Effects of Sono-guided Femoral Nerve Block in Arthroscopic Surgery for Anterior Cruciate Reconstruction Under General Anesthesia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- postoperative pain after 24hours
研究概览
简要总结
The investigators will compare the results of sono-guided femoral nerve block in arthroscopic surgery for anterior cruciate ligament reconstruction under general anesthesia.
详细描述
This study is a randomized controlled trial of 100 patients, who underwent history taking, physical examinations, x-rays, and MRI or ultrasonography, and were diagnosed with anterior cruciate ligament rupture from september 2023 to august 2028. The 100 patients will be assigned to Group I (with femoral nerve block) or Group II (without femoral nerve block) under double-blinded randomization. The randomization will be performed by an independent nurse using a computerized random sequence generator. The operators who participated in the procedure will be blinded to the participant's information. Both group will undergo general anesthesia for arthroscopic anterior cruciate ligament reconstruction. After anesthesia, sono-guided femoral nerve block will be performed. The injection for group1 is 20 mL ropivacaine and for groupII is 20 mL 0.9% saline. A visual analog scale (VAS) for pain will be recorded 1, 3, 6, 12, 18, 24, 36, 48 hours after the operation. VAS scores range from 0 to 10, with 0 being no pain and 10 being the most severe pain ever experienced. Injection with ultrasonography will be performed by a single anesthesiologist. 3 orthopedic surgeons will perform the surgery.
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
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •individuals who are scheduled to undergo arthroscopic anterior cruciate ligament reconstruction surgery and must be received sufficient explanation about the research prior to surgery and have provided their informed consent to participate.
排除标准
- •who require simultaneous surgery for concomitant cartilage injury, medial meniscus tear, and lateral collateral ligament tear.
- •who have previously undergone surgical treatment within the knee joint.
- •who have declined to participate in the research.
- •where medical, surgical, or anesthetic complications occurred during surgery.
- •other cases deemed necessary by the researchers.
研究组 & 干预措施
FNB
sono-guided injection with 20ml ropivacaine
干预措施: Sono-guided injection (Procedure)
FNB
sono-guided injection with 20ml ropivacaine
干预措施: Ropivacaine injection (Drug)
no FNB
sono-guided injection with 20ml 0.9% saline
干预措施: Sono-guided injection (Procedure)
no FNB
sono-guided injection with 20ml 0.9% saline
干预措施: Saline injection (Drug)
结局指标
主要结局
postoperative pain after 24hours
时间窗: 24hours
VAS (Visual analog scale) measured 24 hours after operation * the unabbreviated scale title: The visual analog scale * the minimum and maximum values: 0, 10 * higher scores mean a worse outcome.
次要结局
- postoperative pain after 1, 3, 6, 12, 18, 48 hours(1, 3, 6, 12, 18, 48 hours)
研究者
Jung-Taek Hwang
Assistant Professor
Chuncheon Sacred Heart Hospital
