Analgesic Efficacy of Pre-operative Dose of Ketorolac And Gabapentin in Patients Undergoing Unilateral Total Knee Arthroplasty A Randomized Double Blinded Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- evaluate the analgesic efficacy of a pre-operative dose of ketorolac and gabapentin in reducing post-operative pain scores in patients undergoing TKA.
研究概览
简要总结
Evaluation of the analgesic efficacy of a pre-operative dose of ketorolac and gabapentin in reducing post-operative pain scores in patients undergoing TKA
详细描述
Elective total knee arthroplasty (TKA) is the gold standard for management of arthritis-associated pain and disability in osteoarthritis patients who have failed non-operative treatment modalitiesFollowing TKA, patients experience severe pain mediated by multiple pathways Painful stimuli to the body are detected by the free endings of peripheral nerves called nociceptors. Pre-emptive analgesia is analgesia given before the onset of painful stimuli to prevent central sensitization of nervous system to subsequent stimuli that could increase pain Studies have shown that pre-emptive analgesia reduce immediate postoperative pain and also prevent the development of chronic pain by decreasing altered sensory processing . Multimodal analgesia is the rational approach to pain management since no single analgesia targets all types of pain Multimodal analgesia, which is the use of at least 2 agents with differing mechanisms for pain control, has been shown to reduce hospital length of stay by 1.2 days and rehabilitation length of stay by 10 to 13 days compared with traditional postoperative analgesia. Ketorolac is a non-steroidal anti-inflammatory drug (NSAID). It is a cost-effective non selective cox inhibitor it inhibits prostaglandin biosynthesis. It is a potent analgesic with moderate anti-inflammatory.it inhibits platelet aggregation and increases bleeding time GABA analogues like Gabapentin is a structural analogue of gamma amino butyric acid, which was introduced in 1994 as an antiepileptic drug, particularly for partial seizures These drugs supress the hyper excitability of dorsal horn neurons caused due to tissue damage. They are also known to bind to the alpha 2 - delta subunit of voltage gated calcium channels and they have anxiolytic effect In this study we will assess the analgesic efficacy of pre-operative dose of combined ketorolac and Gabapentin in patients undergoing TKA.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients Undergoing Unilateral Total Knee Replacement from 40 years old to 80 years old
排除标准
- •Rheumatoid Arthritis History of Renal impairment Patients refused to be enrolled in the study
研究组 & 干预措施
Experimental group
Experimental group will receive single dose of gabapentin 800 mg capsule and ketorolac 30 mg Ampule, one hour prior to administration of spinal anesthesia
干预措施: Ketorolac Tromethamine 30 MG/ML Prefilled Syringe (Drug)
Experimental group
Experimental group will receive single dose of gabapentin 800 mg capsule and ketorolac 30 mg Ampule, one hour prior to administration of spinal anesthesia
干预措施: Gabapentin (Drug)
control group
control group will receive normal saline ampule and empty capsule one hour prior to administration of spinal anesthesia
干预措施: Empty Medication Capsules (Drug)
结局指标
主要结局
evaluate the analgesic efficacy of a pre-operative dose of ketorolac and gabapentin in reducing post-operative pain scores in patients undergoing TKA.
时间窗: during the first 24 hours post-operatively
asses pain postoperatively at 6,12,24 hours using VAS score
次要结局
- assess the impact of pre-operative ketorolac and gabapentin on post-operative opioid consumption(during the first 24 hours post-operatively)
- investigate the safety profile of pre-operative ketorolac and gabapentin(during the first 24 hours post-operatively)
- evaluate the effect of pre-operative ketorolac and gabapentin on functional recovery(during the month after surgery)
研究者
Nour Shaaban Abdel-Aleem Mohamed
Resident
Assiut University
