[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654980":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":33,"studyPopulation":34,"armGroups":35,"interventions":42,"overallOfficials":52,"centralContacts":56,"locations":62,"responsibleParty":79,"collaborators":29,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":29,"eligibilityCriteria":86,"healthyVolunteers":83,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":93,"studyType":94,"phases":29,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":65,"whyStopped":29,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Research Inc","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of Scheduled Pain Assessments With VAS 3 or Lower","Number of protocol-scheduled assessments with pain intensity 0 to 3 on a 0-to-10 visual analog or numeric rating scale divided by the total number of completed scheduled assessments, reported overall and by postoperative time point.","At 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 hours after surgery. 1 day",[14,18,22,25],{"measure":15,"description":16,"timeFrame":17},"Five-Day Pain Burden","Area under the curve of pain intensity over time using scheduled 0-to-10 scores; lower values indicate less cumulative pain.","From 6 hours through 120 hours after surgery, using scheduled assessments at 6, 12, 24, and every 12 hours thereafter. 5 days",{"measure":19,"description":20,"timeFrame":21},"Use of Rescue Analgesia or Regional Block","Proportion of participants receiving unscheduled rescue analgesia, new or repeat regional block, PCA dose increase, or another escalation outside the initial assigned tier.","From surgery through postoperative hour 120. 5 days",{"measure":23,"description":24,"timeFrame":21},"Cumulative Rescue Opioid Consumption","Total rescue opioid dose converted to intravenous morphine milligram equivalents. Protocol drugs that are not opioids will be summarized separately.",{"measure":26,"description":27,"timeFrame":28},"Incidence of Analgesia-Related Adverse Events","Proportion of participants with treated nausea\u002Fvomiting, excessive sedation, respiratory depression, hallucinations, dizziness, hemodynamic instability, local-anesthetic toxicity, neurologic deficit, block-site complication, or another event adjudicated as analgesia related.","From initiation of postoperative analgesia through postoperative hour 120. 5 days",null,{"allocation":29,"interventionModel":29,"interventionModelDescription":29,"primaryPurpose":29,"observationalModel":31,"timePerspective":32,"maskingInfo":29},"COHORT","PROSPECTIVE","After RIBOSS surgery, participants will enter a structured analgesia pathway based on repeated 0-to-10 pain scores. Mild pain will receive a nonopioid base regimen; moderate pain will prompt addition of an NMDA-directed and elastomeric multimodal strategy with optional regional block; severe pain will prompt full multimodal infusion and regional rescue when safe. Assessments will occur at 6, 12, and 24 hours and every 12 hours through day 5. Each assessment will document pain at rest and movement, active treatment tier, rescue interventions, sedation, respiratory status, nausea\u002Fvomiting, and other adverse events. The study will determine whether the algorithm consistently achieves adequate analgesia and can be implemented safely and reproducibly.","Adults undergoing posterior aesthetic rib remodeling with osteosynthesis who receive the standardized postoperative analgesia algorithm.",[36],{"label":37,"type":29,"description":38,"interventionNames":39},"VAS-Guided RIBOSS Analgesia Algorithm","All participants receive algorithm-guided treatment. The active treatment tier changes according to scheduled VAS assessment and prespecified safety rules.",[40,41],"Procedure: VAS-Guided Multimodal Analgesia Algorithm","Procedure: Ultrasound-Guided Thoracic Wall Regional Block",[43,48],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":29},"PROCEDURE","VAS-Guided Multimodal Analgesia Algorithm","Proposed operational tiers: VAS 0-3, NSAID plus acetaminophen, optional magnesium or pregabalin, without