in our center shows TFPB effective in HALDN procedure, therefore it is selected as the control group intervention This trial is designed to determine whether PQLB is not inferior to TFPB for cumulative opioid consumption during the first 24 postoperative hours for HALDN surgery. Opioid consumption, pain scores and adverse effects through first 48 hours postoperatively and patient satisfaction at 48th hour will be evaluated as a secondary outcome to describe the duration of postoperative analgesic effect.\n\nRoutine preanesthetic premedication with midazolam 0.03 mg\u002Fkg will be administered to both study groups. Anesthesia will be induced with fentanyl 1-2 micrograms\u002Fkg IV, propofol 1-2 mg\u002Fkg IV, and rocuronium 0.9-1.2 mg\u002Fkg IV.\n\nGeneral anesthesia will be maintained with 40% inspired oxygen, desflurane at approximately 1 minimum alveolar concentration, and a remifentanil infusion at 0 - 0.02 micrograms\u002Fkg\u002Fmin. The actual doses of all intraoperative opioids will be recorded. Intraoperative fentanyl and remifentanil administered before the end of surgery will not be included in the primary outcome.\n\nThe assigned block will be performed after induction of general anesthesia and before surgical incision, with the participant in the lateral position and the operative side facing upward.\n\nStandard anesthesia monitoring will continue throughout block placement and until the surgery ends.\n\nAt the end of surgery, all participants will receive paracetamol 1 g IV and morphine 0.05 mg\u002Fkg IV in addition to regional anesthesia technique as standardized multimodal analgesia regiment. The end-of-surgery morphine dose will be included in cumulative postoperative opioid consumption.\n\nParticipants will be extubated in the operation room when clinically appropriate and transferred to the post-anesthesia care unit.\n\nIn the PACU, a morphine PCA device will be started using a 1 mg IV bolus, an 8-minute lockout interval, and no basal infusion. Device-generated records will be used to determine PCA consumption. In PACU, if NRS is greater than or equal to 4 is observed, fentanyl 50 micrograms IV will be administered up to three times at 15-minute intervals. All fentanyl administered in the PACU will be included in cumulative postoperative opioid consumption.\n\nFor 48 hours, all participants will receive paracetamol 1 g IV three times daily and morphine PCA using the same settings. In surgical ward, If NRS is greater than or equal to 4 is observed, tramadol 100 mg IV will be administered as rescue analgesia in accordance with institutional prescribing limits.\n\nEvery rescue dose and any additional analgesic treatment required for clinical care will be recorded. Tramadol will be converted to IV morphine equivalents and included in cumulative postoperative opioid consumption.\n\nMorphine PCA cumulative consumption, rescue opioid and analgesic use, NRS at rest, NRS during cough, and opioid-related and block-related adverse events will be assessed at postoperative hours 1, 3, 6, 12, 24, and 48.\n\nPatient satisfaction with postoperative pain management will be assessed at postoperative hour 48.\n\nProtocol deviations, withdrawal, loss to follow-up, unblinding, and missing assessments will be recorded whenever they occur.",[41,47],{"label":42,"type":43,"description":44,"interventionNames":45},"PQLB","EXPERIMENTAL","Posterior quadratus lumborum block will be administered by the senior anesthesiologist, following the anesthesia induction and before the surgical incision.",[46],"Procedure: Quadratus Lumborum Block type 2",{"label":48,"type":49,"description":50,"interventionNames":51},"TFPB","ACTIVE_COMPARATOR","Transversalis fascia plane block will be administered by the senior anesthesiologist, following the anesthesia induction and before the surgical incision.",[52],"Procedure: Transversalis Fascia Plane Block",[54,62],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"PROCEDURE","Quadratus Lumborum Block type 2","Posterior Quadratus Lumborum Block Technique A 2-6 MHz convex ultrasound probe will be positioned parallel to and over the iliac crest. Anterior and posterior scanning will identify the quadratus lumborum, psoas major, transversus abdominis, external and internal oblique muscles, lumbar vertebral body and transverse process, and perirenal adipose tissue.