ClinicalTrials.gg
RecruitingNCT07805928Updated Sep 8, 2026

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

An observational study in Acute Postoperative Pain and Chest Wall Surgery, sponsored by Research Inc. Recruiting at 1 site in Colombia. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Research Inc · Observational

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
160
Ages
18 Years to 55 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 19 studies in Pain, Postoperative with a site in Colombia — 4 open to participants now, 4 under way, none of them phase 3. Pain, Postoperative · Colombia.

Started
2024
the only one that year
Observational
5 of 19
3 open now
Registered
17th of 19
by date
Lead sponsor
2 of 19
Research Inc

Among the 19 studies in Pain, Postoperative with a site in Colombia, this one is the only one that started in 2024, is one of 5 observational ones, and was the 17th registered.

Pain, Postoperative

5,644 studies on the registry are indexed under Pain, Postoperative; 1,229 are open to participants now.

Browse Pain, Postoperative studies →

Open to participants now

4 of the 19 studies in Pain, Postoperative with a site in Colombia are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in Colombia have not opened yet or have stopped. Only those recruiting at a site in Colombia →

Who these studies take

Of the 678 Pain, Postoperative studies recruiting now, 241 (36%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.

This study: 18 Years to 55 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 19 studies in Pain, Postoperative with a site in Colombia, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Acute Postoperative Pain
  • Chest Wall Surgery

Browse trials for

Keywords

  • RIBOSS
  • Rib Remodeling
  • Postoperative Pain
  • Visual Analog Scale
  • Multimodal Analgesia;
  • Elastomeric Pump
04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria:

  • Chronic opioid use or opioid use disorder requiring an individualized perioperative plan.
  • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
160 participants (estimated)
Target follow-up
15 Days
Patient registry
Yes

Groups and cohorts

  • 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

  • ProcedureVAS-Guided Multimodal Analgesia Algorithm

    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.

  • ProcedureUltrasound-Guided Thoracic Wall Regional Block

    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.

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 38710099 ↗
  • 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. PubMed 38204869 ↗
  • 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. PubMed 38115833 ↗
  • 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. PubMed 41983160 ↗

Individual participant data

Plan to share: No — Not comtempled in the patient informed consent

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2024 to primary completion in Dec 2025, 23 months.

Of 395 observational studies under Pain, Postoperative, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 33. This study's 23 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 1, 2026
First posted
Sep 8, 2026
StartActual
Jan 1, 2024
Primary completionActual
Dec 12, 2025
CompletionEst.
Dec 1, 2026
Last update
Sep 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07805928
Lead sponsor
Research Inc
Responsible party
Sponsor
First posted
Sep 8, 2026
Start date
Jan 1, 2024
Primary completion
Dec 12, 2025
Completion
Dec 1, 2026 (estimated)
Last update
Sep 8, 2026

Study contacts

Hugo Aguilar, MD, Plastic surgeon
Contact
havplasticacademy@gmail.com
+57 301 6918526
Hugo Aguilar, MD, plastic surgery
principal investigator

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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