Acute Postoperative Pain, Chest Wall Surgery
Conditions
Keywords
RIBOSS, Rib Remodeling, Postoperative Pain, Visual Analog Scale, Multimodal Analgesia;, Elastomeric Pump
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.
Detailed description
After RIBOSS surgery, participants will enter a structured analgesia pathway based on repeated 0-to-10 pain scores. Mild pain will receive a nonopioid base regimen; moderate pain will prompt addition of an NMDA-directed and elastomeric multimodal strategy with optional regional block; severe pain will prompt full multimodal infusion and regional rescue when safe. Assessments will occur at 6, 12, and 24 hours and every 12 hours through day 5. Each assessment will document pain at rest and movement, active treatment tier, rescue interventions, sedation, respiratory status, nausea/vomiting, and other adverse events. The study will determine whether the algorithm consistently achieves adequate analgesia and can be implemented safely and reproducibly.
Interventions
PROCEDUREVAS-Guided Multimodal Analgesia Algorithm
Proposed 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.
PROCEDUREUltrasound-Guided Thoracic Wall Regional Block
A 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.
Sponsors
Research Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Scheduled Pain Assessments With VAS 3 or Lower | At 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 hours after surgery. 1 day | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Analgesia-Related Adverse Events | From initiation of postoperative analgesia through postoperative hour 120. 5 days | 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. |
| Five-Day Pain Burden | From 6 hours through 120 hours after surgery, using scheduled assessments at 6, 12, 24, and every 12 hours thereafter. 5 days | 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 | From surgery through postoperative hour 120. 5 days | 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 | From surgery through postoperative hour 120. 5 days | Total rescue opioid dose converted to intravenous morphine milligram equivalents. Protocol drugs that are not opioids will be summarized separately. |
Countries
Colombia
Contacts
CONTACTHugo Aguilar, MD, Plastic surgeon
PRINCIPAL_INVESTIGATORHugo Aguilar, MD, plastic surgery
Outcome results
None listed