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临床试验/NCT04759742
NCT04759742已完成早期 1 期

The Optimal Dosage of Ropivacaine for Arthroscopic Knee Surgery

Yanchao Yang1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2021年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
115
试验地点
1
主要终点
the median effective dose (ED) of ropivacaine in knee arthroscopic surgery

研究概览

简要总结

Fast-track Surgery (FTS ) refers to the application of various proven effective methods in perioperative period to reduce stress and complications and accelerate the recovery of patients.Nowadays, FTS has been successfully applied in clinical practice."FTS" truly embodies the concept of "patient-centered" and the direction of medical development.

Lower limb joint damage (the meniscus, and patellar ligament, etc.) is the joint movement orthopedic common disease, often characterized by joint swelling, pain, sports relaxation instability, thigh muscle atrophy, most can't continue to pursue the original movement, even unbend and flexor limited activity, result in patients with walking difficulties, serious impact on the patient's quality of life.Practice has proved that minimally invasive surgery under arthroscopy is the best way to treat such injuries. According to literature reports, the average hospital stay after arthroscopy is 5~7 days, while successful application of FTS can shorten it to 2~3 days.

Anesthesia plays an important role in the process of FTS.Compared with general anesthesia, intra-spinal anesthesia can effectively reduce the incidence of postoperative complications in patients, such as ventilator-related lung injury, deep vein thrombosis, cardiovascular and cerebrovascular accidents, and acute renal failure.Ropivacaine is a long-acting amide local anesthetic. Compared with bupivacaine, it is more and more widely used in spinal anesthesia due to its advantages of lower degree of motor nerve block and weaker toxicity to central nervous system and cardiac.However, the optimal dosage of ropivacaine for arthroscopic surgery is still unclear. Conventional dosage makes patients unable to move 2-4h after surgery and unable to urinate autonomically. Therefore, this study aims to optimize the dosage of ropivacaine for spinal anesthesia and enable patients to recover motor function at an early stage.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Patients undergoing elective arthroscopic knee surgery
  • ASA: grade I to III

排除标准

  • There are contraindications to spinal anesthesia
  • Allergic to local anesthetics
  • Patient refused

研究组 & 干预措施

group Ropivacaine

Experimental

The recommended administration concentration of ropivacaine in the subarachnoid space was 0.5% and the dose was 2-3ml (practical clinical anesthesiology). Based on previous clinical experience, the starting dose of ropivacaine was set at 12.5mg (2.5ml) and Dixon's up-and down method was adopted (Dixon WJ, Massey FJ Jr. Introduction to Statistical Analysis. NY: McGraw-Hill;1969. P. 344.) The dose of ropivacaine in the next patient was adjusted to 0.5mg (0.1 mL) according to the results of the previous patient's trial.

干预措施: ropivacaine (Drug)

结局指标

主要结局

the median effective dose (ED) of ropivacaine in knee arthroscopic surgery

时间窗: from preoperative to postoperative 24 hours

The primary outcome of this present study was the median effective dose (ED) of ropivacaine in knee arthroscopic surgery to allow immediate postoperative mobilization as well as adequate anesthesia during surgery.The up and down method as described by Dixon and Massey was used.This is a sequential allocation model in which patients received a dose of ropivacaine according to the outcome of the preceding patient. A starting dose of the test sequence was set to 12.5 mg ropivacaine .The dose of ropivacaine in the next patient was increased or decreased according to the experimental results of the previous patient, and the adjusted dose was 0.5mg.

次要结局

未报告次要终点

研究者

发起方
Yanchao Yang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yanchao Yang

Principal investigator

Shengjing Hospital

研究点 (1)

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