Genetic, Epigenetic, Psychosocial, and Biological Determinants of Post-surgical Pain After Pectus or Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Pain score trajectory
研究概览
简要总结
This will be a prospective study to determine the association between specific genotypes, epigenetics, behavioral, social and biological factors, with the phenotypes, defined by pain perception, postoperative pain, analgesic effects, side effects to perioperative analgesics, chronic postoperative pain, and gene expression in patients following pectus excavatum repair.
详细描述
This study will be a clinical prospective study. It is observational for all aims except with regard to the Meditation Intervention, which will be limited to 100 pectus and 100 spine participants (randomized to 50/50 in each arm). We will recruit 600 qualifying participants over the study period to acquire the necessary data to derive a predictive model matching phenotype to genotype. This study will not interfere with the standard anesthetic or perioperative care except for blood sampling from an indwelling line, and the use of additional integrative health procedures (focused-attention meditation guidance, as well as routine massage and breathing techniques) for the randomized meditation group. Research staff will administer psychosocial and somatosensory assessments, as well as record relevant data from participant's medical records. Integrative health will assist in teaching focused-attention meditation to the randomized meditation participants in the preoperative phase. Actigraphy devices will be provided to all participants, and MUSETM to those in the randomized meditation group. The pain team, in accordance with the Pectus Pain Management Protocol, will direct perioperative pain management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 8 years of age through adulthood
- •Diagnosis of pectus excavatum or adolescent idiopathic scoliosis
- •Scheduled for endoscopic pectus excavatum repair or spine fusion
排除标准
- •History of or active renal or liver disease
- •Major surgery requiring opioids in the last 5 years
- •Severe respiratory problems (such as obstructive sleep apnea, cystic fibrosis, pulmonary fibrosis, or pneumonia within the last month)
- •Cardiac conditions including, but not limited to, cyanotic heart disease, hypoplastic left ventricle, arrhythmia, hypertension with ongoing treatment, Kawasaki disease, or cardiomyopathies. Participants with asymptomatic valvular lesions or defects may be included
- •History of seizures currently treated on medication (participants off medication and seizure free for greater than one year may be included)
- •Taking no more than two concomitant medications known to induce or inhibit CYP2D6 activity, including paroxetine, fluoxetine, cimetidine, and duloxetine
- •Needing postoperative ventilation or intraoperative cardiac bypass standby
- •Pregnant or breastfeeding females
- •Non-English speaking
- •Definite developmental delay
结局指标
主要结局
Pain score trajectory
时间窗: 1 year
Pain scores will be collected preoperatively through 1 year postoperatively
Changes in self-reported psychosocial scores (including anxiety, pain, coping, physical limitation, etc.)
时间窗: 1 year
Psychosocial measures will be collected preoperatively through 1 year postoperatively
Changes in evoked response potentials (ERPs) during meditation and experimental pain tasks
时间窗: 8 weeks
Brain activity will be assessed preoperatively and postoperatively
Changes in heart rate variability
时间窗: 8 weeks
Heart rate variability will be assessed preoperatively and postoperatively
Incidence of side-effect measures
时间窗: 72 hours postoperatively
Incidences of respiratory depression, sedation, postoperative nausea and vomiting will be collected during the recovery phase
Changes in mean amplitude values for lower, upper, and entire alpha frequency bands by group (intervention/no intervention) and time (pre-surgery/post-surgery)
时间窗: 8 weeks
Brain activity will be assessed preoperatively and postoperatively
Changes in sleep efficiency/duration (actigraphy) and self-reported sleep quality
时间窗: 8 weeks
Sleep efficiency and quality will be assessed preoperatively and postoperatively
次要结局
- Changes in pressure pain threshold, conditioned pain modulation, tactile discrimination, and temporal summation index(8 weeks)