\n\nAn 80-mm Stimuplex needle will be advanced in-plane under continuous ultrasound visualization. After negative aspiration, 30 mL of 0.25% bupivacaine will be injected into the posterior fascial plane of the quadratus lumborum muscle.\n\nSpread of the solution will be observed continuously using ultrasound, with repeated aspiration during injection.",[42],[60,42,61],"QLB-2","Posterior quadratus lumborum block",{"type":55,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"Transversalis Fascia Plane Block","Transversalis fascia plane block administration technique: A 2-6 MHz convex ultrasound probe will be positioned parallel to and over the iliac crest. Anterior and posterior scanning will identify the quadratus lumborum, psoas major, transversus abdominis, external and internal oblique muscles, lumbar vertebral body and transverse process, and perirenal adipose tissue.\n\nAn 80-mm Stimuplex needle will be advanced in-plane under continuous ultrasound visualization. After negative aspiration, 30 mL of 0.25% bupivacaine will be injected over the perirenal adipose tissue beneath the transversus abdominis fascia.\n\nSpread of the solution will be observed continuously using ultrasound, with repeated aspiration during injection to reduce the risk of intravascular administration.",[48],[48],[68],{"name":69,"role":70,"phone":71,"phoneExt":27,"email":72},"Eren Y AÇIKALIN, MD","CONTACT","+90 533 747 21 48","erenyacikalin@gmail.com",[74],{"facility":75,"status":27,"city":76,"state":77,"zip":78,"country":79,"countryCode":27,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"Koç University Hospital","Istanbul","Zeytinburnu","34010","Turkey (Türkiye)",{"type":81,"coordinates":82},"Point",[83,84],28.94966,41.01384,{"lat":84,"lon":83},[87],{"name":88,"role":70,"phone":71,"phoneExt":27,"email":72},"Eren Yavuz AÇIKALIN",{"type":90,"investigatorFullName":88,"investigatorTitle":91,"investigatorAffiliation":92,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Principal investigator","Koç University",[94],{"name":95,"class":96},"Koç University School of Medicine","UNKNOWN","100658436","pqlb-vs-tfpb-in-haldn-100658436",false,"NCT07852663","PQLB vs TFPB in HALDN","Effect of Posterior Quadratus Lumborum Block and Transversalis Fascia Plane Block on Opioid Consumption in Hand-Assisted Laparoscopic Donor Nephrectomy: A Randomized, Double-Blind, Non-Inferiority Trial","Inclusion Criteria:\n\n* Approved and scheduled for hand-assisted laparoscopic donor nephrectomy.\n* Aged 18-84 years.\n* Classified as ASA physical status I-II.\n* Able to provide written informed consent.\n* Written informed consent obtained before any study-specific procedure.\n\nExclusion Criteria:\n\n* Allergy to any study medication.\n* Chronic use of opioids or opioid-receptor agonists.\n* History of psychiatric illness\n* Chronic organ failure.\n* Inability to communicate sufficiently for informed consent or outcome assessment.\n* Refusal of the study intervention or follow-up.","ALL","18 Years","84 Years",{"count":108,"type":109},54,"ESTIMATED","INTERVENTIONAL",[112],"NA","This prospective randomized non-inferiority trial is designed to compare postoperative analgesic effect of transversalis fascia plane block and posterior quadratus lumborum block in hand assisted laparoscopic donor nephrectomy. Posoperative opioid consumption, numeric rating scale pain scores and adverse effects will be assessed during the trial.",[115,116,117,118,119,63],"Analgesia","Donor Nephrectomy","Postoperative Pain","Fascial Plane Block","Quadratus Lumborum Block","NOT_YET_RECRUITING","2026-10-05",{"date":123,"type":124},"2026-10-08","ACTUAL",{"date":126,"type":109},"2026-10",{"date":128,"type":109},"2027-04",{"name":5,"class":6},1]