The Effects of Different Dose Levels of Peri-neural Dexmedetomidine on the Pharmacodynamic and Side Effects Profiles of Bupivacaine-induced Ultrasound-guided Femoral Nerve Block
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- duration of sensory block
研究概览
简要总结
The duration of sensory block after single dose of long acting local anesthetics is not sufficient to avoid the postoperative use of opioids. Alpha-2 adrenoceptor agonists such as clonidine have been shown to increase the duration of peripheral nerve block. Dexmedetomidine is a more potent and selective α-2-adrenoceptor compared to clonidine. To the best of our knowledge, the use of Dexmedetomidine in different dose levels as adjuvant to local anesthetic was not previously reported for femoral nerve block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients with ASA physical status I or II, scheduled for arthroscopic knee surgery
排除标准
- •Patients who are refusing regional block, patients with diabetic peripheral neuropathy, renal or hepatic dysfunction, inflammation or infection at the puncture site, and history of allergic reaction to study medications
研究组 & 干预措施
group B: control bupivacaine group
Patient in this group will receive 25 ml bupivacaine 0.5% plus 1 ml normal saline peri-neurally
干预措施: peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block (Drug)
group B: control bupivacaine group
Patient in this group will receive 25 ml bupivacaine 0.5% plus 1 ml normal saline peri-neurally
干预措施: Placebo (Drug)
Group B-DEX 25 : Peri-neural Dexmedetomidine
Patients in this group will receive 25 ml of 0.5% bupivacaine plus 1 ml (25 microgram) Dexmedetomidine peri-neurally
干预措施: peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block (Drug)
Group B-DEX 50:Peri-neural Dexmedetomidine
Patients in this group will receive 25 ml of 0.5% bupivacaine plus 1 ml (50 microgram) Dexmedetomidine peri-neurally
干预措施: peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block (Drug)
Group B-DEX 75:Peri-neural Dexmedetomidine
Patients in this group will receive 25 ml of 0.5% bupivacaine plus 1 ml (75microgram) Dexmedetomidine peri-neurally
干预措施: peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block (Drug)
结局指标
主要结局
duration of sensory block
时间窗: Every 5 minutes for the first 30 minutes after end of study medications injection, then postoperatively every 2 hours till complete recovery of normal sensation.
the time interval between the onset of the sensory block and the complete resolution of normal sensation. Over a period of 30 min after injection of the study medications and every 2 hours postoperatively till complete recovery of normal sensation; a blinded investigator will assess sensory block with pinprick test using a 3-point scale: 0 ═ complete loss of sensation, 1 ═ partial loss of sensation and 2 ═ normal sensation. Pinprick test will be done in comparison to the contralateral area at the sensory distribution of the femoral nerve.
次要结局
- incidence of side effects.(from the injection time till 24 hours postoperatively)
- Time to first request of postoperative rescue analgesic(over the first postoperative 24hours)
- Richmond Agitation-Sedation Score (RASS)(2hours post operative and for 24hours)
- duration of motor block(Every 5 minutes for the first 30 minutes after end of study medications injection, then postoperatively every 2 hours till complete recovery of motor power.)
- perioperative hemodynamic parameters(will be recorded at 0, 15, 30 minutes after femoral nerve block, then every 10 minutes intraoperatively, and every 2 hours postoperative for a period of 12 hours.)
- Onset of sensory block(up to 30 minutes after the end of injection)
- Onset of motor block(up to 30 minutes after the end of injection)
- total morphine consumption(The first 24 hours postoperatively)
- visual analogue pain scores (VAS)(2hours post operative and for 24hours)
研究者
Heba Nassar,MD
lecturer of anesthesia
Cairo University