Cryoanalgesia for Pain Management After Pectus Excavatum Repair. COPPER Study (CryoanalgesiafOr Pain Management After Pectus Excavatum Repair): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Quality of Life by PedsQL 23 items
研究概览
简要总结
Cryoanalgesia for pain management after pectus excavatum repair. COPPER study (CryoanalgesiafOr Pain management after Pectus Excavatum Repair): a randomized controlled trial.
Determine if, in patients more than 12 years of age having cryoanalgesia for pectus excavatum repair analgesia improves the standard of care (epidural analgesia) in term of pain relief and return to normal life 2 weeks after surgery.
Randomized active controlled, parallel group, single-centre, trial (category IIb medical device).
88 patients aged more than 12 years of age scheduled for pectus excavatum repair. After randomization, patients will receive intraoperative cryo-analgesia or standard of care (epidural-analgesia).
PedsQLscale (23 items) two weeks after surgery.
Patients will be followed for 6 months after surgery to determine time until return to normal life and occurrence of any complication related to the use of cryo-analgesia. Numeric Rating Scale (NRS), CALI9, YAPFAQ will be measured at fixed times to determine pain intensity and limitations due to pain. Risk factors for prolonged pain and time needed until achieving discharge criteria from hospital will be reported.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing pectus excavatum repair with NUSS technique
- •aged 12 years or above12
- •informed consent signed for cryoanalgesia
排除标准
- •Age of 11 years or below
- •Refuse to receive cryoanalgesia or epidural catheter as primary pain relief
- •Any contraindication to cryoanalgesia
- •Difficult follow-up for geographical reasons and/or impossibility by the patient to understand how to perform self-measurements
研究组 & 干预措施
Standard of care
Epidural analgesia
Cryoanalgesia
Cryoanalgesia
干预措施: Cryoanalgesia (Device)
结局指标
主要结局
Quality of Life by PedsQL 23 items
时间窗: Two weeks after surgery
Quality of life after surgery
次要结局
- YAPFAQ (Youth Acute Pain Functional Ability Questionnaire)(One week after surgery)
- Thoracic hypo-aesthesia(Six months after surgery)
- Pain by VAS(1-14 days after surgery)
研究者
Nicola Disma, MD
Head of Research and Innovation Unit
Istituto Giannina Gaslini