Improved Rehabilitation After Spinal Surgery in Adolescents: Prospective Observational Epidemiological Study of a Protocol Without Opioid
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence of chronic postsurgical pain after surgery in the adolescent cohort included in the study RACAROFA
研究概览
简要总结
Impact of the OFA technique on postoperative recovery from adolescent spine surgery and the incidence of chronic postoperative pain.
详细描述
RACAROFA is an observational, prospective study based on the hypothesis that the OFA technique effectively improves the long-term postoperative rehabilitation of adolescents and reduces the incidence of CPSP. A prospective French multicentre study on this topic is currently not feasible, as other multicentre studies (pain monitoring by the ANI, blood saving strategy) would interfere with potential recruitment.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patent with idiopathic or secondary surgical scoliosis
- •Management by the paediatric anaesthesia team at the Mother and Child - Hospital of the University Hospital of Nantes
- •Non-opposition to inclusion in the study collected orally from the patient and parents
- •Satisfying oral and written comprehension of the French language, without interpreter
- •Ability to participate in a telephone interview
排除标准
- •Patient that does not understand French correctly
- •Patient unable to express himself/herself correctly in French
- •Patient with a non-scoliotic surgical spinal pathology
- •Refusal to participate in the study
- •Absence of a record of non-opposition to participation in the study from the patient and his or her parents
- •Cerebral palsy or any other condition that does not allow participation in a telephone interview without particular difficulty.
结局指标
主要结局
Incidence of chronic postsurgical pain after surgery in the adolescent cohort included in the study RACAROFA
时间窗: Sixth months after surgery
Pain at the surgical site, rated at more than 3 on a numerical scale graduated from 0 (no pain) to 10 (maximum pain) during a telephone interview.
次要结局
- Occurence of a postoperative opioid-related adverse event(Within the first 48 hours after extubation)
- Postoperative opioid consumption(Within the 2 first weeks postsurgery)
- Level of preoperative and postoperative catastrophism in the adolescent cohort included in the study RACAROFA.(sixth months after surgery)
- Length of stay in the hospital(Within the first 2 weeks postsurgery)
- Incidence of postoperative neuropathic pain in the adolescent cohort included in the study RACAROFA.(Six months after surgery)
- Level of preoperative quality of life(Three month after surgery)
- Level of preoperative quality of life: SRS-30 score(Sixth month after surgery)
- Postoperative rehabilitation(Within the first 2 weeks postsurgery)
- Postoperative antalgics consumption other than opioid(Within the first 2 weeks postsurgery)
- Incidence of preoperative pain in the adolescent cohort included in the study RACAROFA.(Two weeks before surgery)
- Level of preoperative quality of life.(Two weeks before surgery)
- Level of preoperative and postoperative anxiety in the adolescent cohort included in the study RACAROFA(sixth months after surgery)
- Level of preoperative and postoperative catastrophism in one of the parents of each adolescent included in the study RACAROFA.(sixth months after surgery)