Randomized control study to assess the analgesic efficacy of Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound Guided Femoral Nerve Block in Patients Undergoing Elective Surgery for Fracture Shaft of Femur in department of Anaesthesia, SMS Medical college Jaipur
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1.To assess & compare the difference in mean time of first rescue analgesia in both groups by using NRS score.
研究概览
简要总结
After obtaining Institutional Ethics Committee approval and written informed consent, 90 patients fulfilling inclusion criteria and undergoing elective surgery for fracture shaft of femur under spinal anaesthesia will be included.
Preoperative visit will be conducted on the previous day of surgery and detailed Pre-anaesthetic checkup (PAC) will be done. In the operation theatre, patient will be identified and received, written and informed consent, PAC, and fasting status will be checked. Routine non-invasive monitors will be attached and vital parameters like pre-operative pulse rate, non-invasive blood pressure, and oxygen saturation will be noted. Peripheral venous access will be established in upper limb with 18G IV cannula and intravenous Ringer Lactate solution will be started.
Patient randomization will be performed using opaque sealed envelope method.
GROUP A (n=45): Patients will receive ultrasound guided Femoral nerve block with 15 ml of 0.25% bupivacaine and 2ml NS (total volume 17 ml)
GROUP B (n=45): Patients will receive ultrasound guided Femoral nerve block with 15 ml of 0.25% bupivacaine and 1ug /kg of dexmedetomidine dilute in NS to make 2 ml (Total volume 17 ml)
Depending on the allotted group, under all aseptic precautions, patients will receive the respective block under ultrasound guidance in the Operation Theatre. NRS score will be assessed at every 1 min interval up to 20 min until the NRS is <3. This time will be noted. When NRS will be < 3 under all aseptic precautions subarachnoid block will be given in sitting position in L3-L4 space with 0.5% hyperbaric bupivacaine 12.5 mg +25 microgram of fentanyl using 25G Quincke’s needle. When adequate sensory and motor blockade will be achieved, surgery will be started. Intraoperative parameters such as Heart Rate, SBP, DBP, MAP and SpO2 will be monitored according to proforma. When surgery will be completed patients will be shifted to PACU. Inj. Tramadol 100 mg will be given as rescue analgesic and vitals will be monitored for 24 hours. Side effects, if any, will be noted, and managed accordingly.
In postoperative period
- NRS score will be assessed at hourly interval for 6 hours then at every 2 hour interval for 12 hours and then 4 hour interval for 24 hours.
- Time for need for first rescue analgesia will be recorded. This time will be calculated from the time of administering the block to request of first rescue analgesia by patient at NRS score >3.
- The mean dose of analgesic required for 24 hours in both groups will be noted.
- Quadriceps muscle strength will be assessed.
- Sedation score and Patient satisfaction will be assessed.
- Haemodynamic parameters will be monitored as per proforma.
- Side effects/complications if any will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient undergoing elective surgery for fracture shaft of femur.
- •Patients consenting to participate.
- •Adult patients aged 20-70 Years.
- •Patients belonging to American Society of Anesthesiologists (ASA) grade I, II and III.
排除标准
- •Patients with psychiatric illness, anxious, agitated.
- •Patients with peripheral sensorineural deficit.
- •Patients allergic to local anesthetics.
- •Patients with contraindications to regional anaesthesia.
- •Patients with suspected compartment syndrome in lower limbs.
- •Patients on analgesia within 8 hours before performing nerve block.
- •Block failure cases(If NRS score is not < 3 within 20 min of performing peripheral nerve block).
结局指标
主要结局
1.To assess & compare the difference in mean time of first rescue analgesia in both groups by using NRS score.
时间窗: 24 hours post operatively
3.To determine the difference in mean dose of analgesic required for 24 hours in both groups.
时间窗: 24 hours post operatively
2.To observe change in NRS at one minute interval maximum up to 20 minutes after administration of block until NRS 3 for positioning of patient for spinal anaesthesia in both groups
时间窗: 24 hours post operatively
次要结局
- 1.To assess quadriceps muscle strength using Oxford muscle strength grading.(2.To determine the change in the hemodynamic parameters (HR,SBP,DBP,MAP & SpO2) in both groups.)