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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Colombia
Clinica INO
RECRUITING
Bogotá
Contact Information
Primary
Hugo Aguilar, MD, Plastic surgeon
havplasticacademy@gmail.com
+57 301 6918526
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 160
Treatments
VAS-Guided RIBOSS Analgesia Algorithm
All participants receive algorithm-guided treatment. The active treatment tier changes according to scheduled VAS assessment and prespecified safety rules.
Related Therapeutic Areas
Sponsors
Leads: Research Inc

This content was sourced from clinicaltrials.gov