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NCT Number: NCT07805928

Prospective Feasibility, Analgesic Effectiveness, and Safety Study of a Visual Analog Scale-Guided Multimodal Pain Algorithm After Posterior Rib Remodeling With Osteosynthesis

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VAS-Guided Multimodal Analgesia Algorithm

Procedure

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.

Ultrasound-Guided Thoracic Wall Regional Block

Procedure

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.

Primary outcomes

  1. Proportion of Scheduled Pain Assessments With VAS 3 or Lower

    Time frame: 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 outcomes

  1. Five-Day Pain Burden

    Time frame: 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.

  2. Use of Rescue Analgesia or Regional Block

    Time frame: 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.

  3. Cumulative Rescue Opioid Consumption

    Time frame: 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.

  4. Incidence of Analgesia-Related Adverse Events

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hugo Aguilar, MD, Plastic surgeon

CONTACT

[email protected]

+57 301 6918526

Sponsors and collaborators

Lead sponsor

Research Inc

Industry

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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