Acute Postoperative PainNCT07805928
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 of Acute Postoperative Pain and Chest Wall Surgery, run by Research Inc at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Acute Postoperative Pain, Chest Wall Surgery
- What is being tested?
- VAS-Guided Multimodal Analgesia Algorithm and Ultrasound-Guided Thoracic Wall Regional Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jan 2024to 1 Dec 2026
- How long will I take part?
- 15 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adults undergoing posterior aesthetic rib remodeling with osteosynthesis who receive the standardized postoperative analgesia algorithm.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
Clinica INO
Bogotá
hugo Aguilar, MD, Plastic surgeon, +57 3016918526, havplasticacademy@gmail.com
About this study
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.
- Conditions
- Acute Postoperative Pain, Chest Wall Surgery
- Being tested
- VAS-Guided Multimodal Analgesia Algorithm, Ultrasound-Guided Thoracic Wall Regional Block
- Keywords
- RIBOSS, Rib Remodeling, Postoperative Pain, Visual Analog Scale, Multimodal Analgesia;, Elastomeric Pump
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAS-Guided Multimodal Analgesia AlgorithmProcedure or 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 BlockProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: VAS-Guided Multimodal Analgesia Algorithm; Procedure: Ultrasound-Guided Thoracic Wall Regional Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Area under the curve of pain intensity over time using scheduled 0-to-10 scores; lower values indicate less cumulative pain.
Measured: 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
Proportion of participants receiving unscheduled rescue analgesia, new or repeat regional block, PCA dose increase, or another escalation outside the initial assigned tier.
Measured: From surgery through postoperative hour 120. 5 days
Cumulative Rescue Opioid Consumption
Total rescue opioid dose converted to intravenous morphine milligram equivalents. Protocol drugs that are not opioids will be summarized separately.
Measured: From surgery through postoperative hour 120. 5 days
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.
Measured: From initiation of postoperative analgesia through postoperative hour 120. 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Jan 2024
- Primary completion12 Dec 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Research Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hugo Aguilar, MD, plastic surgery, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805928
- Sponsor's protocol ID
- 013
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not comtempled in the patient informed consent
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 38710099Onate 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 38204869Manzaneda 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 38115833Aguilar 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Feasibility, Analgesic Effectiveness, and Safety Study of a Visual Analog Scale-Guided Multimodal Pain Algorithm After Posterior Rib Remodeling With Osteosynthesis
- ClinicalTrials.gov ID
- NCT07805928
- Acronym / sponsor ID
- 013
- Conditions
- Acute Postoperative Pain, Chest Wall Surgery
- Keywords
- RIBOSS, Rib Remodeling, Postoperative Pain, Visual Analog Scale, Multimodal Analgesia;, Elastomeric Pump
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Research IncIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VAS-Guided RIBOSS Analgesia Algorithm | – | Procedure: VAS-Guided Multimodal Analgesia Algorithm, Procedure: Ultrasound-Guided Thoracic Wall Regional BlockAll participants receive algorithm-guided treatment. The active treatment tier changes according to scheduled VAS assessment and prespecified safety rules. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adults undergoing posterior aesthetic rib remodeling with osteosynthesis who receive the standardized postoperative analgesia algorithm.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VAS-Guided Multimodal Analgesia AlgorithmProposed 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. | Procedure or surgery | VAS-Guided RIBOSS Analgesia Algorithm |
| Ultrasound-Guided Thoracic Wall Regional BlockA 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. | Procedure or surgery | VAS-Guided RIBOSS Analgesia Algorithm |
Primary outcome
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.
4 secondary outcomes
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
Use of Rescue Analgesia or Regional Block
Time frame: From surgery through postoperative hour 120. 5 days
Cumulative Rescue Opioid Consumption
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 38710099Aguilar 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.
- Background: PubMed 38204869Onate 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.
- Background: PubMed 38115833Manzaneda 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.
- Background: PubMed 41983160Aguilar 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.
- Individual participant dataSharing planned: No. Not comtempled in the patient informed consent
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hugo Aguilar, MD, plastic surgery principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Postoperative Pain and Chest Wall Surgery, run by Research Inc at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hugo Aguilar, MD, Plastic surgeon (+57 301 6918526, havplasticacademy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07805928, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.