Assessment of the effect of DEXMEDETOMIDINE as an adjuvant for ROPIVACAINE in suprainguinal facia iliaca compartment block for femur fixation surgeries.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- To determine the time to first rescue analgesia.
研究概览
简要总结
Effective perioperative pain management is the cornerstone of a successful orthopaedic surgery, particularly in femur fixation surgeries, which are associated with significant postoperative pain. Regional anaesthetic techniques such as the suprainguinal facia iliaca compartment block(FICB) have gained popularity due to their ability to provide targeted anaelgesia while mimimising systemic side effects.
Among local anaesthetics, ROPIVACAINE is widely used for its favourable safety profile and prolonged duration of action. However the need for improving the anaelgesic efficacy and duration has led to the use of adjuvants.
DEXMEDETOMIDINE, a selective alpha 2 adrenergic agonist has emerged as a promising adjuvant in regional anaesthesia due to its sedative, anaelgesic and opioid sparing properties.
The suprainguinal approach to the FICB is a better alternative than the infrainguinal approach with ultrasound guidance reducing the risk of complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society of Anaesthesiologists (ASA)Status – 1 to 3 Patients posted for femur fixation surgery.
排除标准
- •Refusal to participate.
- •BMI more than 45Kg/m
- •History of heart failure/ renal failure/ liver failure.
- •Contraindication for spinal anaesthesia.
- •Allergy to local anaesthetics.
- •Prior surgery in the inguinal or suprainguinal area.
- •On chronic opioid therapy.
- •Prior history of myocardial infarction.
结局指标
主要结局
To determine the time to first rescue analgesia.
时间窗: 0 hours to 24 hours
次要结局
- 1. VAS scores on arrival to PACU and every 4 hours for 24 hours.(2. Presence or absence of quadriceps weakness during mobilisation.)
研究者
Dr Mrinal Kaushik
Sri Ramachandra Institute of Higher Education and Research