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

NCT07805928 | Recruiting

• 1 other identifier: 013
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Chest Wall Surgery; Acute Postoperative Pain

Keywords

RIBOSS; Rib Remodeling; Postoperative Pain; Visual Analog Scale; Multimodal Analgesia;; Elastomeric Pump

Outcome Measures

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.

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

Secondary Outcomes (4)

• 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

• Use of Rescue Analgesia or Regional Block

  From surgery through postoperative hour 120. 5 days

• Cumulative Rescue Opioid Consumption

  From surgery through postoperative hour 120. 5 days

• Incidence of Analgesia-Related Adverse Events

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

Study Arms (1)

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.

Procedure: VAS-Guided Multimodal Analgesia Algorithm; Procedure: Ultrasound-Guided Thoracic Wall Regional Block

Interventions

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.

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.

VAS-Guided RIBOSS Analgesia Algorithm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adults undergoing posterior aesthetic rib remodeling with osteosynthesis who receive the standardized postoperative analgesia algorithm.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Inc: lead

Study Sites (1)

Clinica INO

Bogotá, Colombia

RECRUITING

Related Publications (4)

• 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.

  PMID: 38710099 BACKGROUND

• 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.

  PMID: 38204869 BACKGROUND

• 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.

  PMID: 38115833 BACKGROUND

• 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.

  PMID: 41983160 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Hugo Aguilar, MD, plastic surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hugo Aguilar, MD, Plastic surgeon

CONTACT

+57 301 6918526; havplasticacademy@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 8, 2026
• Study Start: January 1, 2024
• Primary Completion: December 12, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)