Dexmedetomidine versus Fentanyl as an Adjunct to Bupivacaine in Femoral Nerve Block: A comparitive Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- to compare the total duration of analgesia effect of dexmedetomidine and fentanyl as adjuvant to bupivacaine in femoral nerve block for postoperative analgesia .
研究概览
简要总结
Dexmedetomidine versus Fentanyl as an Adjunct to Bupivacaine in Femoral Nerve Block: A comparitive Study
Aims:We intend to compare the effect of dexmedetomidine and fentanyl as adjuvant to bupivacaine in femoral nerve block for postoperative analgesia in lower limb surgeries.
Patients and Methods
All patients will be randomly assigned into two groups (40 patients each).
• Group BD (No. =40)
· Group BF (No. =40)
Once fitness and primary assessment completed patient will be posted for surgery.
After shifting the patient to the induction room, ECG, pulse oximeter, noninvasive blood pressure monitors will be attached. Peripheral venous line will be established and an infusion of lactated ringers’ solution will be started.
Then femoralnerve block will be performed
Technique of ultrasound guided femoral nerve block
In this procedure drug will be given as described below
Group BD (No. =40): ultrasound guided femoral nerve block before spinal anesthesia will be done for each patient using (18 ml of 0.25% bupivacaine + 0.5 mcg/kg diluted in 2 ml saline to reach total volume 20 ml).
Group BF (No. =40): ultrasound guided femoral nerve block before spinal anesthesia will be done for each patient using (18 ml of 0.25% bupivacaine + 1mic/kg fentanyl diluted in 2 ml saline to reach total volume 20 ml).
before femoral nerve block (baseline),
• after block and before spinal anesthesia,
• immediately after spinal anesthesia, and
• every 30 minutes till end of surgery.
Ø Visual Analogue Scalewill be used for pain measurement at regular intervals as primary tool of observation and will be recorded every 30 min post operatively until the first dose of rescue analgesic is given.
Visual Analogue Scale:
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients In The Age Range 20-60 Years.
- •ASA Risk Category I And II.
- •No Known History Of Allergy, Sensitivity Or Other Form Of Reaction To Local Anesthetics Of The Amide Type.
排除标准
- •Patient Refusal.
- •Patients With Coagulopathy.
- •Patients On Potent Antiplatelets, Or On Anticoagulants.
- •Patients With Back & Spine Problems.
- •Patients With Local Skin Infections At Site Of Injection.
- •Known Allergy To The Trial Drugs.
- •Patients With Poor Myocardial Contractility.
- •Patients With Thoracic Spine Deformity.
- •ASA III Or More.
结局指标
主要结局
to compare the total duration of analgesia effect of dexmedetomidine and fentanyl as adjuvant to bupivacaine in femoral nerve block for postoperative analgesia .
时间窗: Baseline, immediately after block, prior to spinal,5 mins ,30 mins,60 mins, 2 hours and 6 hourly thereafter
To calculate total analgesia requirement postoperatively.
时间窗: Baseline, immediately after block, prior to spinal,5 mins ,30 mins,60 mins, 2 hours and 6 hourly thereafter
次要结局
- Visual Analogue Scalewill be used for pain measurement(every 30 min post operatively until the first dose of rescue analgesic is given.)
- time of rescue analgesia(time at which first dose of analgesia given postoperatively)