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 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Beräknad)
160
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: hugo Aguilar, MD, Plastic surgeon
- Telefonnummer: +57 301 6918526
- E-post: havplasticacademy@gmail.com
Studieorter
-
-
-
Bogotá, Colombia
- Rekrytering
- Clinica INO
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Kontakt:
- hugo Aguilar, MD, Plastic surgeon
- Telefonnummer: +57 3016918526
- E-post: havplasticacademy@gmail.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Adults undergoing posterior aesthetic rib remodeling with osteosynthesis who receive the standardized postoperative analgesia algorithm.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Proportion of Scheduled Pain Assessments With VAS 3 or Lower
Tidsram: 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
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Five-Day Pain Burden
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Hugo Aguilar, MD, plastic surgery
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 januari 2024
Primärt slutförande (Faktisk)
12 december 2025
Avslutad studie (Beräknad)
1 december 2026
Studieregistreringsdatum
Först inskickad
1 september 2026
Först inskickad som uppfyllde QC-kriterierna
1 september 2026
Första postat (Faktisk)
8 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
8 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 013 (Nahrain Medical Research Collective (NMRC))
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
Not comtempled in the patient informed consent
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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