Long Term Safety of Preoperative Percutaneous Intercostal Cryoneurolysis (CRYOFUP)
2026年6月17日 更新者：Stefano Mariconti、Papa Giovanni XXIII Hospital
Long Term Safety of Preoperative Percutaneous Intercostal Cryoneurolysis: Neuropathic Pain, Quality of Life and Sensory Recovery in a Paediatric Cohort Following Pectus Excavatum Repair
Follow up of patients who underwent percutaneous cryoneurolysis for pectus excavatum repair (the Nuss procedure) pain management
研究概览
地位
招聘中
详细说明
Follow up of patients after receiving percutaneous cryoneurolysis for pectus excavatum repair, who undergo a physical examination and a neurosensory assessment of the chest wall at 1, 3, 6, 12, and 24 months postoperatively, corresponding to the scheduled follow-up visits.
In addition, to evaluate neuropathic pain, chronic pain, and quality of life, patients complete validated questionnaires.
研究类型
观察性的
注册 (估计的)
50
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：Stefano Mariconti, MD
- 电话号码：0039 + 0352675149
- 邮箱：smariconti@asst-pg23.it
学习地点
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BG
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Bergamo、BG、意大利、24127
- 招聘中
- Asst Papa Giovanni Xxiii
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接触：
- Stefano Mariconti, MD
- 电话号码：0039 + 0352675149
- 邮箱：smariconti@asst-pg23.it
-
-
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
- 孩子
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Adolescents older than 14 years and young adults who underwent percutaneous cryoanalgesia between July 1, 2022 and December 31, 2026.
描述
Inclusion Criteria:
- Patients who underwent percutaneous cryoneurolysis.
- Patients who underwent surgical correction of pectus excavatum according to the Nuss procedure.
- Signed informed consent.
Exclusion Criteria:
- Refusal to participate in the study
- Peripheral nervous system disorders
- Age < 14 years
- Failure to attend scheduled follow-up visits
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 |
|---|---|
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Patients who underwent percutaneous cryoneurolysis for the Nuss procedure pain management
All patients who underwent surgical correction of pectus excavatum via the Nuss procedure between July 1, 2022 and February 28, 2026 are considered eligible for enrollment. Additionally, for the prospective component, patients scheduled for surgery up to December 31, 2026 at the Pediatric Surgery department of our institution will be considered eligible. Inclusion criteria: Age greater than 14 years. Patients who underwent percutaneous cryoneurolysis. Patients who underwent surgical correction of pectus excavatum according to the Nuss procedure. Exclusion criteria: Patients who withhold consent to participate in the study, patients with pre-existing neurological conditions, and patients who do not attend the scheduled follow-up visits will be excluded from the study. |
Assessment tools include validated questionnaires - the S-LANSS (Self-report Leeds Assessment of Neuropathic Symptoms and Signs, range 0-24, higher scores indicating greater likelihood of neuropathic pain) and the PedsQL™ (Pediatric Quality of Life Inventory, v4.0, Adolescent/Young Adult Report, range 0-100, higher scores indicating better health-related quality of life) - together with the Patient Self-Assessment Sensory Scale (range 0-10, 0 indicating no sensitivity and 10 indicating normal sensitivity) and a structured physical examination of thoracic sensitivity.
These tools are administered at pre-specified follow-up timepoints.
The physical examination assesses four sensory modalities corresponding to specific afferent fibre classes of the intercostal nerves: cold thermal sensation (Aδ fibres, ice-water contact, 4-10°C), warm thermal sensation (C fibres, ~40°C water), light touch (Aβ fibres, camel-hair brush), and pressure sensitivity (Aβ fibres, Von Frey filament 5.07/10g)
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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 |
|---|---|---|
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Self-report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) questionnaire results
大体时间：The same patients are followed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how S-LANSS score evolve over time.
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To assess the incidence of neuropathic pain using the validated S-LANSS (Self-report Leeds Assessment of Neuropathic Symptoms and Signs) scale, administered at the scheduled follow-up visits.
The S-LANSS score ranges from 0 to 24, with higher scores indicating greater likelihood and severity of neuropathic pain (a score ≥12 is suggestive of pain of predominantly neuropathic origin
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The same patients are followed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how S-LANSS score evolve over time.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pediatric Quality of Life Inventory (PedsQL) questionnaire
大体时间：The same patients are assessed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how quality of life evolve over time.
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To describe the quality of life of patients using a specific validated questionnaire appropriate for adolescents and young adults (Pediatric Quality of Life Inventory - PedsQL™ version 4.0 for adolescents and young adults).
The PedsQL total score ranges from 0 to 100, with higher scores indicating better health-related quality of life.
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The same patients are assessed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how quality of life evolve over time.
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chronic postoperative pain (CPSP) assessment
大体时间：The same patients are followed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how chronic pain evolve over time.
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To describe the incidence of chronic postoperative pain (CPSP), defined as persistence of pain beyond one month, according to two parameters: direct measurement using the NRS (Numeric Rating Scale) for pain intensity, and indirect measurement through consumption of analgesic medications included in the institutional current protocol (acetaminophen and NSAIDs).
The NRS ranges from 0 (no pain) to 10 (worst possible pain), with higher scores indicating greater pain intensity.
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The same patients are followed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how chronic pain evolve over time.
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sensitivity recovery using the Patient Self-Assessment Sensory Scale
大体时间：The same patients are assessed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how sensitivity recovery evolve over time.
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To describe the evolution of thoracic thermotactile hypoesthesia over time, starting from the day of cryoneurolysis, using the Patient Self-Assessment Sensory Scale.
The scale ranges from 0 to 10, with 0 indicating no sensitivity (complete anaesthesia) and 10 indicating maximal/normal sensitivity, with higher scores indicating better (more complete) sensory recovery.
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The same patients are assessed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how sensitivity recovery evolve over time.
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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。
调查人员
- 学习椅：Ezio Bonanomi, MD、Department of Anesthesia and Intensive Care, Paediatric Anesthesiology and Intensive Care Unit, ASST Papa Giovanni XXIII, Bergamo, Italy.
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)
2025年2月2日
初级完成 (实际的)
2026年6月13日
研究完成 (估计的)
2029年1月15日
研究注册日期
首次提交
2026年6月13日
首先提交符合 QC 标准的
2026年6月13日
首次发布 (实际的)
2026年6月18日
研究记录更新
最后更新发布 (实际的)
2026年6月22日
上次提交的符合 QC 标准的更新
2026年6月17日
最后验证
2026年6月1日
更多信息
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.