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临床试验/NCT07047040
NCT07047040尚未招募2 期

Analgesic Efficacy of Pre-operative Dose of Ketorolac And Gabapentin in Patients Undergoing Unilateral Total Knee Arthroplasty A Randomized Double Blinded Controlled Trial

Assiut University1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2025年8月15日最近更新:
适应症
干预措施

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

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

Active Comparator

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

Active Comparator

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

Placebo Comparator

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

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

Nour Shaaban Abdel-Aleem Mohamed

Resident

Assiut University

研究点 (1)

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