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