PCA or mandatory block; VAS 4-5, base analgesia plus low-dose ketamine\u002FNMDA strategy and elastomeric multimodal infusion, with optional regional block; VAS 6-10, base analgesia plus multimodal elastomeric infusion and mandatory rescue regional technique when not contraindicated. Reassessment occurs every 6 to 12 hours; treatment is reduced when VAS remains below 3 and escalated when VAS remains above 5. Exact drugs, doses, contraindications, and monitoring are specified in the final anesthesia appendix. Linked arm\u002Fgroup(s): VAS-Guided RIBOSS Analgesia Algorithm.",[37],{"type":44,"name":49,"description":50,"armGroupLabels":51,"otherNames":29},"Ultrasound-Guided Thoracic Wall Regional Block","A paravertebral, erector spinae plane, serratus plane, epidural, or other approved block may be used according to the locked algorithm, anatomy, and anesthesia judgment. Technique, local anesthetic dose, and safety monitoring will be standardized. Linked arm\u002Fgroup(s): VAS-Guided RIBOSS Analgesia Algorithm.",[37],[53],{"name":54,"affiliation":29,"role":55},"Hugo Aguilar, MD, plastic surgery","PRINCIPAL_INVESTIGATOR",[57],{"name":58,"role":59,"phone":60,"phoneExt":29,"email":61},"Hugo Aguilar, MD, Plastic surgeon","CONTACT","+57 301 6918526","havplasticacademy@gmail.com",[63],{"facility":64,"status":65,"city":66,"state":29,"zip":29,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Clinica INO","RECRUITING","Bogotá","Colombia","CO",{"type":70,"coordinates":71},"Point",[72,73],-74.08175,4.60971,{"lat":73,"lon":72},[76],{"name":77,"role":59,"phone":78,"phoneExt":29,"email":61},"hugo Aguilar, MD, Plastic surgeon","+57 3016918526",{"type":80,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100654980","prospective-feasibility-analgesic-effectiveness-and-safety-study-of-a-visual-analog-scale-guided-multimodal-pain-algorithm-after-posterior-rib-remodeling-with-osteosynthesis-100654980",false,"NCT07805928","Prospective Feasibility, Analgesic Effectiveness, and Safety Study of a Visual Analog Scale-Guided Multimodal Pain Algorithm After Posterior Rib Remodeling With Osteosynthesis","Inclusion Criteria:\n\n* Age 18 to 55 years.\n* Scheduled for posterior aesthetic rib remodeling with osteosynthesis using the standardized RIBOSS technique.\n* Ability to understand and use a 0-to-10 visual analog or numeric pain scale.\n* Availability for scheduled pain assessments through postoperative hour 120.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Chronic opioid use or opioid use disorder requiring an individualized perioperative plan.\n* Contraindication to the base nonsteroidal anti-inflammatory drug or acetaminophen regimen and inability to use the predefined alternative pathway.\n* Contraindication to ketamine, lidocaine, dexmedetomidine, or the planned regional block when those components may be required.\n* Severe hepatic, renal, cardiac, neurologic, or psychiatric condition judged to make the algorithm unsafe.\n* Pregnancy or breastfeeding.\n* Inability to provide reliable pain scores or complete five-day monitoring.","ALL","18 Years","55 Years",{"count":91,"type":92},160,"ESTIMATED","15 Days","OBSERVATIONAL","This prospective single-group study will evaluate a visual analog scale-guided multimodal analgesia algorithm during the first five days after posterior rib remodeling with osteosynthesis. Pain will be assessed at 6, 12, and 24 hours and every 12 hours thereafter through 120 hours. Treatment will be escalated or reduced according to prespecified pain tiers and safety rules. The primary outcome is the proportion of scheduled assessments with pain scores of 3 or lower. Protocol adherence, rescue treatment, medication exposure, and adverse events will also be measured.",[97,98],"Acute Postoperative Pain","Chest Wall Surgery",[100,101,102,103,104,105],"RIBOSS","Rib Remodeling","Postoperative Pain","Visual Analog Scale","Multimodal Analgesia;","Elastomeric Pump","2026-09-01",{"date":108,"type":109},"2026-09-08","ACTUAL",{"date":111,"type":109},"2024-01-01",{"date":113,"type":92},"2026-12-01",{"name":5,"class":6},1]