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临床试验/NCT02697812
NCT02697812已完成不适用

Does the Speed of Sternal Retraction During Coronary Artery Bypass Graft Surgery Affect Postoperative Pain Outcomes: A Randomized Controlled Trial

Dr. Tarit Saha2 个研究点 分布在 1 个国家目标入组 326 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
326
试验地点
2
主要终点
Incidence of chronic post-sternotomy pain

研究概览

简要总结

In North America, almost ½ million people undergo coronary artery bypass graft surgery annually and over 1/3rd develop chronic chest pain. The current study will randomize cardiac surgery patients to undergo slow sternal retraction for heart exposure (over 15 min.) versus standard-of-care (sternal opening over 30 seconds) and examine the incidence and severity of chronic post-sternotomy pain (CPSP) and quality-of life 3, 6 and 12 months post-operatively. The severity of acute post-operative pain will also be measured. Increased retraction time reduces forces required, which should translate to reduced nerve/tissue damage. If effective, this simple change in practice could be readily implemented with a major impact for patients and the health care system overall.

详细描述

The overall objective of the current investigation is to determine whether increasing the time to sternal retraction to 15 minutes (from the standard ~30 sec), will result in reduced acute and chronic post-sternotomy pain and an improved quality of life. The hypothesis here is that increased time to sternal retraction will result in: reduced required force, less physical trauma, less inflammation, and less nerve damage. Specifically, the hypothesis is that slow steady sternal retraction (occurring over 15 minutes) will 1) reduce the incidence of CPSP by 40% 2) reduce the severity of acute postoperative pain by at least 20-30% and 3) significantly improve quality of life 6 months postoperatively.

The current investigation will be a prospective blinded, randomized, controlled trial. Following institutional ethics approval and signed consent, eligible patients scheduled for elective coronary artery bypass graft surgery will be randomly assigned (stratified by gender and surgeon to ensure equality between groups) either to the Standard group (in which sternal retraction occurs over ~30s) or the Slow group in which sternal retraction occurs over 15 minutes. Patients and research personnel performing the postoperative assessments will remain blinded to group assignment until conclusion of the investigation. All other intra-operative variables will be performed as per standard practice by the cardiac surgeons at Kingston General Hospital. The extent of sternal retraction will be to the surgeon's discretion to enable appropriate exposure of the heart to allow safe conduct of the operation but it will be recorded in all cases.

The primary outcome measure will be the incidence of chronic post-sternotomy chest pain 6 months following CABG with median sternotomy. However, we will also measure the incidence of CPSP at 3 and 12 months to determine the trajectory. Secondary outcomes will include: Pain intensity (numeric rating scale-NRS) of chest pain (which differs from preoperative) at rest and while coughing daily while in hospital until discharge and at 1 week postoperatively. Analgesic consumption (morphine equivalents) daily while in hospital until discharge, 1 week post-operatively and then at 3, 6, and 12 months postoperatively. Intra-operative data will include time from initiation to full retraction, latency from full retraction to sternal closure, width of sternal opening at full retraction. Pain quality, quality of life, and pain interference with daily function at 3, 6 and 12 months post-operatively. All assessments following discharge from the hospital will be via telephone calls from a research nurse blinded to randomization assignment. In-hospital assessments will also be done by a research nurse blinded to group assignment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

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 coronary artery bypass graft surgery
  • understand written informed consent
  • ASA I,II or III

排除标准

  • revision cardiac surgery
  • current alcohol/substance abuse
  • pre-existing chronic pain requiring chronic analgesic use
  • rest pain in proposed surgical area preoperatively
  • chronic steroid use
  • inability to perform postoperative assessments

结局指标

主要结局

Incidence of chronic post-sternotomy pain

时间窗: 6 months postoperatively

incidence of chronic post-sternotomy pain 6 months following coronary artery bypass graft surgery

次要结局

  • severity of chronic postoperative pain(3 months. 6 months, 1 year)
  • Incidence of chronic post-sternotomy pain(3 and 12 months postoperatively)
  • quality of life with the Modified Brief Pain Inventory (BPI)(3, 6, 12 months postoperatively)
  • pain quality with the McGill Pain Questionnaire-short form (MPQ-SF)(3, 6 and 12 months postoperatively)
  • analgesic consumption(daily while an inpatient up to 1 week postoperatively, 1 week postoperatively, 3, 6 and 12 months postoperatively)
  • severity of acute postoperative pain at rest and with coughing(daily while an inpatient up to 1 week postoperatively)
  • pain quality with the Douleur Neuropathique Questionnaire (DN4)(3, 6 and 12 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

Principal Investigator

Queen's University

研究点 (2)

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