Perineural Dexmedetomidine as an Adjuvant to Bupivacaine-induced Ultrasound-guided Femoral Nerve Block.
试验速览
- 阶段
- 4 期
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The primary outcome measure of this study will be the change of sensory block over time.
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 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
- 18 Years 至 45 Years（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 diagnostic knee arthroscopy
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 0.5 ml normal saline peri-neurally and 0.5 ml subcutaneous normal saline.
干预措施: peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block (Drug)
Group B-peri-DEX: Peri-neural Dexmedetomidine
Patients in this group will receive 25 ml of 0.5% bupivacaine plus 0.5 ml (50 microgram) Dexmedetomidine peri-neurally and 0.5 ml subcutaneous normal saline
干预措施: peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block (Drug)
Group B-sys-DEX:Systemic Dexmedetomidine
Patients in this group will receive 25 ml bupivacaine plus 0.5 ml saline peri-neurally and 0.5 ml (50 microgram) subcutaneous Dexmedetomidine.
干预措施: peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block (Drug)
结局指标
主要结局
The primary outcome measure of this study will be the change of sensory block over time.
时间窗: intraoperatively every 5 minutes for the first 30 minutes of the operation, then postoperatively every 2 hours for 24hours
Over a period of 30 min after injection of the study medications, 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 (10). Pinprick test will be done in comparison to the contralateral area at the sensory distribution of the femoral nerve
次要结局
- onset of motor and sensory block(up to 30 minutes after the end of injection)
研究者
Abeer Ahmed
lecturer of anesthesia
Cairo University