About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Adults undergoing posterior aesthetic rib remodeling with osteosynthesis who receive the standardized postoperative analgesia algorithm.
Trial design
Cohort
Prospective
Treatments tested in this trial
VAS-Guided Multimodal Analgesia Algorithm
Procedure/SurgeryProposed 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/NMDA 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/group(s): VAS-Guided RIBOSS Analgesia Algorithm.
Ultrasound-Guided Thoracic Wall Regional Block
Procedure/SurgeryA 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/group(s): VAS-Guided RIBOSS Analgesia Algorithm.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
Cumulative Rescue Opioid Consumption
Total rescue opioid dose converted to intravenous morphine milligram equivalents. Protocol drugs that are not opioids will be summarized separately.
Incidence of Analgesia-Related Adverse Events
Proportion of participants with treated nausea/vomiting, excessive sedation, respiratory depression, hallucinations, dizziness, hemodynamic instability, local-anesthetic toxicity, neurologic deficit, block-site complication, or another event adjudicated as analgesia related.
Sponsors and contacts
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