跳至主要内容
临床试验/NCT02925364
NCT02925364终止不适用

Functional and Anatomical MRI of the Spinal Cord and Perispinal Tissues 6 Months After Cardiac Surgery With Standard vs. Gradual Sternal Retraction: Implications for Chronic Post-surgical Pain

Dr. Tarit Saha1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
17
试验地点
1
主要终点
functional MRI (fMRI)

研究概览

简要总结

The current study is an amendment to a previously approved blinded randomized controlled trial (NCT02697812) which examines the rate at which the sternal retraction maneuver is performed during cardiac surgery (standard over 30 seconds versus. gradual over 15 minutes) and examines the incidence of chronic post-sternotomy pain 6 months following surgery.

Patients enrolled in the parent study will be identified at the 6 month follow-up and recruited in terms of whether they report chest pain. A total of 30 participants will be recruited (15 with and 15 with no pain) to undergo a single MRI session in which functional MRI will be done on the brain stem and spinal cord and anatomical MRI images will be collected for specific chest and neck structures. This will indicate whether there are long-term differences in pain processing and/or physical damage to neck and chest structures in those with and without chronic pain 6 months following coronary artery bypass graft surgery. All functional and anatomical MRI images will be reviewed and interpreted with study personnel blinded to whether the patient is reporting pain or no pain at their 6 month follow-up interview.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective Primary Coronary Artery Bypass Surgery
  • Understanding and provision of written informed consent
  • Age > 18 and < 75
  • ASA class I, II or II

排除标准

  • Any combined or redo cardiac procedure
  • Current alcohol or substance abuse
  • Pre-existing chronic pain requiring chronic analgesic use
  • Rest pain in proposed surgical area at baseline, preoperatively
  • Chronic Steroid use
  • Inability to perform post-operative assessments

结局指标

主要结局

functional MRI (fMRI)

时间窗: 6 months postoperatively

functional MRI of brain stem \& spinal cord

次要结局

  • anatomical MRI(6 months postoperatively)

研究者

发起方
Dr. Tarit Saha
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Tarit Saha

Director, cardiac anesthesia group

Queen's University

研究点 (1)

Loading locations...

相似试验