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临床试验/NCT02411890
NCT02411890已完成4 期

The Comparison of Postoperative Analgesia Between Adductor Canal Block and Femoral Nerve Block After Arthroscopic ACL Reconstruction With Hamstring Graft: A Randomized Controlled Trial

Thammasat University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
60
试验地点
2
主要终点
Pain score (VAS) during activity

研究概览

简要总结

The aim of this study is to compare the efficacy in pain relief within 24 hours between adductor canal block and femoral nerve block after anterior cruciate ligament reconstruction with hamstring graft.

详细描述

After approval from institutional ethic committees, Thammasat University Hospital, patients who meet the eligible criteria will be asked for informed consent. Randomization will be performed by computerization with varied block sizes (4 and 6), and the sequence of randomization will be concealed by sealed envelopes. Once given informed consent, the investigator opened the sealed envelope, which randomized the patient to the adductor canal block group (ACB), or the femoral nerve block group (FNB).

The day before surgery day, patients who meet the eligible criteria will ask for the informed consent from blinded research assistant. They will obtain patients' demographic data, preoperative pain scores, and quadriceps strength. They will be recommended how to evaluate pain score and use the patient-controlled analgesia.

In the block room, patients will be sedated with midazolam 2-3 mg intravenously. The nerve block will be performed before spinal anesthesia by unblinded anesthesiologists. During block, the patients will be blinded by sham block. In ACB group, patients will receive sham block of femoral nerve at inguinal area, and then ACB will be performed, while in FNB group, patients will receive FNB, and then sham block will be performed in the mid-femoral area.

After standard monitored, the saphenous nerve will be blocked in the ACB group under ultrasound guidance using linear probe (9 mHz, GE Healthcare®) with nerve stimulator (Payunk®) at midfemoral level. When the needle tip is positioned, the nerve stimulator is turned on and set to deliver a current of 0.5 mA at a frequency of 2 Hz and pulse duration of 0.1 ms. The presence of a quadriceps muscle twitch, if elicited, will be recorded, and the needle was re-positioned until the muscle twitch disappeared. Then, 0.5% levobupivacaine with adrenaline 5 µg/ml 15 ml will be injected.

The femoral nerve block is also performed in the FNB group under ultrasound guidance using linear probe (9 mHz, GE Healthcare®) and nerve stimulator (Payunk®). With ultrasound guidance, the femoral nerve is identified in femoral triangle near to femoral artery, and when the needle tip is in proper position in the ultrasound image, the nerve stimulator is used to confirm, the presence of quadriceps twitching at the current less than 0.5 mA, and the absence of quadriceps twitching at the current more than 0.2 mA. After that, 30 ml of 0.25% levobupivacaine with adrenaline 5 µg/ml is injected.

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
15 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • arthroscopic anterior cruciate ligament reconstruction with hamstring graft at Thammasat University Hospital.
  • age 15-80 years
  • ASA class I-III

排除标准

  • refuse to participate the study
  • morbid obesity (BMI ≥ 35 kg.m2)
  • allergic to any medication in the study
  • chronic opioid use or abuse
  • lower extremity neurological dysfunction
  • patients who cannot cooperate and assess pain score themselves.

结局指标

主要结局

Pain score (VAS) during activity

时间窗: 24 hours postoperative

Pain score during activity measured on Visual Analog Scale postoperative 24 hours. Adductor canal block VS Femoral nerve block

次要结局

  • Opioid consumption(0-24 hours postoperative)
  • Pain score (VAS) at rest(4, 8, 12, 16, 20, 24 hours postoperative)
  • Pain score (VAS) at activity(4, 8, 12, 16, 20 hours postoperative, and during quadriceps strength testing)
  • duration (hours) after surgery-first time that patients pressing PCA(0-24 hours postoperative)
  • Postoperative pruritus or rash(0-24 hours postoperative)
  • The reduction of quadriceps strength from preoperative period both knees(8-12, 24 hours)
  • Postoperative nausea and vomiting(0-24 hours postoperative)
  • Postoperative urinary retention(0-24 hours postoperative)
  • Postoperative respiratory depression(0-24 hours postoperative)

研究者

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

Alisa Seangleulur

Department of Anesthesiology, Thammasat University

Thammasat University

研究点 (2)

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