Cryoanalgesia in Combination With the Novel Prehabilitation Program Back on Feet Are the Essential Parts of Enhanced Recovery Protocol in the Minimal Invasive Modyfied Nuss Procedure of Children With Funnel Chest Deformation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The worse pain occurence during first 24 hours after operation
研究概览
简要总结
This Study study compared standard therapy (multimodal and regional analgesia) versus a novel approach (Cryoanalgesia combined with bilateral erector spine plane block and multimodal analgesia) in subjects undergoing minimal invasive modyfied Nuss procedure (thoracoscopy).
详细描述
Funnel chest deformation is a great challenge for therapeutic teams due to severe pain in the postoperative period as well as chronic pain. The use of many analgesic drugs, including opioids, is associated with adverse side effects, difficulties with rehabilitation, an increased risk of complications, prolonged hospitalisation, and the cost of the procedure. Cryoanalgesia as a part of multimodal analgesia along with the education and prehabilitation of the patient according to the novel original educational - training application 'Back on Feet' as well as the interdisciplinary care in accordance with the enhanced recovery after surgery (ERAS) protocol, which has a real impact on the optimisation of perioperative care.
This Before - After Study is a single institution pilot study designed to compare standard therapy (control group: regional analgesia: intrapleural or bilateral erector spine plane block) versus a novel approach (interventional group: Cryoanalgesia combined with bilateral single shot erector spine plane block) to address the need for better management of acute and long-term pain in the pediatric population diagnosed with funnel-chest and treated using the modyfied Nuss method.
First group received a standard care according to Polish guidelines. The data of control group analysed and the interdisciplinary team work protocol will be introduced to the interventional group. The interventional group was prepared according to prehabilitation with the 'Back on feet' application and perioperative ERAS protocols. The patients of interventional group received intraoperative cryoanalgesia using the Cryo-S Painless device (Metrum - Cryoflex Polska Limited) as an additional procedure to multimodal analgesia. This is the first time that the cryoanalgesia procedure was performed in children in Poland.
The aims of the study were the assessment the effectiveness of cryoanalgesia as a method of acute and long-term pain control, safety of the method and the impact of preoperative preparation according to the 'Back on Feet' program introduced as a part of ERAS protocol.
Specific Aim 1: To determine if, compared with current analgesia, the addition of cryoanalgesia decreases the incidence and severity of post-surgical pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 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 modyfied minimal invasive thoracoscopic NUSS technique
- •aged 10 years or above 10
- •informed consent signed for cryoanalgesia
排除标准
- •Age of 9 years or below
- •Refuse to receive cryoanalgesia or regional analgesia 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
结局指标
主要结局
The worse pain occurence during first 24 hours after operation
时间窗: up to 24 hours after operation
Numeric pain score. Range from 0 to 10.
次要结局
- Assessment of sleeping quality(Postoperative days 1, 2, 3, 4, 5 ,6)
- Total narcotic use post-operation(0-6 postoperative days)
- Postoperative nausea and vomiting (PONV) occurence(Postoperative days 1, 2, 3, 4, 5 ,6)
- Analgesic consumption post operation(Postoperative days 0, 1, 2, 3, 4, 5,6, as well as months 1 and 3)
- Residual wound or chest pain occurence(Postoperative months 1, 3)
- Duration of hospitalization(estimated 1 week)
- Thoracic hypo-aesthesia occurence(up to 24 hours after operation)
- Cost Analysis(estimated 1 week)
研究者
Sławomir Zacha
Principal Investigator
Pomeranian Medical University Szczecin
