Effect of Diclofenac Versus Tramadol on fracture healing following intramedullary Nailing of tibia:A Randomized control trial study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Fracture healing assessed both clinically (absence of tenderness or pain on weight bearing) and radiologically (bridging callus seen in 4 cortices on AP and lateral views).
研究概览
简要总结
A Randmoized control Trial study In which Patients with tibial fractures are screened based on inclusion and exclusion criteria followed by informed consent will obtained and participants will be randomized into two groups Group A Diclofenac and Group B Tramadol.
All patients underwent tibia nailing surgery followed by postoperative analgesia as per group allocation Clinical VAS scores and radiological X rays at 4 6 12 and 24 weeks assessments are conducted to monitor pain relief and fracture healing.
The two groups are compared for pain control efficacy as well as time to radiological union and incidence of complications to determine the impact of Diclofenac versus Tramadol on postoperative fracture healing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Fracture type Closed fractures As well as Gustillo Anderson Classification type 1 Open Fracture.
- •Patients undergoing intramedullary nailing as the primary treatment.
- •Patients who will provide informed written consent.
排除标准
- •Patient with pathological fractures as well as gustillo Anderson classification type 2,3 open fractures.
- •Patient with comorbid conditions such as hepatic or gastrointestinal disorders that will contraindicated diclofenac use.
- •Known hypersensitivity or intolerance to either tramadol or Diclofenac.
- •History of chronic use of Diclofenac, opioids within the last 3 months.
- •Patients unlikely to adhere to follow-up protocol or have significant psychiatric illness.
- •Female patients who are pregnant or breastfeeding.
结局指标
主要结局
Fracture healing assessed both clinically (absence of tenderness or pain on weight bearing) and radiologically (bridging callus seen in 4 cortices on AP and lateral views).
时间窗: 4 Weekly radiological assessment
次要结局
- 1 Time taken to achieve union incidence of delayed union(2 Time taken to achieve union incidence of nonunion or no progression)
研究者
Dr Niranjan Atpadkar
Chhattisgarh Institute of Medical Sciences,Bilaspur