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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-55
SponsorResearch Inc

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • VAS-Guided Multimodal Analgesia Algorithm

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

160 Participants
are divided into 1 treatment group
Group A: VAS-Guided RIBOSS Analgesia Algorithm2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 hours after surgery. 1 day

Secondary outcomes

1

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.

Time frame
From 6 hours through 120 hours after surgery, using scheduled assessments at 6, 12, 24, and every 12 hours thereafter. 5 days
2

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.

Time frame
From surgery through postoperative hour 120. 5 days
3

Cumulative Rescue Opioid Consumption

Total rescue opioid dose converted to intravenous morphine milligram equivalents. Protocol drugs that are not opioids will be summarized separately.

Time frame
From surgery through postoperative hour 120. 5 days
4

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.

Time frame
From initiation of postoperative analgesia through postoperative hour 120. 5 days

Other outcomes

Sponsors and contacts

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