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临床试验/NCT00620477
NCT00620477已完成4 期

Evaluation of Arthroscopic Reconstruction of the Anterior Cruciate Ligament by One Night Hospital Stay or by Day Surgery: a Randomised, Prospective Clinical Trial

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年7月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Visual Analogue Scale

研究概览

简要总结

Patients who suffered from a rupture of the Anterior Cruciate Ligament with instability of the knee joint, will be treated with an operative ACL-reconstruction. One group of patients will stay one night in the hospital and go home the other day (Group I). The other group of patients will go home the same day of surgery (Group II). All patients will undergo the same arthroscopic reconstruction of the ACL. Anesthesia will be performed on each patient in a classic manner. At the end of the surgery each group of patients will be randomly divided in two subgroups: one group will get an injection in the knee joint with 20 ml of physiological fluid (Group Ia en IIa), the other group will get an injection in the knee joint with 20 ml of chirocaine 0.125%, a widely used pain-medicine (Group Ib and IIb). This will happen in a double blind, randomized way. The whole procedure takes about one hour. After surgery patients are brought to the recovery room and are observed every 30 minutes for the duration of 4 hours. Before being brought to their rooms, patients will have to fill in a VAS: Visual Analogue Scale, to determine their pain. After being brought to their rooms, the patients will have the choice of going home the same day or staying in the hospital for one night, according to the amount of pain they are in. That moment it will be possible to switch groups. Patients who go home the same day of surgery will be contacted by phone the day after to fill in a question form. Patients who were admitted for one night will be seen before their leave to fill in the same question form.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who suffered from a isolated rupture of the Anterior Cruciate Ligament with instability of the knee joint will be included in the study.
  • Patients with a meniscal tear that can be sutured will also be included. Partial meniscectomies are accepted.

排除标准

  • Patients with chronic laxity (longer than 9 months), associated collateral laxity (grade III), subtotal or total meniscectomy, infection or inflammatory disease of the knee joint or large cartilage lesion will not be included in the study.

研究组 & 干预措施

1

Experimental

injection in the knee joint with 20 ml of chirocaine 0.125%

干预措施: injection in the knee joint with 20 ml of chirocaine 0.125% (Drug)

2

Placebo Comparator

injection in the knee joint with 20 ml of physiological fluid

干预措施: injection in the knee joint with 20 ml of physiological fluid (Drug)

结局指标

主要结局

Visual Analogue Scale

时间窗: within 4 hours after surgery

次要结局

  • Question Form, Visual Analogue Scale(one day after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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