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Prospective Feasibility, Analgesic Effectiveness, and Safety Study of a Visual Analog Scale-Guided Multimodal Pain Algorithm After Posterior Rib Remodeling With Osteosynthesis

Recruitingn/aAges 18 Years - 55 YearsAllResearch Inc
NCT07805928 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 18 to 55 years. * Scheduled for posterior aesthetic rib remodeling with osteosynthesis using the standardized RIBOSS technique. * Ability to understand and use a 0-to-10 visual analog or numeric pain scale. * Availability for scheduled pain assessments through postoperative hour 120. * Written informed consent. Exclusion Criteria: * Chronic opioid use or opioid use disorder requiring an individualized perioperative plan. * Contraindication to the base nonsteroidal anti-inflammatory drug or acetaminophen regimen and inability to use the predefined alternative pathway. * Contraindication to ketamine, lidocaine, dexmedetomidine, or the planned regional block when those components may be required. * Severe hepatic, renal, cardiac, neurologic, or psychiatric condition judged to make the algorithm unsafe. * Pregnancy or breastfeeding. * Inability to provide reliable pain scores or complete five-day monitoring.
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What it tests

  • VAS-Guided Multimodal Analgesia Algorithm
  • Ultrasound-Guided Thoracic Wall Regional Block
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Where

1 site
Clinica INO
Bogotá, Colombia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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