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临床试验/NCT04443634
NCT04443634Unknown不适用

Presurgical Adductor Canal Block (ACB) Versus ACB and Distal (Intermuscular) Saphenous Nerve Block in Patients Undergoing Anterior Cruciate Ligament Repair Under General Anaesthesia: Randomised Controlled Trial.

Cairo University1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2020年6月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
88
试验地点
1
主要终点
The total dose of morphine consumption in the first 24 hours postoperatively.

研究概览

简要总结

Knee surgeries are associated with severe postoperative pain. Blocking the femoral nerve (or saphenous nerve) in the adductor canal is increasingly used for knee analgesia. It carries potential benefits that encourage anesthesiologists to do it. It has a motor sparing property. Injection of local anesthetics in this lengthy canal that contains a variable amount of connective or fibrous tissue might lead to a patchy distribution of local anesthetics. Thus, the possibility of incomplete block of the saphenous nerve (most important nerve in knee innervations) cannot be excluded.

详细描述

Aim of the study is to compare the efficacy of the adductor canal block to the combined adductor canal block and saphenous nerve block at the distal third of thigh in the intermuscular plane between Vastus Medialis and Sartorius muscles in pain relief following knee arthroscopic anterior cruciate ligament repair.

After written informed consent, patients will be randomized in three groups:

Group (Adductor 20): Ultrasound guided adductor canal block will be performed with injection of 20 ml bupivcaine 0.5%.

Group (Adductor 30) Ultrasound guided adductor canal block will be performed with injection of 30 ml bupivacaine 0.5%. Group (Adductor/saphenous ): Ultrasound guided adductor canal block will be performed by injection of 20 ml bupivacaine 0.5%, combined with ultrasound guided saphenous

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled for knee orthopedic ( ACL repair)
  • Physical status ASA I, II.
  • Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.

排除标准

  • • Patients with known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).
  • History of psychological disorders and/or chronic pain.
  • Contraindication to regional anesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
  • Infection of the skin at the site of needle puncture area.
  • Patient refusal.
  • Severe respiratory or cardiac disorders.
  • Advanced liver or kidney disease.
  • Pregnancy.
  • Patient with surgery duration more than two hours.

研究组 & 干预措施

Adductor 20

Experimental

Ultrasound guided adductor canal block will be performed with injection of 20 ml bupivacaine

干预措施: Ultrasound Guided Adductor Canal Block (Procedure)

Adductor 20

Experimental

Ultrasound guided adductor canal block will be performed with injection of 20 ml bupivacaine

干预措施: General anesthesia (Procedure)

Adductor 20

Experimental

Ultrasound guided adductor canal block will be performed with injection of 20 ml bupivacaine

干预措施: Bupivacaine 20 ml (Drug)

Adductor 30

Experimental

Ultrasound guided adductor canal block will be performed with injection of 30ml bupivacaine

干预措施: Ultrasound Guided Adductor Canal Block (Procedure)

Adductor 30

Experimental

Ultrasound guided adductor canal block will be performed with injection of 30ml bupivacaine

干预措施: General anesthesia (Procedure)

Adductor 30

Experimental

Ultrasound guided adductor canal block will be performed with injection of 30ml bupivacaine

干预措施: Bupivacaine 30ml (Drug)

Adductor /Saphenous

Experimental

Ultrasound guided adductor canal block will be performed by injection of 20 ml bupivacaine , combined with ultrasound guided saphenous nerve block at the distal third of the thigh in the intermuscular plane between Vastus Medialis and Sartorius muscle with injection of 10ml bupivacaine 0.5%.

干预措施: Ultrasound Guided Adductor Canal Block (Procedure)

Adductor /Saphenous

Experimental

Ultrasound guided adductor canal block will be performed by injection of 20 ml bupivacaine , combined with ultrasound guided saphenous nerve block at the distal third of the thigh in the intermuscular plane between Vastus Medialis and Sartorius muscle with injection of 10ml bupivacaine 0.5%.

干预措施: Ultrasound Guided Saphenous Nerve Block (Procedure)

Adductor /Saphenous

Experimental

Ultrasound guided adductor canal block will be performed by injection of 20 ml bupivacaine , combined with ultrasound guided saphenous nerve block at the distal third of the thigh in the intermuscular plane between Vastus Medialis and Sartorius muscle with injection of 10ml bupivacaine 0.5%.

干预措施: General anesthesia (Procedure)

Adductor /Saphenous

Experimental

Ultrasound guided adductor canal block will be performed by injection of 20 ml bupivacaine , combined with ultrasound guided saphenous nerve block at the distal third of the thigh in the intermuscular plane between Vastus Medialis and Sartorius muscle with injection of 10ml bupivacaine 0.5%.

干预措施: Bupivacaine 20 ml (Drug)

Adductor /Saphenous

Experimental

Ultrasound guided adductor canal block will be performed by injection of 20 ml bupivacaine , combined with ultrasound guided saphenous nerve block at the distal third of the thigh in the intermuscular plane between Vastus Medialis and Sartorius muscle with injection of 10ml bupivacaine 0.5%.

干预措施: Bupivacaine 10ml (Drug)

结局指标

主要结局

The total dose of morphine consumption in the first 24 hours postoperatively.

时间窗: 24 hours postoperative

The total amount of morphine consumption in the first 24 hours postoperatively.

次要结局

  • Failure rate of the block(24 hours)
  • Block related complications(1 mounth)
  • Total dose of intraoperative fentanyle adminstration(2 hours intraoperatively)
  • Numeric Pain Rating Scale(24 hours postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bassant M. Abdelhamid

associate professor

Cairo University

研究点 (1)

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