Dexmedetomidine and Bupivacaine versus Bupivacaine Alone in Ultrasound Guided PENG block in proximal Femoral Fractures: a Randomized Comparative study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Duration of analgesia
研究概览
简要总结
Anaesthetists have sought strategies to extend the benefits of single-shot
peripheral nerve blocks beyond the duration of commonly available
local anaesthetics (LA).Dexmedetomidine, an alpha-2 agonist, has been
proposed as a safe and effective adjunct capable of extending the
duration of single-shot block.Hyperpolarization-activated cation
currents normally bring neurons back to the resting potential and normal
functional activity during the refractory phase in an action potential. By
blocking these currents, dexmedetomidine can accentuate inhibition of
neuronal conduction and produce analgesia.
Severe pain is associated with proximal femur fracture .Use of regional
anesthesia (RA) has been associated with reduced opioid consumption
in postoperative period, thereby enabling early mobilization and fewer
opioid related side effects.Some case series and randomized control
studies suggest PENG block as an effective alternative to femoral nerve
block and fascia iliaca block for femur fracture pain relief.
However, there is no RCT comparing the analgesic effect of
Dexmedetomidine and Bupivacaine compared to Bupivacaine alone in
the PENG block
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •criteria:ASA 1,2,3 patients of 18 to 60 years of age with only proximal femur fractures (neck of femur, intertrochanteric, and subtrochanteric fractures) undergoing surgery under spinal anaesthesia, having significant pain visual analogue scale (VAS) ≥4 and expected surgery duration of less than 150 min.
排除标准
- •Patients with old fractures (more than 7 days), polytrauma, bleeding disorders or coagulopathy, local site infection, difficulty expressing pain scores such as hearing disability, mentally challenged, dementia or psychiatric illness,patients on chronic opioids or drug addicts.
结局指标
主要结局
Duration of analgesia
时间窗: FIRST 24HOURS
次要结局
- Ease of spinal position score (EOSP)(30 minutes after the block)
- Postoperative pain scores(at .5h,2h, 4h,6h,12h,24h)
- Quadriceps weakness(At 6 hours postoperatively)
- Total number of rescue analgesics in first 24 hours(24 hours)
- Postoperative inflammatory stress response(Preoperative,1 hour postoperatively)
- Side effects ,if any(24 hours)
研究者
Ruchi Singh
Government institute of medical sciences