Impact of Dexmedetomidine Add to Intra-articular Bupivacaine for Post Operative Analgesia After Knee Arthroscopic Surgery
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change on the visual analog scale (VAS) for pain (0 = no pain to 100 = the maximum pain )to assessment the duration of analgesia following the surgery
研究概览
简要总结
The aim of this study to compare the analgesic effects of intraarticular dexmedetomidine added to bupivacaine with those of bupivacaine alone after knee arthroscopy
详细描述
prospective double-blind study perform on 75 patients candidates for anterior cruciate ligament (ACL) reconstruction by knee arthroscopy refer to the clinic of Al Azhar University Hospital, Assiut, Egypt, to evaluate the effect of adding dexmedetomidine to intra articular bupivacaine injection on postoperative pain after knee arthroscopy.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-II patients
- •Either sex
- •Aged 18-65 years
- •Candidates for anterior cruciate ligament (ACL) reconstruction by knee arthroscopy
排除标准
- •the patients with kidney failure, liver failure, valvular and ischemic heart disease , high blood pressure, diabetes, history of infection and malignancy.
- •history of coagulation diseases, and history of drug allergies to used drugs.
- •those who consumed NSAIDs and analgesics 24 h before surgery were excluded from the study.
研究组 & 干预措施
group of control (C)
receive 18 ml of normal saline only and serve as the control group.the normal saline will injected in the knee joint by the surgeon through the arthroscope after completing the procedure
干预措施: Normal Saline (Placebo) (Drug)
groups of Bupivacaine (B)
The 18ml 0.25% bupivacaine will injected intra articular in the knee joint by the surgeon through the arthroscope after completing the procedure
干预措施: Bupivacaine 0.25% (Drug)
groups of Bupivacaine (B)
The 18ml 0.25% bupivacaine will injected intra articular in the knee joint by the surgeon through the arthroscope after completing the procedure
干预措施: Dexmedetomidine (Drug)
groups of dexmedetomidine (D)
Dexmedetomidine 1 μg/kg will injected intra articular in the knee joint by the surgeon through the arthroscope after completing the procedure.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Change on the visual analog scale (VAS) for pain (0 = no pain to 100 = the maximum pain )to assessment the duration of analgesia following the surgery
时间窗: post operative at 30 minute, 1 hour, 2 hour, 4 hour, 6 hour, 12 hour, and 24 hour .
Change on the visual analog scale (VAS) for pain (0 = no pain to 100 = the maximum pain) to assessment the duration of analgesia following intra articular injection of Bupivacaine and Dexmedetomidine after knee arthroscopy
次要结局
- Total meperidine consumption . Meperidine will be used intravenously if the visual analog scale ( VAS) score was >50 to control postoperative pain.(The total dose of meperidine given between the study groups during the first 24 hour( post operative at 30 minute, 1 hour, 2 hour, 4 hour, 6 hour, 12 hour, and 24 hour),will be recorded.)
研究者
Mohamed Ali Mahmoud
Lecturer of anesthesia, intensive care and pain management
Al-Azhar University