Ultrasound Guided Single Shot Adductor Canal Block (ACB) Versus Single Shot Femoral Nerve Block (FNB) for Postoperative Analgesia After Arthroscopic Anterior Cruciate Ligament (ACL) Reconstruction in Pediatrics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Quadriceps Muscle Strength in Kilogram-force (Kgf)
研究概览
简要总结
Both Ultrasound guided Adductor Canal Block ( ACB) and Femoral Nerve Block (FNB) has been used to provide postoperative analgesia for knee surgeries. To the investigators' knowledge, no comparison has been made between those blocks in relation to postoperative quadriceps muscle strength, or duration and quality of postoperative analgesia for arthroscopic ACL reconstruction in pediatrics. If ACB provides postoperative analgesia after arthroscopic knee surgery comparable to FNB, it has the potential to improve the postoperative outcome as it will lead to less quadriceps muscle weakness and early mobilization, both of which are very important in the early postoperative period.
详细描述
Motor preservation with adequate analgesia has become the optimal postoperative goal in orthopedic surgeries, in particular knee surgeries. This enables earlier physical therapy, faster recovery and shorter hospital stays. Both Ultrasound guided ACB and FNB has been used to provide postoperative analgesia for knee surgeries, including anterior cruciate ligament reconstruction . To the investigators' knowledge, no comparison has been made between both blocks in relation to postoperative quadriceps muscle strength as well as duration and quality of postoperative analgesia for arthroscopic ACL reconstruction. ACB predominantly block the sensory component of the femoral nerve without much effect on the motor component. Hence, it can lead to less quadriceps muscle weakness, early postoperative mobilization and decreases the incidence of postoperative fall . With the advent of ultrasonography, the adductor canal can be easily visualized at the mid-thigh level, allowing performance of ACB with a high success rate . In recent years, ACB has been successfully used for postoperative pain control after knee surgery . Anatomical study of adductor canal demonstrated that the adductor canal may serve as a conduit for more than just the saphenous nerve, possibly including the vastus medialis nerve, medial femoral cutaneous nerve, articular branches from the obturator nerve, as well as the medial retinacular nerve . Thus, the sensory change is not limited to the distribution of the saphenous nerve but includes the medial and anterior aspects of the knee from the superior pole of the patella to the proximal tibia.To the investigators Knowledge there has not been a randomized controlled study comparing ACB with FNB after Arthroscopic Anterior Cruciate Ligament (ACL) reconstruction. This prospective, double-blinded, randomized, controlled study will test the hypothesis that ACB would be associated with less quadriceps motor weakness than FNB at 4 hours after block performance . The investigators also hypothesize that ACB will provide analgesia to the anterior knee that is not inferior to FNB and not different in opioids usage at 4 and 24 hours after Peripheral Nerve Block (PNB) performance .
- Hypothesis ACB would be associated with less quadriceps motor weakness than FNB and provide postoperative analgesia comparable to FNB in quality and duration as determined by Numeric Scale (NS) pain scores and opioid use a 4 and 24 hours after PNB.
- Objectives
To compare FNB and ACB regarding:
- Quadriceps muscle strength at 4 hours after PNB performance.
- Pain scores at anterior knee at 4 hours and 24 hours after PNB as assessed by Numeric Scale (NS) pain scoring system. Also pain site other than the anterior knee will be recorded and specified (posterior knee, calf, leg)
- Total opioid consumption at 4 and 24 hours after PNB.
- Study Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I or II
- •Age 8 to 18 years
- •All research subjects must have an acceptable legally authorized representative capable of giving consent on the subject's behalf.
排除标准
- •Those who were unable to use a standard 0-10 NS
- •Infection at the site of the block
- •Bleeding disorders
- •Allergy to the drugs used to perform the block ( ropivacaine , methylprednisolone)
- •Those who refused a nerve block or enrollment in the study.
研究组 & 干预措施
Adductor Canal block
Adductor Canal Block performed at mid-thigh level to block the saphenous nerve under guidance of a linear ultrasound transducer probe (General Electric; GE). Performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg ( maximum of 40 mg ).
干预措施: Adductor Canal Block (Procedure)
Adductor Canal block
Adductor Canal Block performed at mid-thigh level to block the saphenous nerve under guidance of a linear ultrasound transducer probe (General Electric; GE). Performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg ( maximum of 40 mg ).
干预措施: Ultrasound (Device)
Adductor Canal block
Adductor Canal Block performed at mid-thigh level to block the saphenous nerve under guidance of a linear ultrasound transducer probe (General Electric; GE). Performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg ( maximum of 40 mg ).
干预措施: Stimuplex A needle (Device)
Adductor Canal block
Adductor Canal Block performed at mid-thigh level to block the saphenous nerve under guidance of a linear ultrasound transducer probe (General Electric; GE). Performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg ( maximum of 40 mg ).
干预措施: local anaesthetic injection (Drug)
Adductor Canal block
Adductor Canal Block performed at mid-thigh level to block the saphenous nerve under guidance of a linear ultrasound transducer probe (General Electric; GE). Performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg ( maximum of 40 mg ).
干预措施: Steroid Drug (Drug)
Femoral Nerve block
Femoral Nerve Block performed under guidance of a linear ultrasound transducer probe (General Electric;GE).Block will be performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg (maximum of 40 mg ).
干预措施: Femoral Nerve Block (Procedure)
Femoral Nerve block
Femoral Nerve Block performed under guidance of a linear ultrasound transducer probe (General Electric;GE).Block will be performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg (maximum of 40 mg ).
干预措施: Ultrasound (Device)
Femoral Nerve block
Femoral Nerve Block performed under guidance of a linear ultrasound transducer probe (General Electric;GE).Block will be performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg (maximum of 40 mg ).
干预措施: Stimuplex A needle (Device)
Femoral Nerve block
Femoral Nerve Block performed under guidance of a linear ultrasound transducer probe (General Electric;GE).Block will be performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg (maximum of 40 mg ).
干预措施: local anaesthetic injection (Drug)
Femoral Nerve block
Femoral Nerve Block performed under guidance of a linear ultrasound transducer probe (General Electric;GE).Block will be performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg (maximum of 40 mg ).
干预措施: Steroid Drug (Drug)
结局指标
主要结局
Quadriceps Muscle Strength in Kilogram-force (Kgf)
时间窗: 4 hours following peripheral nerve block performance
Measuring the quadriceps muscle strength (surgical side) using a dynamometer.Patients were placed supine with a cushion underneath their knee, resulting in a 45-degree angle at the knee. A dynamometer was placed on the anterior of the ankle, between the malleoli. Patients were instructed to extend their legs three times each, with a 30-s pause between each attempt (Lafayette Manual Muscle Test System; Lafayette Instrument Company, Lafayette, IN; and all three dynamometer readings in Kgf unit for each leg were recorded.Kgf is a gravitational metric unit force ,it is equal to the magnitude of the force exerted on one kilogram of mass under standard gravity.
Post-operative Pain Scores Using the Numeric Pain Scoring System (NS)
时间窗: 4 hours and 24 hours
Assessed by Numeric Scale (NS) pain scoring system. Minimum 0 and maximum 10 . Higher scores means worse outcome (pain)
Total Opioid Consumption at 24 Hours Post-block
时间窗: 24 hours following peripheral nerve block performance.
Total intravenous morphine/morphine equivalent consumption in milligrams (mg) at 24 hours post-block
次要结局
未报告次要终点
研究者
Rami Karroum
Staff Anethesiologist,M.D.
Akron Children's Hospital