NCT07805928 Prospective Feasibility, Analgesic Effectiveness, and Safety Study of a Visual Analog Scale-Guided Multimodal Pain Algorithm After Posterior Rib Remodeling With Osteosynthesis
| NCT ID | NCT07805928 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Research Inc |
| Condition | Acute Postoperative Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 160 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2025-12-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 160 participants in total. It began in 2024-01-01 with a primary completion date of 2025-12-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Hugo Aguilar, MD, plastic surgery
PRINCIPAL INVESTIGATOR
Frequently Asked Questions
Who can join the NCT07805928 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Acute Postoperative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07805928 currently recruiting?
Yes, NCT07805928 is actively recruiting participants. Contact the research team at havplasticacademy@gmail.com for enrollment information.
Where is the NCT07805928 trial being conducted?
This trial is being conducted at Bogotá, Colombia.
Who is sponsoring the NCT07805928 clinical trial?
NCT07805928 is sponsored by Research Inc. The principal investigator is Hugo Aguilar, MD, plastic surgery. The trial plans to enroll 160 participants.