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临床试验/CTRI/2019/02/017660
CTRI/2019/02/017660已完成Unknown

Effect of pregabalin versus duloxetine on analgesic requirement following lower limb trauma surgeries: a randomized, clinical trial

Government Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年1月3日最近更新:

试验速览

阶段
Unknown
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Time to first recue analgesia

研究概览

简要总结

Lower limb trauma comprises a significant portion of trauma surgeries and the most common complaint is pain.The available modalities in multimodal pain management include pharmacological, peripheral nerve blocks and neuraxial analgesia. However, opioids have undesirable side effects like respiratory depression, nausea/vomiting, constipation, sedation and sometimes physical dependence. Opioids also cause gastrointestinal hemorrhage, renal dysfunction and decreased hemostasis. Gabapentinoids is a class of anticonvulsants used in pain management due to good postoperative analgesia, safety profile, better tolerance and fewer drug interactions. Gabapentin and pregabalin are the gabapentioids which are used. Trauma also causes nerve damage which results in posttraumatic neuropathic pain. Thus, neuropathic pain is an element of trauma. Duloxetine is an antidepressant which possesses analgesic effect.There are encouraging results of duloxetine and pregabalin in literature but it is scant in comparison of analgesic efficacy of pregabalin versus duloxetine for postoperative pain relief in trauma patients undergoing lower limb surgeries. We hypothesize that difference exists between response rates in terms of rescue analgesia and postoperative pain relief with the use of either pregabalin or duloxetine. Hence, this trial is planned to compare the response rates of rescue analgesic requirement with perioperative pregabalin or duloxetine in trauma patients undergoing lower limb surgeries.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • American Society of Anesthesiologists (ASA) physical status I and II Surgery of unilateral tibia or femur following trauma less than one month.

排除标准

  • Patients having head injury and/or polytrauma including bilateral fractures.
  • Patients having coagulopathy.
  • Patients with Patient Health questionnaire-9 (PHQ-9) and Generalised Anxiety Disorder-7 (GAD-7) >
  • Patients taking medications for chronic pain.
  • Patients with contraindications to pregabalin, duloxetine and diclofenac.
  • Pregnant and lactating women.
  • Patients not able to understand VAS.
  • Patients having history of substance abuse.

结局指标

主要结局

Time to first recue analgesia

时间窗: Time When patient takes first recue analgesia

次要结局

  • 1. Total cumulative rescue analgesia(2. VAS at rest and VAS on movement)

研究者

发起方
Government Medical College and Hospital
申办方类型
Government medical college

研究点 (1)

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