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Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07805928). StuddyBuddy aggregates publicly available trial information.