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NCT07805928
Prospective Feasibility, Analgesic Effectiveness, and Safety Study of a Visual Analog Scale-Guided Multimodal Pain Algorithm After Posterior Rib Remodeling With Osteosynthesis
Conditions: Acute Postoperative Pain, Chest Wall Surgery
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: No
Enrollment: 160
Sponsor: Research Inc
Location: Clinica INO Bogotá
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07805928). StuddyBuddy aggregates publicly available trial information.