Pilot Study Evaluating Neuro-Imaging Correlates of Epigenetic Finding in Prediction of Chronic Postsurgical Pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Chronic post-surgical pain; Unabbreviated scale title "Chronic post-surgical pain scores"
研究概览
简要总结
This pilot research study is being performed to learn more about pain and look at how pain changes brain chemistry and function. The research team would like to learn new information to better control chronic pain after surgery. This information collected in this research will be used to plan possible future visits. Participants in this study are being asked to participate because they are scheduled for an upcoming surgery. The research team would like to observe them before and after their surgery.
详细描述
This study is a pilot feasibility study in 30 healthy, preoperative children and young adults undergoing major surgery with high risk for chronic post-surgical pain (CPSP) to characterize the brain metabolite status of the Anterior cingulate cortices (ACC) and insula in pre-surgical adolescents and to understand the relationship between metabolite levels and CPSP. The investigators will also examine whether neurochemical tone in these regions is related to resting state functional connectivity with other brain regions. Correlations between differentially methylated CpG sites in genes enriching gamma aminobutyric acid (GABA) and Dopamine-DARPP-32 pathways and Glu/GABA levels in insula/ACC will be analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or female aged ≥ 8 yrs of age
- •English speaking;
- •Healthy (Defined as American Society of Anesthesiologists Physical Status 1 or 2)
- •Ability to provide assent/consent/parent permission.
- •Scheduled to undergo chest surgery (thoracotomy, thoracoscopy, Nuss procedure, pectus surgery, mastectomy), spine surgery, amputation, hernia repair or hip/knee replacement.
排除标准
- •History of chronic pain conditions including migraines
- •Use of opioids chronically or for major surgery within the 6 months prior to enrollment
- •Severe obesity (BMI>35 kg/m2)
- •Taking no more than two concomitant medications known to induce or inhibit CYP2D6 activity, including paroxetine, fluoxetine, cimetidine, and duloxetine or other medications used to treat attention deficit hyperactivity disorder (medications containing amphetamine or methylphenidate).
- •Use of hormonal contraceptives
- •Use of medications that may alter pain sensitivity (e.g. gabapentin,/pregabalin amitryptiline/other antidepressants, clonidine).
- •Active or history of renal/liver problems or congenital cardiac disease
- •Diagnosed developmental delay
- •Pregnant or lactating females
- •Any skin condition that prevents cuff application
- •History of seizures
- •Claustrophobia
- •Metallic implants/orthodontics/braces or other MRI exclusion (MRI safety screening will be conducted prior to enrollment and prior to each MRI scan)
结局指标
主要结局
Chronic post-surgical pain; Unabbreviated scale title "Chronic post-surgical pain scores"
时间窗: 2-6 months after surgery
Pain scores over prior 2 weeks reported 2-6 months after surgery; minimum value = 0, maximum value = 10; higher score means more severe pain
次要结局
- Resting state connectivity(1 - 8 weeks before surgery)
- Correlation of DNAm of specified gene regions with outcomes(1-8 weeks before surgery or day of surgery)
- Evoked pressure pain measures; Unabbreviated scale title "Evoked pressure pain measures"(1-2 weeks after surgery)