Optimal Volume of Bupivacaine in Adductor Canal Nerve Block in Patients Undergoing Unilateral Cruciate Ligament Reconstruction Surgery
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in quadriceps motor force measured in kg*m/sec2
研究概览
简要总结
To establish adequate volume of levobupivacaine 0.25% in adductor canal nerve block in unilateral cruciate ligament of the knee reconstruction surgery.
详细描述
The complex knee surgery has been associated with severe postoperative pain. Different analgesic techniques for postoperative management of this increasingly common surgery, with main purpose of adequately control pain, minimizing adverse effects and seeking early rehabilitation.
Currently, the most used technique is the continuous femoral nerve block, which is able to control postoperative pain well, but has the limitation that also produces motor blockade, decreasing quadriceps strength up to 80%, increasing the number of falls and delaying early mobilization after surgery. On the other hand, the adductor canal nerve block is an alternative as it is considered a purely sensitive block. The nerves that are in this channel are the saphenous adductor nerve, posterior branches of the obturator nerve, medial vast nerve, sometimes the medial cutaneous nerve and anterior branches of the obturator nerve and the vast medial nerve.
With regard to the adductor canal block, current literature supports analgesic effect comparable to femoral nerve block with less motor block than femoral nerve block. However, there is no clarity regarding the ideal concentration and volume of local anesthetics to use. Volumes ranging from 5 to 30 ml have been used in different studies. For example, using 20 mL of local anesthetic in femoral nerve block has produced scattering of anesthetic that has blocked motor branches.
The investigators objective is to determine which volume of levobupivacaine 0.25% is necessary to produce analgesia and sensitive blockade while minimizing motor blockade in adductor canal nerve block in patients undergoing cruciate ligament reconstruction surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •ASA status I or II
- •BMI between 20 and 34 kg/m2
- •Cruciate ligament of the knee reconstructive surgery
- •No contraindications to general and regional anesthesia
排除标准
- •Chronic pain more than 3 months
- •Drug abuse
- •Chronic use of analgesic drugs (more than 3 months)
- •Psychiatric illness
- •Peripheral neuropathy
- •Drug allergy
- •Severe gastroesophageal reflux disease
研究组 & 干预措施
A Levobupivacaine 5 mL
Adductor canal nerve block with levobupivacaine 0.25% 5 mL and perineural catheter placement, an elastomeric pump with bupivacaine 0.1% at a rate of 5 ml/hr will be placed after surgery for continuous nerve block.
干预措施: Levobupivacaine 5 mL (Drug)
B Levobupivacaine 10 mL
Adductor canal nerve block with levobupivacaine 0.25% 10 mL and perineural catheter placement, an elastomeric pump with bupivacaine 0.1% at a rate of 5 ml/hr will be placed after surgery for continuous nerve block.
干预措施: Levobupivacaine 10 mL (Drug)
C Levobupivacaine 15 mL
Adductor canal nerve block with levobupivacaine 0.25% 15 mL and perineural catheter placement, an elastomeric pump with bupivacaine 0.1% at a rate of 5 ml/hr will be placed after surgery for continuous nerve block.
干预措施: Levobupivacaine 15 mL (Drug)
D Levobupivacaine 20 mL
Adductor canal nerve block with levobupivacaine 0.25% 20 mL and perineural catheter placement, an elastomeric pump with bupivacaine 0.1% at a rate of 5 ml/hr will be placed after surgery for continuous nerve block.
干预措施: Levobupivacaine 20 mL (Drug)
E Levobupivacaine 25 mL
Adductor canal nerve block with levobupivacaine 0.25% 25 mL and perineural catheter placement, an elastomeric pump with bupivacaine 0.1% at a rate of 5 ml/hr will be placed after surgery for continuous nerve block.
干预措施: Levobupivacaine 25 mL (Drug)
F Levobupivacaine 30 mL
Adductor canal nerve block with levobupivacaine 0.25% 30 mL and perineural catheter placement, an elastomeric pump with bupivacaine 0.1% at a rate of 5 ml/hr will be placed after surgery for continuous nerve block.
干预措施: Levobupivacaine 30 mL (Drug)
结局指标
主要结局
Change in quadriceps motor force measured in kg*m/sec2
时间窗: Before nerve block (basal) and 24 hours after surgery
Using a dynamometer in anterior tibial muscle
次要结局
- Pain(Before surgery, 30 minutes after nerve block, one hour after surgery, 48 hours after surgery)
- Rescue analgesia(24 hours and 48 hours after surgery)
- Patient satisfaction(48 hours after surgery)
- Change in quadriceps force measured by 30-second chair stand test(Before nerve block (basal) and 24 hours after surgery)
- Sensitivity block(30 minutes after adductor canal block)