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临床试验/NCT02752477
NCT02752477Unknown3 期

Efficacy of Opioid-free Anesthesia in Reducing Postoperative Pain in Chronic Pain Patients Undergoing Spinal Surgery: A Pilot Study

Ben Lim1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年8月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
发起方
入组人数
30
试验地点
1
主要终点
Quantified opioid-consumption

研究概览

简要总结

The objective of this trial is to determine whether an opioid-free general anesthetic (OFA) technique utilizing ketamine, dexmedetomidine, and lidocaine infusions can help reduce postoperative pain in opiate-dependent chronic pain patients (CPPs) undergoing spine surgery when compared with traditional opioid-containing techniques. It is expected that this OFA regimen will have a measurable reduction on postoperative opioid consumption and pain scores in CPPs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Chronic pain > 6 months, opiate-using patients scheduled for thoracic or lumbar spinal surgery

排除标准

  • Pregnant or breastfeeding women, significant hepatic, renal or cardiac disease, allergy to any of the study drugs, inability to consent, respond to pain assessments or use the patient controlled analgesia device

研究组 & 干预措施

Opioid-free anesthetic (OFA) group

Experimental

干预措施: Opioid-free general anesthetic (Drug)

Traditional Anesthesia (TA) group

Active Comparator

干预措施: Traditional general anesthetic (Drug)

结局指标

主要结局

Quantified opioid-consumption

时间窗: 48 hours following surgery

次要结局

  • Time of stay in post-anesthetic care unit (PACU)(up to 5 hours following surgery)
  • Visual analogue scale (VAS) pain scores(48 hours following surgery)
  • Incidence of adverse events(48 hours following surgery)

研究者

发起方
Ben Lim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ben Lim

Anesthesiologist

University of Saskatchewan

研究点 (1)

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