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临床试验/NCT06048848
NCT06048848尚未招募不适用

Effects of Sono-guided Femoral Nerve Block in Arthroscopic Surgery for Anterior Cruciate Reconstruction Under General Anesthesia: A Randomized Controlled Trial

Chuncheon Sacred Heart Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年9月18日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

sono-guided injection with 20ml ropivacaine

干预措施: Sono-guided injection (Procedure)

FNB

Experimental

sono-guided injection with 20ml ropivacaine

干预措施: Ropivacaine injection (Drug)

no FNB

Placebo Comparator

sono-guided injection with 20ml 0.9% saline

干预措施: Sono-guided injection (Procedure)

no FNB

Placebo Comparator

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

发起方
Chuncheon Sacred Heart Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jung-Taek Hwang

Assistant Professor

Chuncheon Sacred Heart Hospital

研究点 (1)

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