[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615344":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":26,"responsibleParty":41,"collaborators":26,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":26,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":70,"whyStopped":26,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":26},{"fullName":5,"class":6},"Pontificia Universidad Catolica de Chile","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Retrolaminar block","EXPERIMENTAL","Participants received retrolaminar block with 0.25% Bupivacaine (20 ml) plus epinephrine (5 mcg\u002Fml), on both sides of the vertebral lamina, and a subcutaneous injection in the area of the surgical incision with 20 ml of the same concentration and dose used previously.",[13],"Procedure: retrolaminar block",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham block","SHAM_COMPARATOR","Participants received a retrolaminar sham block with 0.9% saline solution (20 ml), on both sides of the vertebra lamina, and a subcutaneous injection in the area of the surgical incision with 20 ml of the same concentration and dose used previously.",[19],"Procedure: Sham block",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","retrolaminar block","Retrolaminar block with bupivacaine and epinephrine on both sides of the vertebral lamina, and subcutaneous injection in the area of the surgical incision.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Sham block in the retrolaminar area with saline solution on both sides of the vertebral lamina, and subcutaneous injection in the area of the surgical incision.",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Juan Carlos De la Cuadra-Fontaine, MD","CONTACT","5695337297","juancarl@ucchristus.cl",{"name":37,"role":33,"phone":38,"phoneExt":39,"email":40},"Victor Contreras, MSN","56223543414","3414","vecontre@uc.cl",{"type":42,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100615344","effectiveness-of-retrolaminar-block-in-lumbar-spine-fusion-with-multimodal-analgesia-100615344",false,"NCT07291388","Effectiveness of Retrolaminar Block in Lumbar Spine Fusion With Multimodal Analgesia","Effectiveness of Retrolaminar Block in Reducing Postoperative Opioid Consumption in Patients Undergoing Lumbar Spine Fusion With Multimodal Analgesia","RBLUF","Inclusion Criteria:\n\n* Adults aged 18-75 years, scheduled for lumbar spine fusion surgery by a trauma team\n* American Society of Anesthesiologists (ASA) Classification I-III\n* Willing and able to provide written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* History of chronic use of strong or weak opioids for more than 3 months.\n* Diagnosis of chronic pain and treatment by a pain management team.\n* ASA score greater than or equal to 4.\n* Patients with prior lumbar spine surgery. Spinal instrumentation at the surgical site.\n* Estimated creatinine clearance less than 60 ml\u002Fmin.\n* Coagulation disorder or abnormal coagulation tests.\n* Infection at the surgical site.\n* Weight less than 50 kg.\n* Altered mental status that prevents reliable evaluation.\n* Allergy to local anesthetics or analgesic drugs used in the study.\n* Patients with contraindications to peripheral nerve blocks.\n* Lumbar spine fixation due to oncologic disease or acute trauma.\n* Use of intraoperative neuromonitoring and TIVA.",true,"ALL","18 Years","75 Years",{"count":56,"type":57},44,"ESTIMATED","INTERVENTIONAL",[60],"NA","This randomized, blinded, controlled clinical trial aims to evaluate the effectiveness of ultrasound-guided retrolaminar block in reducing postoperative opioid consumption in patients undergoing lumbar spine fusion surgery under multimodal analgesia.\n\nThe participants will:\n\n* Be randomly assigned in a 1:1 ratio to receive either a retrolaminar block with 0.25% bupivacaine plus epinephrine or a sham block (normal saline) prior to surgical incision.\n* Receive standardized multimodal analgesia.\n* Have follow-up by the Acute Pain Unit during the first 3 days, to assess opioid consumption (morphine) in 24 hours, pain intensity measured by Numeric Rating Scale, quality of recovery assessed by the QoR-15 questionnaire, intraoperative blood loss, and postoperative complications.",[63,64,65],"Acute Pain","Anesthesia","Lumbar Spine Disease",[67,23,68,69],"acute pain","regional anesthesia","lumbar arthrodesis","NOT_YET_RECRUITING","2025-12-05",{"date":73,"type":74},"2025-12-18","ACTUAL",{"date":76,"type":57},"2025-12",{"date":78,"type":57},"2027-03",{"name":5,"class":6}]