Prospective Feasibility, Analgesic Effectiveness, and Safety Study of a Visual Analog Scale-Guided Multimodal Pain Algorithm After Posterior Rib Remodeling With Osteosynthesis
September 1, 2026 updated by: Research Inc
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.
Study Overview
Status
Recruiting
Conditions
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.
Study Type
Observational
Enrollment (Estimated)
160
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hugo Aguilar, MD, Plastic surgeon
- Phone Number: +57 301 6918526
- Email: havplasticacademy@gmail.com
Study Locations
-
-
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Bogotá, Colombia
- Recruiting
- Clinica INO
-
Contact:
- hugo Aguilar, MD, Plastic surgeon
- Phone Number: +57 3016918526
- Email: havplasticacademy@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adults undergoing posterior aesthetic rib remodeling with osteosynthesis who receive the standardized postoperative analgesia algorithm.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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At 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 hours after surgery. 1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From 6 hours through 120 hours after surgery, using scheduled assessments at 6, 12, 24, and every 12 hours thereafter. 5 days
|
|
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.
|
From surgery through postoperative hour 120. 5 days
|
|
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.
|
From surgery through postoperative hour 120. 5 days
|
|
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.
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From initiation of postoperative analgesia through postoperative hour 120. 5 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hugo Aguilar, MD, plastic surgery
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Onate Valdivieso C, Onate Valdivieso D, Hoyos AE, Perez Pachon ME, Aguilar Villa H, Michels PJA, Viera A, Benavides JE, Villabona SJ, Ramirez B. Ultrasonic- and Ultrasound-assisted Improvement of Silhouette of the Torso: Bone Structure High-definition Remodeling (Part I). Plast Reconstr Surg Glob Open. 2024 Jan 10;12(1):e5513. doi: 10.1097/GOX.0000000000005513. eCollection 2024 Jan.
- Aguilar Villa H, Villabona-Florez SJ, Hoyos AE, Perez Pachon ME, Serrano-Reyes HM, Diaz Sandoval CJ. Aesthetic Rib Cage Remodeling with Osteosynthesis: Body Structural High-Definition Reshaping (Rib Osteotomy with Osteosynthesis Stabilization). Plast Reconstr Surg. 2025 Feb 1;155(2):279-288. doi: 10.1097/PRS.0000000000011512. Epub 2024 May 6.
- Manzaneda Cipriani RM, Duran Vega H, Cala Uribe L, Viaro M, Adrianzen GA, Botelho DL. Waist Remodeling without Incision, with Ultrasound-guided Monocortical Fracture. Plast Reconstr Surg Glob Open. 2023 Dec 19;11(12):e5499. doi: 10.1097/GOX.0000000000005499. eCollection 2023 Dec.
- Aguilar HA, Hoyos AE, Ramirez B, Kazbek K, Viacheslav N, Villabona SJ, Serrano HM, Perez Pachon ME, Valdivieso DO, Valdivieso CO, Kazbek G, Proto R, Verdugo JP, Varela A. Global Survey on Rib Remodeling Techniques: Assessing Complications and Safety in Waistline Contouring. Plast Reconstr Surg Glob Open. 2026 Apr 13;14(4):e7609. doi: 10.1097/GOX.0000000000007609. eCollection 2026 Apr.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2024
Primary Completion (Actual)
December 12, 2025
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
September 1, 2026
First Submitted That Met QC Criteria
September 1, 2026
First Posted (Actual)
September 8, 2026
Study Record Updates
Last Update Posted (Actual)
September 8, 2026
Last Update Submitted That Met QC Criteria
September 1, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 013 (Nahrain Medical Research Collective (NMRC))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Not comtempled in the patient informed consent
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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