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临床试验/NCT04085588
NCT04085588已完成不适用

Low Dose Ketamine Infusion for Postoperative Analgesia After Total Knee Arthroplasty: Optimum Dose to Reduce Morphine Consumption

Mustafa Kemal University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2019年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
1
主要终点
Optimal dose of Ketamine to reduce morphine consumption

研究概览

简要总结

This study evaluates continous infusion of low-dose ketamine during intraoperative and postoperative periods at three different doses to provide postoperative analgesia in total knee arthroplasty cases. Patients enrolled randomly into one of 2, 4, 6 μg / kg / min perioperative ketamine groups. All groups were given spinal anesthesia and intravenous patient controlled anesthesia. Ketamine was started when sensorial block reached T10 dermatome level before the skin incision. By the end of the operation, in all groups, ketamine infusions were reduced by half doses. Intravenous patient-controlled analgesia device was set to 2 mg bolus morphine with no basal infusion for 48 hours during the postoperative period.

详细描述

Multimodal analgesia, which involves the administration of two or more analgesic agents targeting different levels of pain pathways, is used to improve pain control while also to reduce opioid use and related side effects. Pain can be treated at various neurophysiological levels, including peripheral, spinal and cortical targets. One of the agents used in the multimodal analgesia technique is ketamine.

Ketamine acts on the central nervous system (CNS) and has local anesthetic effect. Ketamine is an N-methyl D-Aspartate (NMDA) receptor antagonist, which appears to be the main mechanism of anesthetic and analgesic action at CNS and spinal cord receptors. Other mechanisms of action of ketamine include the interaction with opioid receptors, particularly mu and kappa receptors. Another effect is that it has local anesthetic effect in high doses. Studies have shown that ketamine is an effective agent in the treatment of postoperative pain. Continuous infusion of low-dose ketamine after total knee arthroplasty significantly reduced morphine consumption, and provided early rehabilitation without increasing side effects. However, when these studies are considered, there is no information about the optimal dose of ketamine that reduces opioid consumption at the highest level.

In our study, continuous infusion of low-dose ketamine at different doses was planned to provide postoperative analgesia. Therefore, our first aim in this study was to find out the optimal dose that reduced morphine consumption for postoperative analgesia after TKA with continuous ketamine infusion at different doses. The secondary objectives are to evaluate early and late period pain, side effects, length of hospital stay, patient satisfaction, and recovery.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • ASA I-Ⅲ female patients scheduled for unilateral total knee arthroplasty

排除标准

  • Patients younger than 18 years of age
  • ASA Ⅳ and above patients
  • Having previous knee surgery on the same side
  • Patients with allergies to drugs to be used in the study
  • Contraindication for spinal anesthesia
  • Body mass index 40 kg / m2 and above patients
  • Opioid tolerance
  • Patients with neurological or psychiatric disorders
  • Patients who do not have the ability to use patient controlled analgesia device

结局指标

主要结局

Optimal dose of Ketamine to reduce morphine consumption

时间窗: 48 hours from the operation

Ketamine infusions 2μg 4μg and 6μg / kg / min will be started preoperatively in group 1, 2 and 3 respectively when sensory block level reaches T10 after spinal anesthesia, and they will be reduced by half by the end of the operation. Ketamine infusion will be continued for 48 hours postoperatively.

次要结局

  • Early and late period pain(3 months from the operation)
  • side effects,(3 months)
  • length of hospital stay(3 months)
  • patient satisfaction(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Selim Turhanoglu

Professor Doctor

Mustafa Kemal University

研究点 (1)

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