Prospective Feasibility, Analgesic Effectiveness, and Safety Study of a Visual Analog Scale-Guided Multimodal Pain Algorithm After Posterior Rib Remodeling With Osteosynthesis
1. september 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Antatt)
160
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: hugo Aguilar, MD, Plastic surgeon
- Telefonnummer: +57 301 6918526
- E-post: havplasticacademy@gmail.com
Studiesteder
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-
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Bogotá, Colombia
- Rekruttering
- Clinica INO
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Ta kontakt med:
- hugo Aguilar, MD, Plastic surgeon
- Telefonnummer: +57 3016918526
- E-post: havplasticacademy@gmail.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Adults undergoing posterior aesthetic rib remodeling with osteosynthesis who receive the standardized postoperative analgesia algorithm.
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Proportion of Scheduled Pain Assessments With VAS 3 or Lower
Tidsramme: At 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 hours after surgery. 1 day
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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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Five-Day Pain Burden
Tidsramme: 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.
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From 6 hours through 120 hours after surgery, using scheduled assessments at 6, 12, 24, and every 12 hours thereafter. 5 days
|
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Use of Rescue Analgesia or Regional Block
Tidsramme: From surgery through postoperative hour 120. 5 days
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Proportion of participants receiving unscheduled rescue analgesia, new or repeat regional block, PCA dose increase, or another escalation outside the initial assigned tier.
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From surgery through postoperative hour 120. 5 days
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Cumulative Rescue Opioid Consumption
Tidsramme: From surgery through postoperative hour 120. 5 days
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Total rescue opioid dose converted to intravenous morphine milligram equivalents.
Protocol drugs that are not opioids will be summarized separately.
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From surgery through postoperative hour 120. 5 days
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Incidence of Analgesia-Related Adverse Events
Tidsramme: From initiation of postoperative analgesia through postoperative hour 120. 5 days
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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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Hugo Aguilar, MD, plastic surgery
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. januar 2024
Primær fullføring (Faktiske)
12. desember 2025
Studiet fullført (Antatt)
1. desember 2026
Datoer for studieregistrering
Først innsendt
1. september 2026
Først innsendt som oppfylte QC-kriteriene
1. september 2026
Først lagt ut (Faktiske)
8. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 013 (Nahrain Medical Research Collective (NMRC))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Not comtempled in the patient informed consent
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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