Prospective Feasibility, Analgesic Effectiveness, and Safety Study of a Visual Analog Scale-Guided Multimodal Pain Algorithm After Posterior Rib Remodeling With Osteosynthesis
2026年9月1日 更新者：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.
研究概览
地位
招聘中
详细说明
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.
研究类型
观察性的
注册 (估计的)
160
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：hugo Aguilar, MD, Plastic surgeon
- 电话号码：+57 301 6918526
- 邮箱：havplasticacademy@gmail.com
学习地点
-
-
-
Bogotá、哥伦比亚
- 招聘中
- Clinica INO
-
接触：
- hugo Aguilar, MD, Plastic surgeon
- 电话号码：+57 3016918526
- 邮箱：havplasticacademy@gmail.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
取样方法
非概率样本
研究人群
Adults undergoing posterior aesthetic rib remodeling with osteosynthesis who receive the standardized postoperative analgesia algorithm.
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of Scheduled Pain Assessments With VAS 3 or Lower
大体时间：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.
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At 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 hours after surgery. 1 day
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Five-Day Pain Burden
大体时间：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.
|
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
大体时间：From surgery through postoperative hour 120. 5 days
|
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
大体时间：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
大体时间：From initiation of postoperative analgesia through postoperative hour 120. 5 days
|
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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Hugo Aguilar, MD, plastic surgery
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年1月1日
初级完成 (实际的)
2025年12月12日
研究完成 (估计的)
2026年12月1日
研究注册日期
首次提交
2026年9月1日
首先提交符合 QC 标准的
2026年9月1日
首次发布 (实际的)
2026年9月8日
研究记录更新
最后更新发布 (实际的)
2026年9月8日
上次提交的符合 QC 标准的更新
2026年9月1日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他研究编号
- 013 (Nahrain Medical Research Collective (NMRC))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Not comtempled in the patient informed consent
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.